Phase III study of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) versus Daratumumab, Bortezomib, and Dexamethasone (D-Vd) in participants with Relapsed/Refractory Multiple Myeloma

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Overview

This clinical trial is testing how effective the combination of Belantamab Mafodotin, Bortezomib and Dexamethasone is when compared to the combination of Daratumumab, Bortezomib and Dexamethasone in the treatment of relapsed/refractory multiple myeloma.

SparkCures ID 1082
Trial Phase Phase 3
Enrollment 575 Patients
Treatments
Tags
Trial Sponsors
  • GlaxoSmithKline
NCT Identifier

NCT04246047

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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;
    1. Urine M-protein excretion >=200 mg per 24-hour, or
    2. Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
    3. 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.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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