A Study of Etentamig and Pomalidomide for Relapsed or Refractory Multiple Myeloma
This study is for adults with multiple myeloma (a type of blood cancer) that has come back or not responded to previous treatments (relapsed or refractory multiple myeloma). You may be eligible if you've had 1 to 3 prior treatments, including lenalidomide. Researchers are testing an investigational drug called etentamig, given by injection, in combination with oral pomalidomide. This combination will be compared to standard treatments like daratumumab, dexamethasone, and carfilzomib. The main goals are to see how safe the treatments are and how well they reduce cancer activity, specifically looking at complete response rates and how long people live without their disease getting worse. The study plans to enroll about 520 participants.
- Study design
- This is a randomized, open-label study, meaning participants are assigned to a treatment group by chance, and both you and your doctors will know which treatment you are receiving. It plans to enroll about 520 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and disease activity for up to approximately 75 months (about 6 years and 3 months).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
At a glance
Conditions
Where it's being run
66 sites across 51 statesStudy leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Safety Run-In: Number of Participants With Adverse Events (AE)sUp to Approximately 75 Months
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) AssessmentUp to Approximately 75 Months
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) AssessmentUp to Approximately 75 Months
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.