MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of

(1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone.

Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).

- 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.

- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).

- Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.

- ECOG performance status ≤2.

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

- Not pregnant and willing to use contraception.

Exclusion Criteria:

- Smoldering multiple myeloma.

- Plasma cell leukemia.

- Amyloidosis.

- POEMS Syndrome.

- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.

- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.

- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

- Previous treatment with a BCMA-directed therapy.

- Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.

- Live attenuated vaccine within 4 weeks of the first dose of study intervention.

- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05020236
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab

Experimental: Part 2 Randomized Arm A: Elranatamab

Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab

Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone

Interventions

Drug: - Elranatamab

subcutaneous

Drug: - Daratumumab

Daratumumab / hyaluronidase, subcutaneous

Drug: - Pomalidomide

oral

Drug: - Dexamethasone

oral

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clovis Community Medical Center, Clovis, California

Status

Active, not recruiting

Address

Clovis Community Medical Center

Clovis, California, 93611

Site Contact

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