A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

An Open-Label, 3-Arm, Multicenter, Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy Including Lenalidomide and a Proteasome Inhibitor - MAGNETISMM-5

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210098

Enrollment

944

Registered

2021-11-02

Start date

2022-01-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed/refractory multiple myeloma

Interventions

Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab Part 2 Arm A: Elranatamab Arm B: Elranatamab + Daratumumab Arm C: Daratumumab + Pomalidomide + Dexamethasone Part 3 Arm D: Elranat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1.Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014). 2. Measurable disease based on IMWG criteria as defined by at least 1 of the following: a.Serum M-protein >=0.5 g/dL. b.Urinary M-protein excretion >=200 mg/24 hours. c.Serum immunoglobulin FLC >=10 mg/dL (>=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (1.65). 3.Prior anti-multiple myeloma therapy including treatment with lenalidomide. 4.ECOG performance status <=2. 5.Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade <=1. 6.Not pregnant and willing to use contraception.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Smoldering multiple myeloma. 2.Plasma cell leukemia. 3.Amyloidosis. 4.POEMS Syndrome. 5.Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease. 6.Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. 7.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. 8.Previous treatment with a BCMA-directed therapy. 9.Live attenuated vaccine within 4 weeks of the first dose of study intervention. 10.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.

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures : Part 1 Safety Lead-In: Incidence of dose limiting toxicities [Time Frame: First 42 days after first elranatamab dose] Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months] Part 3: Frequency of treatment-emergent adverse events [Time Frame: First 84 days after first elranatamab dose]	—

Measure

Time frame

Primary Outcome Measures : Part 1 Safety Lead-In: Incidence of dose limiting toxicities [Time Frame: First 42 days after first elranatamab dose] Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months] Part 3: Frequency of treatment-emergent adverse events [Time Frame: First 84 days after first elranatamab dose]

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026