Phase 3 Study Comparing Fixed Duration Versus Continuous Anti-CD38 Antibody Treatment in Older Adults With Newly Diagnosed Multiple Myeloma Who Are Not Eligible for Transplant

What this Trial Is About

Researchers are studying whether stopping daratumumab or isatuximab treatment after about a year and a half is as effective as continuing these treatments without stopping in older adults newly diagnosed with multiple myeloma who are not eligible for stem cell transplant. This trial compares fixed duration therapy versus continuous therapy alongside lenalidomide and dexamethasone, with some participants also receiving bortezomib. The study is a Phase III randomized trial designed to answer if less anti-CD38 antibody treatment works as well as ongoing treatment. Participants are randomly assigned to one of two groups. In the usual care group, patients continue all their current myeloma medications including daratumumab or isatuximab injections. In the experimental group, patients stop the daratumumab or isatuximab injections but continue taking lenalidomide and dexamethasone tablets. Treatment continues indefinitely as long as patients benefit from it. Doses for daratumumab, isatuximab, lenalidomide, and dexamethasone are determined when participants enroll. During the study, participants will be monitored for how long they live without their disease worsening, overall survival, response to treatment, side effects, time until next treatment, and quality of life using questionnaires. Researchers will also assess treatment-related side effects and economic outcomes over about 9 years. Participants must complete quality of life and health utility questionnaires in English, French, or validated languages and will be followed regularly to assess these outcomes and safety over the course of the study.

Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma