What's the purpose of this trial?
The goal of this clinical trial is to better understand which dose of investigational drug cemsidomide in combination with elranatamab may be best tolerated and most effective at treating relapsed or refractory multiple myeloma. Researchers also hope to better understand how the body processes the study drugs and how they function in the body.
This trial is currently open and accepting patients.
What will happen during the trial?
In this study, all participants will receive cemsidomide, elranatamab and dexamethasone in cycles. Each cycle in this study will be 28 days (4 weeks). Depending on when a participant joins the study, they may be placed in one of two different groups (or cohorts): dose escalation or dose expansion. Participants in the dose escalation cohort will receive one of three different planned doses of cemsidomide. Participants in the dose expansion cohort will receive the selected doses of cemsidomide found to be the most safe and tolerable in the dose escalation cohort.
Elranatamab will be administered by injection under the skin (called subcutaneous injection). Participants will receive smaller doses of elranatamab at first, called step-up doses. The first 2 step-up doses will require overnight hospitalization, 48 hours for the first step-up dose and 24 hours for the second step-up dose. Once the step-up dosing period has completed and participants tolerate it, participants will receive elranatamab twice a month for 3 cycles and then monthly thereafter in combination with cemsidomide. Cemsidomide will be taken by mouth once a day for 14 days and then no cemsidomide will be taken for the next 14 days. Dexamethasone will be taken by mouth for the first 4 cycles on days 1, 8, 15 and 22 of each 28 day cycle or until a response to treatment is observed, whichever occurs first.
Participants may continue receiving study treatment until their multiple myeloma gets worse, they have side effects they cannot tolerate, they choose to withdraw from the study, or the study is stopped.
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.
- are willing and able to comply with all study visits and study procedures.
- have measurable disease as defined by the trial criteria.
- have received at least 2 but no more than 4 prior lines of therapy which must have included an immunomodulatory drug for at least 2 consecutive cycles (for inclusion in dose escalation cohort).
- have received at least 1 but no more than 3 prior lines of therapy which must have included an immunomodulatory drug for at least 2 consecutive cycles (for inclusion in the dose expansion cohort).
- have not had a stem cell transplant in the three months prior to enrollment.
- have not had prior treatment with mezigdomide or iberdomide during the most recent line of therapy.
- have not had prior treatment with a BCMA-directed T-Cell engager (e.g. Teclistamab or Elranatamab) or BCMA directed CAR-T therapy.
Additional Trial Information
Phase 1
Enrollment: 60 patients (estimated)
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