A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Conditions

• Multiple Myeloma
• Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belantamab mafodotin — DRUG
  Belantamab mafodotin will be administered.
• Lenalidomide — DRUG
  Lenalidomide will be administered.
• Dexamethasone — DRUG
  Dexamethasone will be administered.
• Daratumumab — DRUG
  Daratumumab will be administered.

Study Details

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

Key Dates

Start date

Dec 16, 2024

Status verified

Apr 2026

Primary completion

Apr 28, 2031

Completion

Apr 28, 2031

Study Design

Enrollment

520 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone
  Belantamab mafodotin, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
• Active Comparator: Arm B: Daratumumab + Lenalidomide + Dexamethasone
  Daratumumab, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Primary Outcome Measure

PFS [ Time Frame: Up to approximately 7 years ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (30)

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