drugset / Trial / NCT05231629

Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

NCT05231629

RandomizedSequentialOpen-labelTreatment

Summary

This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.

Timeline

Start
2023-12-13
Primary completion
2027-12
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified
Comparator Melphalan Small molecule
Subject Teclistamab Monoclonal antibody
Background Bortezomib Small molecule
Background Daratumumab Monoclonal antibody
Background Dexamethasone Small molecule

Indications