Multiple Myeloma Clinical Trial
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
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.
Eligibility Criteria
Inclusion Criteria:
Considered by the investigator to be eligible for high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT) according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory studies
Has not had prior systemic therapy for multiple myeloma. An emergency course of steroids (defined as no greater than 40 milligram [mg] of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. In addition, radiation therapy is permitted prior to study entry, during screening, and during Cycles 1-2 of study treatment as needed for lytic bone disease
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Woman of childbearing potential must have 2 negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) during screening, the first one within 10 to 14 days prior to the first dose of any component of study treatment and the second within 24 hours prior to the first dose of any component of study treatment
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (including during dose interruptions), and for 4 weeks following discontinuation of lenalidomide, and if receiving daratumumab, for 3 months after the last dose
Exclusion Criteria:
Diagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy treated with curative intent and with no known active disease present for more than equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies (including but not limited to, cervical, breast) with no evidence of disease
Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma
Known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) less than (<)50 percent (%) of predicted normal
Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C. Participants who completed treatment for hepatitis C at least 6 months prior to screening and have no detectable circulating hepatitis C virus (HCV) at screening, may participate in the study. Such participants will be required to undergo regular assessment for HCV reactivation during their participation in the study. Participants who test positive for HCV at any time during these assessments will be withdrawn from the study
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There is 1 Location for this study
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
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