Skip to main content

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed / Refractory Multiple Myeloma

Trial Status: Active

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib / dexamethasone (Arm A) versus daratumumab in combination with bortezomib / dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

Inclusion Criteria

  • Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
  • Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Must have at least 1 aspect of measurable disease, defined as one of the following;
  • Urine M-protein excretion >=200 mg per 24-hour, or
  • Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
  • Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.
  • Adequate organ function

Exclusion Criteria

  • Intolerant to daratumumab.
  • Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
  • Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
  • Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
  • Prior allogenic stem cell transplant.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
  • Corneal epithelial disease.

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: APPROVED

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: WITHDRAWN

Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd).

Treatment will continue in both arms until progressive disease, death, unacceptable toxicity,

withdrawal of consent or end of study, whichever occurs first.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
GlaxoSmithKline

  • Primary ID 207503
  • Secondary IDs NCI-2020-02880
  • Clinicaltrials.gov ID NCT04246047