Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In
Emory University
Summary
This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving belantamab mafodotin, pomalidomide, and dexamethasone may kill more cancer cells.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of belantamab mafodotin, pomalidomide and dexamethasone (BPd) by assessing the \>= complete response (CR) rates with BPd maintenance in patients with high-risk myeloma by International Myeloma Working Group (IMWG) criteria. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of BPd in patients with high-risk myeloma. II. To determine the antitumor activity of BPd maintenance among high-risk myeloma patients. TERTIARY/EXPLORATORY OBJECTIVE: I. To evaluate the changes in microenvironment among…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Transplant-eligible myeloma patient that has undergone autologous stem cell transplant (ASCT) within one year of their diagnosis and has achieved \>= partial response (PR) based on IMWG standard criteria. Patients will be enrolled within day 60-100 after ASCT * Patient's with high-risk disease defined as * Presence of del(17p); t(4;14); t(14;16); t(14;20) by fluorescence in situ hybridization (FISH) or by cytogenetics (CTG) * Plasma cell leukemia at diagnosis with \>= 20% circulating plasma cells on peripheral blood * Participant must have an Eastern Cooperative Onc…
Interventions
- BiologicalBelantamab Mafodotin
Given IV
- DrugDexamethasone
Given PO
- DrugPomalidomide
Given PO
Location
- Emory University/Winship Cancer InstituteAtlanta, Georgia