Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase II
Principal Investigator: Shain, Kenneth
A Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients with Newly-Diagnosed Multiple Myeloma (ADVANCE)
This study is being done to find out whether carfilzomib, lenalidomide, and dexamethasone (KRD) or KRD and Daratumumab (KRD+DARA) might be safer and more effective ways of controlling multiple myeloma than the stand or care treatment, which is lenalidomide, bortezomib, and dexamethasone (VRD).
1. To compare the rates of MRD negativity for patients who receive VRD (Arm A) to patients who receive KRD (Arm B) and for patients who receive VRD (Arm A) to patients who received DKRd (Arm C); 2. To compare overall survival, progression-free survival, and event-free survival in patients achieving PR or less within the first 4 cycles of therapy, across the treatment arms (Arm A vs Arm B, Arm A vs Arm C); 3. To compare the rates of PR or better, VGPR or better, CR and sCR across the treatment arms (Arm A vs Arm B, Arm A vs Arm C); 4. To compare the rate of MRD-negativity as a best response after the completion of eight cycles of therapy across the treatment arms (Arm A vs Arm B, Arm A vs Arm C); 5. To compare the safety and tolerability of the three treatment arms; 6. To compare MRD assessments in bone marrow versus blood with different techniques.
Chemotherapy (NOS); Immunotherapy
Bortezomib (); CC-5013 (Lenalidomide); Daratumumab (Darzalex); Dexamethasone (); Lenalidomide (Revlimid); PS-341 (Bortezomib); Velcade (Bortezomib); carfilzomib (Kyprolis)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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