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.
Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
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
Sequential
Cemsidomide
DrugIKZF1/3 degrader
Elranatamab
Biological/Vaccine• BCMA-CD3 bispecific antibody
Safety and tolerability of cemsidomide in combination with elranatamab
Dose limiting toxicity rate
Safety and tolerability of cemsidomide in combination with elranatamab
Frequency and severity of AEs
Assess antimyeloma activity
Objective Response Rate (ORR) per IMWG criteria
Evaluate the PK of cemsidomide and elranatamab
Pre and post dose concentrations of cemsidomide
Evaluate the PK of cemsidomide and elranatamab
Pre dose concentrations of elranatamab
Assess the immunogenicity of elranatamab
Percent of participants with positive anti-drug antibodies to elranatamab
Click on the lead sponsor to view all of their trials.
