Study of Early Versus Standard Treatment for Relapse in Multiple Myeloma Patients After First Line Therapy with Stem Cell Transplant

What this Trial Is About

Researchers are evaluating whether treating minimal residual disease MRD relapse earlier, after first line treatment for multiple myeloma, can prolong progression-free survival and overall survival compared to treating relapse at progressive disease. This study focuses on patients who become MRD negative after standard first line treatment including autologous stem cell transplantation, aiming to form a uniform group for comparison. The trial is conducted in phases II and III to assess these outcomes over many years. Participants with newly diagnosed multiple myeloma eligible for high-dose therapy will first receive standard Norwegian care bortezomib, lenalidomide, and dexamethasone in 21-day cycles, with four cycles before and after transplant. After induction, patients undergo single or tandem autologous stem cell transplant ASCT based on response and toxicity. Those achieving MRD negativity post consolidation will be randomly assigned to start second-line treatment either at MRD relapse arm A or at progressive disease arm B. Both groups receive the same 28-day cycle treatment of carfilzomib, dexamethasone, and daratumumab until progression, unacceptable side effects, or withdrawal. During the study, patients will have regular MRD assessments every four months in arm A and standard follow-up in arm B, with additional MRD checks scheduled at specific timepoints during second-line treatment. Researchers will measure progression-free survival, overall survival, MRD negativity rates, time to next treatment, and quality of life over 10 to 11 years. Participants will be closely monitored for safety and treatment response throughout their participation, which can last many years depending on outcomes.

The Relapse from MRD Negativity As Indication for Treatment (REMNANT) Study