Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM (NCT07150104)
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 7 - Belantamab Mafodotin, Nirogacestat, Pomalidomide, and Dexamethasone in Combination
🩺 Plain-English Summary (8th-Grade Level)
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, pomalidomide, and dexamethasone and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (25 items).
Location: GSK Investigational Site — Salvador, Estado de Bahia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with current corneal epithelial disease except mild punctate keratopathy.
- Participants with evidence of cardiovascular risk.
- Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
- Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
- Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days.
- Participants with prior radiotherapy within 2 weeks of start of study therapy.
- Participants with prior allogeneic transplant are prohibited.
- Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
- Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
- Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
- Participants with \>=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- GSK Investigational Site — Salvador, Estado de Bahia
- GSK Investigational Site — Porto Alegre, Rio Grande do Sul
- GSK Investigational Site — Halifax, Nova Scotia
- GSK Investigational Site — Villejuif,
- GSK Investigational Site — Mexico City,
- GSK Investigational Site — Oslo,
- GSK Investigational Site — Lublin,
- GSK Investigational Site — Seoul,
- GSK Investigational Site — Ulsan,
- GSK Investigational Site — Falun,
💰 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.
More studies in Multiple Myeloma
- Registry for Adults With Plasma Cell Disorders (PCD's) — Chapel Hill, North Carolina
- A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma — Mobile, Alabama
- A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events — San Francisco, California
- A Multicenter Prospective Observational Cohort Study Evaluating the Impact of Cancer-Directed Treatment and Medication Use, Including Cannabis Use, in Multiple Myeloma Patients — Goodyear, Arizona
- Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study) — Miami, Florida
- Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma — La Crosse, Wisconsin
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.