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NCT Number: NCT06152575

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).

This study is seeking participants who:

* Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment.

Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.

Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.

The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:

* a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.

Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).

The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

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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

Instituto Alexander Fleming, Ciudad Autónoma de Buenos Aires, 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 International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
  • Measurable disease defined as 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 involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Have clinical laboratory values within the specified range.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  • Not pregnant or breastfeeding and willing to use contraception.

Exclusion criteria

  • Smoldering multiple myeloma.
  • Plasma cell leukemia.
  • Amyloidosis.
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
  • Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
  • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
  • Unable to receive investigator's choice therapy.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.

Treatment and study plan

Elranatamab

Drug

Elranatamab will be administered subcutaneously

Elotuzumab

Drug

Elotuzumab will be administered intravenously

Pomalidomide

Drug

Pomalidomide will be administered orally

Dexamethasone

Drug

Dexamethasone will be administered orally

bortezomib

Drug

Bortezomib will be administered subcutaneously or intravenously

Carfilzomib

Drug

Carfilzomib will be administered intravenously

Primary outcomes

  1. Progression free survival per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

Secondary outcomes

  1. Overall survival

    Time frame: Up to approximately 5 years

    From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first

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

    Time frame: Up to approximately 5 years

    From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first

  3. Objective response rate per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy

  4. Duration of response per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

  5. Very good partial response or better response rate per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

  6. Complete response rate per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

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

    Time frame: Up to approximately 5 years

    From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

  8. Time to response per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of randomization to date of confirmed objective response

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

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

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

    Time frame: Up to approximately 5 years

    From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first

  11. Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria

    Time frame: Up to approximately 5 years

    From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first

  12. Frequency of treatment-emergent adverse events

    Time frame: From date of first dose of study intervention up to 90 days after last study intervention administration

  13. Frequency of abnormal laboratory results

    Time frame: From date of first dose of study intervention up to 90 days after last study intervention administration

  14. Free elranatamab serum trough concentration [Ctrough]

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

  15. Elranatamab immunogenicity by anti-drug antibodies against elranatamab

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

  16. 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 up to approximately 35 days after last administration of study intervention

    Change from baseline scores

  17. 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 up to approximately 35 days after last administration of study intervention

    Change from baseline scores

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

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Jul 9, 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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