Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02874742

CR108195

54767414MMY2004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Daratumumab+Lenalidomide+Bortezomib+Dexamethasone (D-RVd)

Experimental group

Description:

Participants will receive lenalidomide, bortezomib, dexamethasone and daratumumab.

Treatment:

Drug: Daratumumab

Drug: Dexamethasone

Drug: Bortezomib

Drug: Lenalidomide

Lenalidomide+Bortezomib+Dexamethasone (RVd)

Experimental group

Description:

Participants will receive lenalidomide, bortezomib and dexamethasone.

Treatment:

Drug: Dexamethasone

Drug: Bortezomib

Drug: Lenalidomide