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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 according to the IMWG criteria.
  • 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.

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: IN_REVIEW

Washington

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Status: WITHDRAWN

Approximately 478 patients 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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
GlaxoSmithKline

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