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Monoclonal Antibody

Elranatamab + Daratumumab + Lenalidomide for Multiple Myeloma (MagnetisMM-6 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
ECOG performance status ≤2
Measurable disease based on IMWG criteria as defined by at least 1 of the following: Serum M-protein ≥0.5 g/dL, Urinary M-protein excretion ≥200 mg/24 hours, Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 73 months.
Awards & highlights

MagnetisMM-6 Trial Summary

This trial will examine if elranatamab, daratumumab and lenalidomide offer a better outcome than daratumumab, lenalidomide and dexamethasone in people with multiple myeloma.

Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who can't have a transplant, due to age or other health issues. It's also open to those who've had up to two prior treatments but haven't used certain myeloma drugs in the last six months. Participants should be able to perform daily activities with ease (ECOG ≤2) and not be pregnant.Check my eligibility
What is being tested?
Researchers are testing if Elranatamab combined with Daratumumab and Lenalidomide works better than the standard combo of Daratumumab, Lenalidomide, and Dexamethasone for multiple myeloma. The study has two parts: first finding a safe dose mix, then comparing how well each treatment prevents disease progression.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may cause organ inflammation, fatigue, blood disorders like anemia or clotting problems, infections due to lowered immunity, allergic reactions during infusion of the drugs, and potential harm to unborn babies.

MagnetisMM-6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My blood or urine tests show signs of my disease according to specific criteria.
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I have been diagnosed with multiple myeloma.

MagnetisMM-6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 73 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to 73 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 Dose Limiting Toxicity
Part 2: Progression free survival by blinded independent central review
Part 2: Sustained minimal residual disease negativity rate
Secondary outcome measures
Complete Response Rate
Duration of Complete Response
Duration of Response
+16 more

MagnetisMM-6 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Part 2 Randomized Arm A: Elranatamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions
Group II: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions
Group III: Part 1, Dose Level 1: Elranatamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions
Group IV: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + DexamethasoneActive Control3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elranatamab
2022
N/A
~510
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,060 Total Patients Enrolled
35 Trials studying Multiple Myeloma
8,924 Patients Enrolled for Multiple Myeloma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,255 Total Patients Enrolled
25 Trials studying Multiple Myeloma
4,234 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05623020 — Phase 3
Multiple Myeloma Research Study Groups: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone, Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide, Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide, Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05623020 — Phase 3
Daratumumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623020 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for individuals to partake in this experiment?

"As indicated by clinicaltrials.gov, this medical investigation is still conducting recruitment of patients. The trial was first made known on November 10th 2022 and the information has been updated as recently as March 22nd 2023."

Answered by AI

How many administrative centers are overseeing this research project?

"Presently, this clinical trial is taking place in 18 distinct sites scattered across Europe. These include Ostrava, Gdańsk and Brno as well as 15 other municipalities. For convenience's sake, it is best to select the site that is closest to you if you choose to participate."

Answered by AI

How many individuals are enrolled in this clinical experiment?

"To meet the study requirements, 676 individuals that qualify for inclusion must be recruited. Clinical trial sites include Fakultni nemocnice Ostrava in Ostrava, Moravskoslezský KRAJ and Uniwersyteckie Centrum Kliniczne in Gdańsk, Pomorskie."

Answered by AI

Is the combination of elranatamab, daratumumab and lenalidomide safe for trial participants?

"Thanks to evidence collected in Phase 3 trials, our team at Power has ranked Elranatamab + Daratumumab + Lenalidomide's safety a solid 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
2022. "A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05623020.
~644 spots leftby Mar 2028
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