Clinical Trial Results:
Bone Study
Bone Healing During Ninlaro Exposure.
An open label phase 2 single centre clinical trial
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Summary
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EudraCT number |
2018-003258-25 |
Trial protocol |
DK |
Global end of trial date |
10 Jan 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jun 2025
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First version publication date |
11 Jun 2025
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Other versions |
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Summary report(s) |
Published article with 3 months results form the trial |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
X16120
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04028115 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Department of Hematology
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Sponsor organisation address |
Kløvervænget 6, Odense C, Denmark, 5000
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Public contact |
Odense University Hospital, Odense University Hospital, +45 65411156, birgitte.wolf.lundholm@rsyd.dk
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Scientific contact |
Odense University Hospital, Odense University Hospital, +45 65411156, birgitte.wolf.lundholm@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Dec 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jan 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study is to investigate if treatment with ixazomib can cause healing of preexisting osteolytic bone lesions in Multiple Myeloma.
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Protection of trial subjects |
In this trial, we did not give the study drug at first relapse but in a phase of temporary disease remission. Because of this, we did a full registration of adverse events observed during the trial.
Registration of adverse events started upon inclusion in the trial and ended 3 months after last dose of Ixazomib. Adverse events were graded according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0 with an indication of starting date and end date, relation to investigational drug, outcome and severity. All grade 3 and 4 adverse events, considered related to Ixazomib were followed until resolution of the event or the event improves to a grade 2 or better. The unresolved aforementioned events were followed for a maximum of 6 months. In case of side effects, Ixazomib dosing was reduced or discontinued according to protocol directions. Further the protocol descirbed actions to better AEs such as symptom relieving actions or medications. To avoid overdose of ixazomib patients were informed only to take ixazomib as prescribed and only one dose of ixazomib at a time.
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Background therapy |
Ixazomib was given together with acyclovir 400 mg x 2 per day to avoid reactivation of herpes zoster infection. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Oct 2019
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy, Scientific research | ||
Long term follow-up duration |
2 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
17
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
Patient were recruited at the Department of Hematology at Odense University Hospital from October 2019 to April 1 2024. Patients were recruited in the outpatient clinic during follow up appointments with their physician. | ||||||||||||
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Pre-assignment
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Screening details |
Patients screened to see if they conformed to the inclusion and exclusion criteria were patients with multiple myeloma in a stable remission with measurable bone disease on CT scan. Four patients were excluded during screening, due to low kidney function, not sufficient bone disease on scan, or due to infection. | ||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Intervention | ||||||||||||
Arm description |
Treatment with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
ixazomib
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Investigational medicinal product code |
MLN9708
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Other name |
Ninlaro
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
4 mg on day 1, 8, and 15 in 28-day cycles.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
Treatment with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. | ||
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End point title |
Healing of osteolytic bone lesions on low dose CT [1] | ||||||
End point description |
lesions on low dose CT. Healing of osteolytic bone lesions on low dose CT. Healing will be evaluated based on the preexisting lesion on low dose CT required upon inclusion. All lesions will be evaluated individually using the inclusion scanning as reference. Healing will be defined as ≥ 25% reduction in the size of osteolytic lesions (a reduction of at least 2 mm in the longest dimension is required), increased sclerosis in the edge of existing lesions, or healing of existing lesions.
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End point type |
Primary
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End point timeframe |
from the inclusion in the protocol until the patient has been in the protocol for 24 months or until the patient leaves the protocol if that happens before 24 months
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| 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: For this primary end point there is no statistical analysis, as it is a count in the total group of patient treated. there is no control group. It is counts of lesion where healing is observed relative to baseline. |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were recorded from inclusion to 3 months after the last dose of ixazomib.
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Adverse event reporting additional description |
Patients were evaluated by a physician every 4 weeks in regards to multiple myeloma status, ECOG performance status, side effects, renal function, liver function, hematology, neuropathy etc. Adverse events were graded and recorded according to NCI CTC v. 4.0.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.0
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
All patient included and treated in the trial. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/36970780 |
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