Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma (NCT04091126)
A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Westwood, Kansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (30 Sites)
Showing the first 25 of 30 sites.
- GSK Investigational Site — Westwood, Kansas
- GSK Investigational Site — Charlotte, North Carolina
- GSK Investigational Site — Madison, Wisconsin
- GSK Investigational Site — Newcastle, New South Wales
- GSK Investigational Site — Clayton, Victoria
- GSK Investigational Site — Fitzroy, Victoria
- GSK Investigational Site — Edmonton, Alberta
- GSK Investigational Site — London, Ontario
- GSK Investigational Site — Poitiers,
- GSK Investigational Site — Dresden,
- GSK Investigational Site — Hamburg,
- GSK Investigational Site — Schwerin,
- GSK Investigational Site — Tübingen,
- GSK Investigational Site — Bologna,
- GSK Investigational Site — Meldola FC,
- GSK Investigational Site — Lublin,
- GSK Investigational Site — Poznan,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Badalona,
- GSK Investigational Site — Barcelona,
- GSK Investigational Site — Madrid,
- GSK Investigational Site — Málaga,
- GSK Investigational Site — PamplonaNavarra,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant — Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb — Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma — Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma — Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.