Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide.
Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide.
Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
Adequate organ function and performance status
Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
Known central nervous system involvement of MM
Known history of other active malignancies within the past 3 years (with specific exceptions)
Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)
Parallel
Etentamig
DrugInjection
Pomalidomide
DrugOral
Daratumumab
DrugInjection
Dexamethasone
DrugOral or Injection
Carfilzomib
DrugInjection
Teclistamab
DrugInjection
Safety Run-In: Number of Participants With Adverse Events (AE)s
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment
CR or better is defined as proportion of participants with best overall response (BOR) of CR or stringent CR (sCR) as assessed per International Myeloma Working Group (IMWG) 2016 criteria. CR is defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and less than 5% plasma cells in bone marrow aspirates. The treatment effect will be summarized as the difference in the CR or better rates between etentamig in combination with pomalidomide and standard available therapies (SAT).
Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment
PFS is defined as duration from the date of randomization to the date of disease progression assessed according to the IMWG (2016) response criteria, per IRC assessment or death due to any cause, whichever occurs first.
Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment
BOR is defined as the best response achieved across all response assessments, partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR), from randomization until disease progression per investigator assessment, using IMWG (2016) response criteria.
Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig
Cmax of Etentamig.
Safety Run-In: Time to Cmax (Tmax) of Etentamig
Cmax of Etentamig.
Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig
Cmax of Etentamig.
This trial is not recruiting at the moment. You can still explore other options:
