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DREAMM 7: Evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma

Description

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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to compare the efficacy of belantamab mafodotin in combination with bortezomib and dexamethasone (bor/dex) with that of daratumumab in combination with bor/dex in participants with relapsed/refractory multiple myeloma (RRMM).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet the following 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

Excluding patients who meet the following 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
     

Accepting new patients

 

Learn more at

clinicaltrials.gov