Clinical Trial Results:
A Phase II open-label, single-arm, multicenter trial of MP0250 plus bortezomib+dexamethasone in patients with refractory and relapsed multiple myeloma
|
Summary
|
|
EudraCT number |
2016-002771-10 |
Trial protocol |
DE PL DK AT CZ |
Global end of trial date |
13 Jan 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Sep 2021
|
First version publication date |
08 Sep 2021
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
MP0250-CP201
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03136653 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Molecular Partners AG
|
||
Sponsor organisation address |
Wagistrasse 14, Schlieren, Switzerland, 8952
|
||
Public contact |
Clinical Trial Manager, Molecular Partners AG, info@molecularpartners.com
|
||
Scientific contact |
Clinical Trial Manager, Molecular Partners AG, info@molecularpartners.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
11 May 2017
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
13 Jan 2021
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
There were 2 parts to this study. The main objectives for both parts were:
- Part 1: To estimate the efficacy of MP0250 plus bortezomib + dexamethasone, based on overall response rate (ORR), in patients with multiple myeloma (MM) who have received ≥2 lines of therapy, including bortezomib and an immunomodulatory drug (IMiD), and have shown no response to, or have progressed on the most recent treatment, or within 60 days of the most recent therapy.
- Part 2: To assess the preliminary efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory MM who have received ≥2 lines of therapy including a proteasome inhibitor (bortezomib, carfilzomib or both) and an IMiD (thalidomide, lenalidomide and/or pomalidomide) either alone or in combination and whose last line of therapy is either a bortezomib-or carfilzomib-based regimen.
|
||
Protection of trial subjects |
This study was conducted in accordance with the Note for Guidance on Good Clinical Practice (GCP) International Council for Harmonisation (ICH) Harmonised Tripartite Guideline E6 (R1)/Integrated Addendum E6 (R2); US Food and Drug Administration (FDA) Code of Federal Regulations (CFR) (Title 21 Parts 50, 56, 312), requirements for the conduct of clinical studies as provided in the EU Directive 2001/20/EC, the general guidelines indicated in the Declaration of Helsinki; and all applicable regulatory requirements.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Jan 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Poland: 12
|
||
Country: Number of subjects enrolled |
Czechia: 1
|
||
Country: Number of subjects enrolled |
Denmark: 1
|
||
Country: Number of subjects enrolled |
Germany: 13
|
||
Country: Number of subjects enrolled |
Italy: 6
|
||
Worldwide total number of subjects |
33
|
||
EEA total number of subjects |
33
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
22
|
||
From 65 to 84 years |
11
|
||
85 years and over |
0
|
||
|
||||||||||||||||
|
Recruitment
|
||||||||||||||||
Recruitment details |
Participants were enrolled at 24 research centers in Germany, Italy, Austria, Denmark, Poland, and Czechia from 11 May 2017 to 04 May 2020. The trial was terminated early on 04 May 2020 due to recent advances in the relapsed and refractory multiple myeloma (MM) treatment landscape. | |||||||||||||||
|
Pre-assignment
|
||||||||||||||||
Screening details |
Participants were enrolled into a lead-in phase (Part 1) for identification of the maximum tolerated dose (MTD) of MP0250. Part 2 enrolled additional participants for collection of additional safety and preliminary efficacy assessments. | |||||||||||||||
|
Period 1
|
||||||||||||||||
Period 1 title |
Overall Study: Parts 1 & 2 (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
|
|||||||||||||||
Blinding used |
Not blinded | |||||||||||||||
|
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
|
Arm title
|
8 mg/kg MP0250 | |||||||||||||||
Arm description |
Participants in Part 1 and Part 2 were administered 8 milligrams per kilogram of body weight (mg/kg) MP0250 as an intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 milligrams per square meter per dose (mg/m2/dose) as a subcutaneous (s.c.) injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
MP0250
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
|||||||||||||||
Routes of administration |
Concentrate for solution for infusion
|
|||||||||||||||
Dosage and administration details |
8 mg/kg as an IV infusion via peripheral or central venous line
|
|||||||||||||||
Investigational medicinal product name |
Bortezomib
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Powder for solution for injection
|
|||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||
Dosage and administration details |
1.3 mg/m^2/dose as a s.c. injection
|
|||||||||||||||
Investigational medicinal product name |
Dexamethasone
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
20 mg per oral (po) as an oral tablet
|
|||||||||||||||
|
Arm title
|
12 mg/kg MP0250 | |||||||||||||||
Arm description |
Participants in Part 1 were administered 12 mg/kg of body weight MP0250 as an IV infusion Q3W on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 mg/m2/dose as a s.c. injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
MP0250
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Concentrate for solution for infusion
|
|||||||||||||||
Routes of administration |
Concentrate for solution for infusion
|
|||||||||||||||
Dosage and administration details |
12 mg/kg as an IV infusion via peripheral or central venous line
|
|||||||||||||||
Investigational medicinal product name |
Bortezomib
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Powder for solution for injection
|
|||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||
