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Multiple MyelomaCancerDrugPhase 3

What this study is

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.

What's being tested

  • Elranatamab

    Intervention · DRUG

    Elranatamab will be administered subcutaneously

  • Elotuzumab

    Intervention · DRUG

    Elotuzumab will be administered intravenously

  • Pomalidomide

    Intervention · DRUG

    Pomalidomide will be administered orally

  • Dexamethasone

    Intervention · DRUG

    Dexamethasone will be administered orally

  • Bortezomib

    Intervention · DRUG

    Bortezomib will be administered subcutaneously or intravenously

  • Carfilzomib

    Intervention · DRUG

    Carfilzomib will be administered intravenously

Study details

Official 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
Sponsor
Pfizer
Conditions
Multiple Myeloma
Enrolling
492 people
Starts
2024-02-08
Est. completion
2027-12-30
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