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Clinical Trial 19230
Cancer Type: Malignant Hematology
Interventions:Bortezomib; CC-5013 (Lenalidomide); Daratumumab; Dexamethasone; Lenalidomide (Revlimid); PS-341 (Bortezomib); Velcade (Bortezomib)
Study Type: Treatment
Phase of Study: Phase II
- Kenneth Shain
Phase 2, Randomized, Open-Label Study Comparing Daratumumab, Lenalidomide, Bortezomib,and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma Eligible for High-Dose Chemotherapy and Autologous Stem Cell Transplantation
This research study for participants with newly diagnosed Multiple Myeloma is looking at the safety and effectiveness of a study drug, Daratumumab, when added to a standard of care treatment, Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) alone.
Primary Objective: The primary objective is to determine if the addition of daratumumab to lenalidomide, bortezomib, and dexamethasone (D-RVd) will increase the proportion of subjects achieving stringent complete response (sCR), as defined by the International Myeloma Working Group (IMWG) criteria, by the time of completion of post-autologous stem cell transplantation (ASCT) consolidation treatment, compared with RVd alone. Secondary Objectives: To evaluate complete response (CR) and sCR rate following induction, ASCT, post-ASCT consolidation, and maintenance treatment. To evaluate overall response rate (ORR) and rate of very good partial response (VGPR) or better following induction, ASCT, post-ASCT consolidation, and maintenance treatment. To evaluate duration of and time to sCR and time to CR. To evaluate time to VGPR or better. To evaluate time to partial response (PR) or better. To assess negative minimal residual disease (MRD) rate following induction, ASCT, post-ASCT.consolidation, and maintenance treatment. To evaluate clinical outcomes including: Time to progression (TTP); Progression-free survival (PFS); Overall survival (OS); Duration of response. To assess the safety and tolerability of D-RVd. To assess the pharmacokinetics of daratumumab. To assess the immunogenicity of daratumumab JNJ-54767414 (daratumumab) To evaluate patient-reported outcomes (PROs). To evaluate stem cell yield after mobilization. To assess time to engraftment, defined as absolute neutrophil count >1.0 x 10^9/L and platelet count >100 x 10^9/L. Exploratory Objectives: To evaluate PFS on next-line therapy. To evaluate the clinical efficacy of D-RVd in high-risk cytogenetic subgroups: del(1p), gain of 1q, del(17p), t(4;14), t(14;16), t(14;20). To explore immune modulatory effects of D-RVd as compared with RVd through immune profiling (NK, T, and B cells) and T-cell receptor sequencing. To collect medical resource utilization (MRU) data that may be used in future economic modeling (the construction and reporting of the economic model will be conducted separately from this study).