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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

224

Study ID:

NCT02874742

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

224

Study ID:

NCT02874742

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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