A Phase IB, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
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Study Summary
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.
The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.
To evaluate the safety and tolerability of cemsidomide and dexamethasone in combination with a BCMA BiTE for the treatment of multiple myeloma To evaluate the safety and tolerability of cemsidomide, an IKZF1/3 degrader, and dexamethasone in combination with elranatamab as a second line or later therapy for patients with multiple myeloma. To evaluate cemsidomide in combination with elranatamab in the hopes we can develop a new treatment regimen and potentially improve outcomes for multiple myeloma patients in earlier lines of therapy.
To evaluate the safety, tolerability and preliminary efficacy of cemsidomide in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader.
To establish an optimal dose for cemsidomide in combination with elranatamab by evaluating the safety and tolerability as well as preliminary anti-myeloma activity of cemsidomide in combination with elranatamab in RRMM patients.
To evaluate cemsidomide in combination with elranatamab, beginning at the 75 µg dose of cemsidomide with the opportunity to explore 50 µg and 100 µg doses of cemsidomide.
- * Diagnosis of multiple myeloma as defined by IMWG criteria Measurable disease based on IMWG criteria Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader) ECOG performance status 0-2
- Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Participants with any active, uncontrolled bacterial, fungal, or viral infection
- Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
- Administration with an investigational product within 30 days preceding the first dose of study intervention
- Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Clinical Study Information for Healthcare Providers
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