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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IKZF1/3 degrader
• BCMA-CD3 bispecific antibody
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
NOT_YET_RECRUITINGUCLA Health, Jonsson Comprehensive Cancer Center
Santa Monica, California, United States
NOT_YET_RECRUITINGWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGNorton Cancer Institute St. Matthews
Louisville, Kentucky, United States
NOT_YET_RECRUITINGUniversity of Maryland Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, United States
NOT_YET_RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
NOT_YET_RECRUITINGDuke Cancer Center
Durham, North Carolina, United States
NOT_YET_RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
NOT_YET_RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
NOT_YET_RECRUITING...and 2 more locations
Safety and tolerability of cemsidomide in combination with elranatamab
Dose limiting toxicity rate
Time frame: Cycle 1 approximately 28 days
Safety and tolerability of cemsidomide in combination with elranatamab
Frequency and severity of AEs
Time frame: Baseline through 30 days after discontinuation of study treatment
Assess antimyeloma activity
Objective Response Rate (ORR) per IMWG criteria
Time frame: Approximately 2 years
Evaluate the PK of cemsidomide and elranatamab
Pre and post dose concentrations of cemsidomide
Time frame: Approximately 4 months
Evaluate the PK of cemsidomide and elranatamab
Pre dose concentrations of elranatamab
Time frame: Approximately 2 years
Assess the immunogenicity of elranatamab
Percent of participants with positive anti-drug antibodies to elranatamab
Time frame: Approximately 2 years
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