Clinical Trials Register

Summary
EudraCT Number:	2020-004533-21
Sponsor's Protocol Code Number:	C1071003
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-05-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-004533-21

A.3

Full title of the trial

MAGNETISMM-3
AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 2 Study of Elranatamab (PF-06863135) Monotherapy in Participants With MM Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

A.4.1

Sponsor's protocol code number

C1071003

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04649359

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Pfizer Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pfizer, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer, Inc.
B.5.2	Functional name of contact point	ClinicalTrials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	66 Hudson Boulevard East
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10001
B.5.3.4	Country	United States
B.5.4	Telephone number	+1800 7181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/21/2471
D.3 Description of the IMP
D.3.1	Product name	PF-06863135
D.3.2	Product code	PF-06863135
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	elranatamab
D.3.9.2	Current sponsor code	PF-06863135
D.3.9.4	EV Substance Code	SUB201694
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

MULTIPLE MYELOMA

E.1.1.1

Medical condition in easily understood language

A hematological B-cell malignancy characterized by dysregulated proliferation of BM plasma cells.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10028228
E.1.2	Term	Multiple myeloma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the efficacy of elranatamab in patients with no prior BCMA therapy (Cohort A) and prior BCMA therapy (cohort B).

E.2.2

Secondary objectives of the trial

Key secondary:
- To determine additional efficacy of elranatamab in Cohort A

- To determine additional efficacy of elranatamab in Cohort A and Cohort B
- To determine the safety and tolerability of elranatamab
- To evaluate the PK of elranatamab
- To evaluate the immunogenicity of elranatamab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male or female participants age ≥18 years.
- A female participant is eligible to participate if she is not pregnant or breastfeeding. Within the Protocol, please refer to Appendix 4 for all reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
4. Measurable disease based on IMWG criteria as defined by at least 1 of the following:
a. Serum M-protein >0.5 g/dL by SPEP
b. Urinary M-protein excretion >200 mg/24 hours by UPEP
c. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum
immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
5. Refractory to at least one IMiD.
6. Refractory to at least one PI.
7. Refractory to at least one anti-CD38 antibody.
8. Relapsed or refractory to last anti-MM regimen.
Note: Refractory is defined as having disease progression while on therapy or within
60 days of last dose in any line, regardless of response.
9. Cohort A: Has not received prior BCMA-directed therapy.
Cohort B: Has received prior BCMA-directed ADC or BCMA-directed CAR T-cell
therapy, either approved or investigational.
10. ECOG performance status ≤2.
11. LVEF ≥40% as determined by a MUGA scan or ECHO.
12. Adequate hepatic function characterized by the following:
a. Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert’s syndrome);
b. AST ≤2.5 x ULN; and
c. ALT ≤2.5 x ULN
13. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
14. Adequate BM function characterized by the following:
a. ANC ≥1.0 × 10^9/L; (use of granulocyte-colony stimulating factors is permitted if completed at least 7 days prior to planned start of dosing)
b. Platelets ≥25 × 10^9/L; (transfusion support is permitted if completed at least 7 days prior to planned start of dosing)
c. Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least 7 days prior to planned start of dosing).
15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Informed Consent:
16. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Smoldering MM.
2. Active Plasma cell leukemia.
3. amyloidosis.
4. POEMS syndrome
5. Stem cell transplant within 12 weeks prior to enrollment or active GVHD.
6. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack,
cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
d. Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
7. Ongoing Grade ≥2 peripheral sensory or motor neuropathy
8. History of any grade peripheral sensory or motor neuropathy with prior BCMA directed therapy (Cohort B)
9. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
10. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.
11. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

12. Other surgical (including major surgery within 14 days prior to enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.

Prior/Concomitant Therapy:
13. Previous treatment with an anti-BCMA bispecific antibody.

Prior/Concurrent Clinical Study Experience:
14. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

Other Exclusions:
15. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
16. Known or suspected hypersensitivity to the study intervention or any of its excipients.
17. Live attenuated vaccine must not be administered within 4 weeks of the first dose of study intervention.

E.5 End points

E.5.1

Primary end point(s)

ORR by BICR per IMWG

E.5.1.1

Timepoint(s) of evaluation of this end point

In each of Cohort A and Cohort B, BOR will be assessed based on reported overall responses recorded at evaluation time points from the date of first dose until the first documentation of PD, death or start of new anticancer therapy, whichever occurs first.
- OR will encompass confirmed sCR, CR, VGPR and PR.

E.5.2

Secondary end point(s)

Key secondary:
- ORR by BICR baseline EMD status per IMWG

To determine additional efficacy of elranatamab in Cohort A and Cohort B:
- DOR by BICR and investigator per IMWG
- CRR by BICR and investigator per IMWG
- ORR by investigator per IMWG
- DOCR by BICR and investigator per IMWG
- PFS by BICR and investigator per IMWG
- OS
- TTR by BICR and investigator per IMWG
- MRD negativity rate (central lab) per IMWG

To determine the safety and tolerability of elranatamab
- AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.
- Severity of CRS and ICANS assessed according to ASTCT criteria (Lee et al, 2019).

To evaluate the PK of elranatamab
- Pre- and postdose concentrations of elranatamab

To evaluate the immunogenicity of elranatamab
- ADAs and NAbs against elranatamab

E.5.2.1

Timepoint(s) of evaluation of this end point

Analyses of secondary efficacy endpoints will use the Safety Analysis Set. Please refer to section 9.4.3 of the protocol for a complete description of each secondary endpoint.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Japan

United States

Belgium

France

Germany

Poland

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

180

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-20

P. End of Trial
P.	End of Trial Status	Trial now transitioned

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials