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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Smoldering multiple myeloma.

Plasma cell leukemia.

Amyloidosis.

Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

492 Participants
are divided into 2 treatment groups
Group A: ElranatamabExperimental treatment 1 intervention
Group B: Investigator's ChoiceActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression free survival per International Myeloma Working Group criteria

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

Time frame
Up to approximately 5 years

Secondary outcomes

1

Overall survival

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

Time frame
Up to approximately 5 years
2

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

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

Time frame
Up to approximately 5 years
3

Objective response rate per International Myeloma Working Group criteria

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

Time frame
Up to approximately 5 years
4

Duration of response per International Myeloma Working Group criteria

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

Time frame
Up to approximately 5 years

Other outcomes

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