What's the purpose of this trial?

The purpose of the study is to evaluate whether elranatamab in combination with daratumumab and lenalidomide (EDR) can provide superior clinical benefit compared to control therapy with daratumumab, lenalidomide and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are transplant ineligible or transplant-deferred.

This is an upcoming trial that has not yet started accepting patients.

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What will happen during the trial?

This study is being conducted in two parts. Part 1 explored several doses of daratumumab and lenalidomide (standard treatments for multiple myeloma) given alongside the study medicine elranatamab. The results from Part 1 were used to select the doses for the next part of the study – Part 1 is no longer enrolling participants. In Part 2, researchers will use the best dose/dosing schedule from Part 1 and compare the safety and effectiveness of Elranatamab combined with Daratumumab and Lenalidomide against the combination of Daratumumab, Lenalidomide and Dexamethasone. 

This study is open-label, which means that both researchers and participants will know which groups the participants have been placed in, and which treatments they will receive. Participants may continue to receive treatment as long as they don’t experience unacceptable side effects and their myeloma doesn’t get worse. During the first week of participation in the clinical trial, participants will need to be hospitalized for a minimum of 2 days when they receive their first dose of Elranatamab. Depending on how the patient responds, additional hospitalization during the second dose may be required as well. 

 

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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Additional Trial Information

Phase 3

Enrollment: 1,116 patients (estimated)

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