Dosage and administration details |
1.3 mg/m^2/dose as a s.c. injection
|
|||||||||||||||
Investigational medicinal product name |
Dexamethasone
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Tablet
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
20 mg per oral (po) as an oral tablet
|
|||||||||||||||
|
||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
8 mg/kg MP0250
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants in Part 1 and Part 2 were administered 8 milligrams per kilogram of body weight (mg/kg) MP0250 as an intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 milligrams per square meter per dose (mg/m2/dose) as a subcutaneous (s.c.) injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
12 mg/kg MP0250
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants in Part 1 were administered 12 mg/kg of body weight MP0250 as an IV infusion Q3W on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 mg/m2/dose as a s.c. injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
8 mg/kg MP0250
|
||
Reporting group description |
Participants in Part 1 and Part 2 were administered 8 milligrams per kilogram of body weight (mg/kg) MP0250 as an intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 milligrams per square meter per dose (mg/m2/dose) as a subcutaneous (s.c.) injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | ||
Reporting group title |
12 mg/kg MP0250
|
||
Reporting group description |
Participants in Part 1 were administered 12 mg/kg of body weight MP0250 as an IV infusion Q3W on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 mg/m2/dose as a s.c. injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | ||
|
|||||||||
End point title |
Overall Response Rate (ORR) [1] [2] | ||||||||
End point description |
ORR defined as the percentage of participants achieving a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Myeloma Working Group (IMWG) as determined by the Investigator.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Day 1 until disease progression, death or discontinuation plus 7 days
|
||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were carried out for this end point. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The Full Analysis Set (FAS) for efficacy included all participants who were treated with 8 mg/kg MP0250 in Parts 1 and 2 and had measurable disease at baseline and completed at least 1 assessment of response. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
||||||||||||||||
End point title |
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | |||||||||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was any AE occurring or worsening on or after the first dose of study treatment, up to 28 days after the last dose of MP0250.
Severity of TEAEs were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, grades 3 or greater:
• Grade 3: severe
• Grade 4: life-threatening
• Grade 5: fatal
Clinically significant changes from baseline in laboratory analytes, vital signs and electrocardiogram (ECG) findings were also considered TEAEs.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Day 1 until 28 days after the last treatment
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||||||||
End point title |
Number of Participants With a Positive Anti-drug Antibody (ADA) Result | |||||||||||||||||||||
End point description |
ADA tests were performed at baseline, during study treatment, at the end of study treatment and at follow up.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Day 1 until disease progression, death or discontinuation
|
|||||||||||||||||||||
|
||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Average Range of ADA Titer in Participants who Tested Positive for ADA After Treatment | ||||||||||||||||||
End point description |
Serum samples were collected to analyze the titers of antibodies against MP0250. Values of 99999 indicate that no values could be calculated.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Day 1 until disease progression, death or discontinuation
|
||||||||||||||||||
|
|||||||||||||||||||
| Notes [3] - There were no participants who tested positive for ADA post-treatment. |
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
End point title |
Time-course of Anti-drug Antibodies (ADAs) | ||||||||||||
End point description |
The time to onset of ADA was defined as time (months) between the first day of study treatment and date of first detection of ADA.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 until disease progression, death or discontinuation plus 7 days
|
||||||||||||
|
|||||||||||||
| Notes [4] - No participants tested positive for ADA after treatment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||
End point title |
Progression-free Survival (PFS) [5] | ||||||||
End point description |
PFS was defined as the time in days from the first dose of MP0250 to progressive disease or death from myeloma. Deaths from other causes were censored. PFS was summarized using Kaplan-Meier (K-M) methodology.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1 until disease progression or death from myeloma
|
||||||||
| Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The Full Analysis Set (FAS) for efficacy included all participants who were treated with 8 mg/kg MP0250 in Parts 1 and 2 and had measurable disease at baseline and completed at least 1 assessment of response. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Duration of Response (DOR) [6] | ||||||||
End point description |
DOR was defined as the time from the earliest date of documented response (≥PR per the IMWG) to the first occurrence of disease progression or death from myeloma (with deaths from other causes censored). All responders were used for the response duration analysis, which was summarized using K-M estimates.
