Belantamab Mafodotin or Daratumumab for Multiple Myeloma
(PrE1005 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Belantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.
Minimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.
The purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.
Who Is on the Research Team?
Shaji Kumar, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults (18+) with newly diagnosed multiple myeloma who have not had more than one cycle of treatment and are either not eligible or choose to delay a bone marrow transplant. Participants must have measurable disease and be able to give informed consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Belantamab Mafodotin
- Bortezomib
- Daratumumab Hyaluronidase
- Dexamethasone
- Lenalidomide
Trial Overview
The study compares two drug combinations: one group gets belantamab mafodotin with bortezomib, lenalidomide, and dexamethasone; the other gets daratumumab hyaluronidase with the same three drugs. Treatment continues until the cancer worsens or side effects become too severe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Belantamab mafodotin in combination with bortezomib, lenalidomide and dexamethasone (VRd) until progression, unacceptable toxicity or participant withdrawal. 1 cycle = 28 days.
Daratumumab in combination with bortezomib, lenalidomide and dexamethasone (VRd) until progression, unacceptable toxicity or participant withdrawal. 1 cycle = 28 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PrECOG, LLC.
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
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