What we are studying
This research study for patients with newly diagnosed Multiple Myeloma is looking at the safety and effectiveness of a drug, Daratumumab, when added to a standard of care treatment, Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) alone.
The study is being done primarily to look at whether or not adding daratumumab to standard of care treatment — Revlimid® (lenalidomide), Velcade® (bortezomib), and dexamethasone (RVd) — will help patients with newly diagnosed Multiple Myeloma achieve a better response after receiving treatment with RVd, with or without daratumumab, and an autologous stem cell transplant (ASCT). A better response is a treatment outcome where there are ? 5% plasma cells in the bone marrow and no evidence of myeloma proteins in your serum or urine by lab testing. The study will examine whether adding daratumumab to RVd treatment affects the effectiveness of treatment, compared to RVd alone.
Other assessments of daratumumab study treatment will also be performed, such as the safety and tolerability of the drug, how the drug is used by the body (pharmacokinetics), how the body’s immune system responds to the drug (immunogenicity), and how patients feel while taking the drug (patient reported outcomes, or PRO).