Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design.

Abstract

Belantamab mafodotin (belamaf) is a BCMA-targeted antibody-drug conjugate recently approved as monotherapy for adults with relapsed/refractory multiple myeloma who have received ≥4 prior therapies. Belamaf binds to BCMA and eliminates myeloma cells by multimodal mechanisms of action. The cytotoxic and potential immunomodulatory properties of belamaf have led to novel combination studies with other anticancer therapies. Here, we describe the rationale and design of DREAMM-5, an ongoing Phase I/II platform study evaluating the safety and efficacy of belamaf combined with novel agents, including GSK3174998 (OX40 agonist), feladilimab (an ICOS; GSK3359609), nirogacestat (a gamma-secretase inhibitor; PF-03084014) and dostarlimab (a PD-1 blocker) versus belamaf monotherapy for patients with relapsed/refractory multiple myeloma. Clinical trial registration: NCT04126200 (ClinicalTrials.gov).

• Authors: Ajay K Nooka, Katja Weisel, Niels Wcj van de Donk, David Routledge, Paula Rodriguez Otero, Kevin Song, Hang Quach, Natalie Callander, Monique C Minnema, Suzanne Trudel, Nicola A Jackson, Christoph M Ahlers, Ellie Im, Shinta Cheng, L Smith, Nahi Hareth, Geraldine Ferron-Brady, Maria Brouch, Rocio Montes de Oca, Sofia Paul, Beata Holkova, Ira Gupta, Brandon E Kremer, Paul Richardson
• Journal: Future oncology (London, England) (Future Oncol) Vol. 17 Issue 16 Pg. 1987-2003 (06 2021) ISSN: 1744-8301 [Electronic] England
• PMID: 33682447 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• Antibodies, Monoclonal, Humanized
• B-Cell Maturation Antigen
• Receptors, OX40
• TNFRSF17 protein, human
• TNFRSF4 protein, human
• Tetrahydronaphthalenes
• dostarlimab
• belantamab mafodotin
• Valine
• nirogacestat

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• B-Cell Maturation Antigen (antagonists & inhibitors)
• Clinical Trials, Phase I as Topic
• Clinical Trials, Phase II as Topic
• Drug Resistance, Neoplasm
• Female
• Humans
• Male
• Middle Aged
• Multicenter Studies as Topic
• Multiple Myeloma (drug therapy, immunology, pathology)
• Neoplasm Recurrence, Local (drug therapy, immunology, pathology)
• Randomized Controlled Trials as Topic
• Receptors, OX40 (antagonists & inhibitors)
• Research Design (standards)
• Tetrahydronaphthalenes (administration & dosage)
• Valine (administration & dosage, analogs & derivatives)
• Young Adult