Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible patients will be randomised 1:1 into Arm A or Arm B of the study. Patients enrolled in Arm A will receive Belantamab mafodotin in combination with Bortezomib plus Dexamethasone. Patients enrolled in Arm B will Daratumumab in combination with Bortezomib plus Dexamethasone.
Conditions
This trial is treating people with multiple myeloma
Eligibility
Exclusion
- 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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
GlaxoSmithKline
Scientific Title
A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
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