At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of multiple myeloma per IMWG criteria with ≥10% monoclonal plasma cells in bone marrow or biopsy-proven plasmacytoma AND at least one CRAB criterion (hypercalcemia, renal insufficiency, anemia, or bone lesions) OR biomarker of malignancy (clonal BM plasma cells ≥60%, involved/uninvolved FLC ratio ≥100, or >1 focal MRI lesion)
- ✓Measurable disease by central laboratory assessment
- ✓ECOG performance status 0, 1, or 2
- ✓Women of childbearing potential must have negative pregnancy tests within 10-14 days and within 24 hours prior to dosing
- ✕Prior therapy for multiple myeloma except short course corticosteroids (≤40 mg dexamethasone or equivalent daily, total ≤160 mg)
- ✕Frailty index ≥2 per Myeloma Geriatric Assessment
- ✕Prior or concurrent invasive malignancy (other than MM) within 5 years, with exceptions for adequately treated basal/squamous cell skin cancer, cervical/breast carcinoma in situ, or other non-invasive lesions
- ✕Peripheral neuropathy or neuropathic pain Grade 2 or higher (NCI-CTCAE v5)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
In Brief
A Phase 3 clinical trial evaluating Daratumumab, Bortezomib, and 2 other interventions for Multiple Myeloma. Completed, enrolled 395 participants across 114 sites in 13 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Participants will receive bortezomib 1.3 milligram per square meter (mg/m\^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity. Participants aged greater than (\>)75 years or body mass index (BMI) less than (\<) 18.5 kilograms per meters (kg/m\^2) will receive dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle.
Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m\^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity. Participants aged \>75 years or BMI \<18.5 kg/m\^2 will receive Dexamethasone 20 mg oral tablets on Days 1, 4, 8, and 11 of each cycle.
Interventions
Daratumumab (1800 mg) will be administered by SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3-8. For Cycle 9 and beyond, participants will receive daratumumab 1800 mg SC once every 4 weeks until documented disease progression or unacceptable toxicity.
Bortezomib 1.3 mg/m\^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.