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Monoclonal Antibodies

Elranatamab Combinations for Multiple Myeloma (MAGNETISMM-5 Trial)

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
Must not have
Previous treatment with a BCMA-directed therapy.
Amyloidosis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new cancer treatment combination to see if it's more effective than the current standard of care for multiple myeloma.

Who is the study for?
This trial is for adults with multiple myeloma who've had prior treatments including lenalidomide and a proteasome inhibitor. They should have measurable disease, be in relatively good health (ECOG ≤2), not pregnant, and willing to use contraception. Excluded are those with certain other conditions like amyloidosis or active infections, previous BCMA therapy, recent stem cell transplant, or live vaccines taken within the last month.
What is being tested?
The study tests elranatamab alone or combined with daratumumab against a known combo of daratumumab, pomalidomide & dexamethasone in relapsed/refractory multiple myeloma patients. It's divided into parts: assessing safety and activity of different doses; comparing these treatments; evaluating alternative dosing schedules.
What are the potential side effects?
Potential side effects include reactions at the injection site, immune system-related issues such as inflammation in various organs due to antibody action, blood disorders from bone marrow suppression by chemotherapy drugs like dexamethasone and pomalidomide, infection risk increase due to immune modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with multiple myeloma.
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I have been treated for multiple myeloma with lenalidomide and a proteasome inhibitor.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a BCMA-targeted therapy before.
Select...
I have been diagnosed with amyloidosis.
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I do not have any active infections like HBV, HCV, HIV, or uncontrolled bacterial, fungal, or viral infections.
Select...
I have been diagnosed with POEMS Syndrome.
Select...
My condition is smoldering multiple myeloma.
Select...
I have been diagnosed with plasma cell leukemia.
Select...
I had a stem cell transplant less than 12 weeks ago or I have active graft versus host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 Randomized Arm B: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group II: Part 2 Randomized Arm A: ElranatamabExperimental Treatment1 Intervention
Group III: Part 1 Safety Lead-In Dose Escalation: Elranatamab + DaratumumabExperimental Treatment2 Interventions
Group IV: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + DexamethasoneActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elranatamab
2023
N/A
~1030
Daratumumab
2014
Completed Phase 3
~2380

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,660 Previous Clinical Trials
17,876,566 Total Patients Enrolled
41 Trials studying Multiple Myeloma
9,898 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,917,731 Total Patients Enrolled
29 Trials studying Multiple Myeloma
5,103 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05020236 — Phase 3
Multiple Myeloma Research Study Groups: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab, Part 2 Randomized Arm A: Elranatamab, Part 2 Randomized Arm B: Elranatamab + Daratumumab, Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05020236 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020236 — Phase 3
~135 spots leftby Aug 2025
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