A Phase II Study of Daratumumab With Weekly Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Andrew Yee, MD
Summary
This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide
Description
This phase II, multicenter, open-label study is studying daratumumab in combination with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma who have received at least one prior therapy and who have had previous treatment with both lenalidomide and a proteasome inhibitor. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: *…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Men or women ≥ 18 and ≤ 80 years old * Diagnosis of multiple myeloma: * Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval * ≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis * Serum free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum free kappa to serum free kappa light chain ratio * Previously treated relapsed and refractory multiple myeloma * Patients must have received at least one prior line of therapy; * Prior therapy must include a…
Interventions
- DrugDaratumumab
predetermined dose, intravenously, at predetermined times per cycle
- DrugCarfilzomib
predetermined dose, intravenously, give 3 times per cycle
- DrugPomalidomide
predetermined dose, orally, daily per cycle
- DrugDexamethasone
predetermined dose, orally, given 8 times per cycle
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts