A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.

Key facts

Study ID

NCT03652064

Run by

Janssen Research & Development, LLC

People needed

395

Starts

2018-11-06

Expected to finish

2026-04-21

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.
• Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies
• Must have measurable disease, as assessed by central laboratory
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen

You may not qualify if…

• Frailty index of >=2 according to Myeloma Geriatric Assessment score
• Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day, total of 160 mg dexamethasone or equivalent)
• Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
• Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
• Focal radiation therapy within 14 days of randomization with the exception of palliative radiotherapy for symptomatic pain management. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management

Where it is running

• Baptist MD Anderson — Jacksonville, Florida, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Cancer And Hematology Centers of Western Michigan PC — Grand Rapids, Michigan, United States
• Saint Lukes Hospital Saint Lukes Cancer Specialists — Kansas City, Missouri, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYU Winthrop — Mineola, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Good Samaritan Hospital Corvallis — Corvallis, Oregon, United States
• University Of Pittsburgh Medical Center UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Gibbs Cancer Center — Spartanburg, South Carolina, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Universidade Estadual De Campinas — Campinas, Brazil
• Liga Norte Riograndense Contra O Cancer — Natal, Brazil
• Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS — Porto Alegre, Brazil
• Ministerio da Saude Instituto Nacional do Cancer — Rio de Janeiro, Brazil
• Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) — Rio de Janeiro, Brazil
• Instituto de Ensino e Pesquisa São Lucas — São Paulo, Brazil
• Innovative Clinical Research Inc — Cerritos, California, United States

Full record on ClinicalTrials.gov

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