A Phase II Study of ISABELA: Isatuximab, Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Massachusetts General Hospital
Summary
The main goal of this phase II study is to evaluate the overall response rate of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. The study drugs provided for research purposes are isatuximab and belantamab mafodotin.
Description
This is a phase II study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. Approximately 50 participants will take part in this research study. The primary objective is determining the overall response rate of the treatment. Treatment is until progression, adverse events, or withdrawal of consent.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix A). * Age ≥ 18 years * Measurable disease of multiple myeloma as defined by at least one of the following: * Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal pr…
Interventions
- DrugIsatuximab
An IgG1-derived monoclonal antibody that targets CD38 proteins, administered intravenously.
- DrugBelantamab mafodotin
An antibody-drug conjugate that is the combination of an antibody targeting BCMA and a drug, administered intravenously.
- DrugPomalidomide
An immunomodulatory agent, capsule taken orally.
- DrugDexamethasone
A glucocorticoid which is a substance that stops inflammation cause by immune system disorders, tablet taken orally.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts