Evaluating the Safety and Effectiveness of Multiple Drug Combinations for Adults with Multiple Myeloma in a Flexible Platform Study

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior in the body of various treatment combinations used alone or together in adults with multiple myeloma, a type of blood cancer. This flexible platform study allows new treatment groups to open as new therapies become available. Two substudies focus on different treatment combinations one with cevostamab and lenalidomide as maintenance after transplant in high-risk patients, and another with cevostamab and iberdomide in patients with relapsed or refractory disease who have had multiple prior treatments. In the first substudy, participants receive cevostamab intravenously with step-up doses followed by regular doses on a 28-day cycle combined with oral lenalidomide on days 1 to 21 of each cycle. The second substudy administers cevostamab intravenously every 3 weeks with oral iberdomide on days 1 to 14 of a 21-day cycle. Additional drugs like dexamethasone and tocilizumab may be used as needed. Each substudy has a dose escalation phase followed by a dose expansion phase, with specific dosing schedules maintained throughout. Participants will be regularly assessed through various tests and procedures to monitor side effects, treatment response, and disease progression over a period of up to about five years. Researchers will measure outcomes like adverse events, response rates, survival times, and drug levels in the body. Participants agree to follow scheduled assessments, and safety monitoring includes managing potential complications such as cytokine release syndrome. The study aims to gather long-term data on these treatment combinations impact on multiple myeloma.

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma