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Brief Title: Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
Official Title: 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
Study ID: NCT02874742
Brief Summary: The purpose of this study is to determine if the addition of daratumumab to lenalidomide-bortezomib-dexamethasone (RVd) will increase the proportion of participants 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Duarte, California, United States
, La Jolla, California, United States
, Los Angeles, California, United States
, San Francisco, California, United States
, Aurora, Colorado, United States
, Washington, District of Columbia, United States
, Orlando, Florida, United States
, Tampa, Florida, United States
, Atlanta, Georgia, United States
, Chicago, Illinois, United States
, Westwood, Kansas, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Worcester, Massachusetts, United States
, Detroit, Michigan, United States
, Saint Louis, Missouri, United States
, Omaha, Nebraska, United States
, Buffalo, New York, United States
, New York, New York, United States
, Chapel Hill, North Carolina, United States
, Charlotte, North Carolina, United States
, Durham, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Columbus, Ohio, United States
, Portland, Oregon, United States
, Abington, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Nashville, Tennessee, United States
, Dallas, Texas, United States
, Houston, Texas, United States
, Salt Lake City, Utah, United States
, Seattle, Washington, United States
, Spokane, Washington, United States
, Milwaukee, Wisconsin, United States
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR