Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma
Yale University
Summary
The purpose of this research study is to determine if two drugs approved for treating multiple myeloma, belantamab mafodotin and elotuzumab, are safe and more effective when used together.
Description
Patients with RR MM beyond two-three lines of therapy have inferior outcomes. They have to cycle through the available lines of treatment options and ultimately succumb to progressive disease. Despite improvements in modern treatments this subset of MM patients has a grim prognosis and thus represent a population with unmet need. Hence, further advances in combination therapies are required. MM is associated with both qualitative and quantitative T cell dysfunction owing to variety of mechanisms including increased expression of inhibitory immune checkpoint molecules. Elotuzumab enhances NK ce…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy. Relapsed/refractory disease as defined by IMWG criteria. 2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Participant must be ≥ 18 years of age 4. Prior line of therapy must include iMID, proteasome inhibitor, and anti-CD38 monoclonal antibody. Prior elotuzumab is allowed. 5. Participant must have adequate organ function, defined as: * ANC ≥0.5X 10 9/L * Hemoglobin ≥8.0 g/dL * Platelets ≥50X 10 9/L * Total…
Interventions
- DrugElotuzumab
Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days.
- DrugBelantamab mafodotin
Belantamab mafodotin will be administered via IV infusion on day 1 of each 28 day cycle. There will be 3 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested, further dose reduction to 1.4mg/kg every 8 weeks will be administered. Following the dose evaluation, there will be a dose expansion cohort wtih 12 additional subjects. There is no dose escalation planned in this study.
Location
- Yale New Haven HospitalNew Haven, Connecticut