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NCT Number: NCT05020236

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

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide 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 evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.

Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.

All people participating in 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Austral, Presidente Derqui, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.

Treatment and study plan

Elranatamab

Drug

subcutaneous

Other names: PF-06863135

Daratumumab

Drug

Daratumumab / hyaluronidase, subcutaneous

Other names: Darzalex Faspro; Darzalex solution for injection

Pomalidomide

Drug

oral

Other names: Pomalyst, Imnovid

Dexamethasone

Drug

oral

Primary outcomes

  1. Part 1 Safety Lead-In: Incidence of dose limiting toxicities

    Time frame: First 42 days after first elranatamab dose

  2. 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

  3. Part 3: Frequency of treatment-emergent adverse events

    Time frame: First 84 days after first elranatamab dose

Secondary outcomes

  1. Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  2. Overall survival

    Time frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  3. Objective response rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  4. Duration of response per International Myeloma Working Group criteria

    Time frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  5. Time to response per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of confirmed objective response, assessed up to 51 months

  6. Complete response rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  7. Duration of complete response per International Myeloma Working Group criteria

    Time frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months

  8. Minimal residual disease negativity rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  9. Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months

  10. Progression free survival on next-line treatment per International Myeloma Working Group criteria

    Time frame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months

  11. Frequency of treatment-emergent adverse events

    Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.

  12. Frequency of abnormal laboratory results

    Time frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.

  13. Rate of Grade ≥2 cytokine release syndrome

    Time frame: First 28 days after first elranatamab dose

  14. Elranatamab pharmacokinetics by pre- and post-dose concentrations

    Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab

  15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab

    Time frame: From date of first dose through up to 14 days after date of last dose of elranatamab

  16. Daratumumab pharmacokinetics by pre-dose concentrations

    Time frame: From date of first dose through up to 14 days after date of last dose of daratumumab

  17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

    Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention

  18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

    Time frame: From date of informed consent through up to 35 days after date of last dose of study intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: MAGNETISMM-5

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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