The value of 99999 indicates that the upper limit could not be calculated.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Day 1 until disease progression, death or discontinuation plus 7 days
|
||||||||
| Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The Full Analysis Set (FAS) for efficacy included all participants who were treated with 8 mg/kg MP0250 in Parts 1 and 2. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events: Day 1 until 28 days after the last treatment; Mortality: Day 1 until 30 days after the last treatment
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
All-cause mortality is reported for all participants who enrolled in the study (n=30 for 8 mg/kg; n=3 for 12 mg/kg). Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2 (n=28 for 8 mg/kg; n=3 for 12 mg/kg).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
8 mg/kg MP0250
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants in Part 1 and Part 2 were administered 8 mg/kg MP0250 as an IV infusion Q3W on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 milligrams per square meter mg/m2/dose as a s.c. injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
12 mg/kg MP0250
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants in Part 1 were administered 12 mg/kg of body weight MP0250 as an IV infusion Q3W on Day 1 of each cycle (1 cycle was 21 days) in combination with bortezomib 1.3 mg/m2/dose as a s.c. injection on Days 1, 4, 8, and 11 of each cycle and 20 mg dexamethasone as oral tablets on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [56] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [57] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [58] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [59] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [60] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [61] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [62] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [63] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [64] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [65] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [66] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [67] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [68] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [69] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [70] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [71] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [72] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [73] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [74] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [75] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [76] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [77] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [78] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [79] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [80] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [81] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [82] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [83] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [84] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [85] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [86] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [87] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [88] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. [89] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Non-serious adverse events are reported for all participants who received at least 1 dose of MP0250 in either Part 1 or Part 2. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
11 Jul 2017 |
• The exclusion criteria were modified.
• Screening assessment details were modified.
• An additional follow-up visit for safety was added to capture any AE after end of study (EoS) and end of the follow-up period.
• Criteria for the initiation of a New Cycle of Treatment were added.
• Treatment Dose Modification/Treatment Delay Recommendations section was modified in accordance with Investigator Brochure (IB) V3.0. In addition, further instructions were added for MP0250 and dexamethasone aiming to facilitate treatment and dose modifications. |
||
19 Dec 2018 |
• Primary objective for Part 2 under the new participant population was added describing that MM subjects who had received ≥2 lines of therapy, including bortezomib and IMiD, and had shown no response or progressed on most recent therapy and had received most recent therapy (must be a bortezomib- or carfilzomib-based regimen) were to be assessed for ORR.
• Study endpoints were modified:
○ Secondary safety endpoint - to include changes from baseline in selected laboratory analytes to further determine the safety profile of MP0250.
○ Secondary efficacy endpoint – to enable correct assessment of DOR from the first observation of PR or better until disease progression or death from myeloma according to the International Myeloma Workshop Consensus Panel 1.
• The number of participants to be enrolled was updated.
• Baseline disease assessments were modified to include all available imaging modalities considered standard of care in relapse/refractory multiple myeloma (RRMM).
• Overall Survival (OS) was modified to include OS visit after completion of follow-up period. Survival follow-up criteria were added.
• MP0250 dosing instructions were modified from 3 hours to 1 hour infusion followed by 25 mL 0.9% NaCl flush volume.
• Dexamethasone dosing instructions were modified for participants aged ≥75 years or considered frail by Investigator; it was recommended that this group of participants received reduced dexamethasone to avoid unnecessary toxicity.
• Dose modifications for MP0250 were modified since it had been demonstrated that the 12 mg/kg Q3W dose was insufficiently tolerated in Part 1.
• For Part 2 of the study, the dose-escalation committee (DEC) would review safety in the event of any unexpected safety signals. |
||
30 Jul 2020 |
• To reduce the intensity of study visits for ongoing participants, the Day 15 study visit of each cycle would no longer be performed.
• Analyses required for efficacy assessment and evaluation of primary and secondary endpoints would no longer be performed by central laboratory.
• Bone Marrow (BM) aspirate/biopsy, and assessment of soft tissue involvement were no longer required.
• Efficacy assessment was to be based on the local laboratory results; these data were not to be used for evaluation of primary and secondary endpoints but to assess whether the participant was responding and if a new cycle of study treatment was to be initiated.
• For participants who were discontinued from study treatment, no further efficacy assessments would be done following the end of treatment (EOT) visit.
• As the study was at an early stage and due to the consequential limited available data, survival data would no longer be collected.
• No further analyses of cytokine biomarker panel.
• No further fluorescence in-situ hybridization (FISH) analyses would be performed.
• Pharmacokinetics (PK) would be collected only on Day 1 of each cycle and at the EOT visit.
• EoS would occur 3 months after the last ongoing participant discontinued from study treatment (3-month follow-up visit), or death, withdrawal of consent, or lost to follow-up, whichever occurred earlier.
• The final analyses would occur when the last ongoing participant had switched to Protocol V4.0 or discontinued study treatment (regardless of the reason), whichever occurred first. For the primary analyses, the FAS that includes participants enrolled in Part 1 and Part 2 would be used.
• No further DEC data review meetings were anticipated. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| It was planned that up to 54 participants would enroll. However, recruitment was stopped by Sponsor decision on 04 May 2020, before this was achieved, as the study design no longer supported recent advances in the RRMM treatment landscape. | |||
