Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Arm A: Belantamab Mafodotin — DRUG
  1.9 milligram/kilogram (mg/kg) intravenous (IV) will be administered every 8 weeks for first 24 weeks (Cycles 1-3), then 1.9 mg/kg every 12 weeks (Cycles 4+) until progression, unacceptable toxicity or participant withdrawal
• Arm B: Daratumumab Hyaluronidase — DRUG
  1800 mg subcutaneous (SC) will be administered weekly from Week 1-8 (Cycles 1 and 2), every 2 weeks from Week 9-24 (Cycles 3-6), and every 4 weeks from Week 25 (Cycles 7+) onwards until progression, unacceptable toxicity or participant withdrawal
• Bortezomib — DRUG
  1.3 milligrams per square meter (mg /m²) SC on days 1, 8 and 15 of every 28 day bortezomib treatment cycle for 8 cycles
• Lenalidomide — DRUG
  25 mg orally (PO) Days 1-21 of every 28 day lenalidomide treatment cycle.
• Dexamethasone — DRUG
  40 mg PO on Days 1, 8, 15, and 22 of each 28-day cycle (may decrease to 20 mg if \>75 years old)

Study Details

Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent. Belantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells. Minimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer. The purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.

Key Dates

First listed

Dec 16, 2025

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Nov 30, 2031

Completion

Jun 30, 2034

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Belantamab Mafodotin
  Belantamab mafodotin in combination with bortezomib, lenalidomide and dexamethasone (VRd) until progression, unacceptable toxicity or participant withdrawal. 1 cycle = 28 days.
• Active Comparator: Arm B:
  Daratumumab in combination with bortezomib, lenalidomide and dexamethasone (VRd) until progression, unacceptable toxicity or participant withdrawal. 1 cycle = 28 days.

Primary Outcome Measure

MRD Negative Status [ Time Frame: Up to 86 months ]

Central Contacts

• Michael Wright, MS
  267-319-3910
  [email protected]

Locations (1)

Find similar trials in La Crosse, WI

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