A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma
City of Hope Medical Center
Summary
This phase II trial studies how well leflunomide, pomalidomide, and dexamethasone work for the treatment of multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Leflunomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with pomalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as dexamethasone, 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. Giving leflunomide with pomalidomide and dexamethasone may work better in treating multiple myeloma compared to pomalidomide and dexamethasone alone.
Description
PRIMARY OBJECTIVE: I. To estimate the response rate and to evaluate the antitumor activity of the three-drug combination, leflunomide, pomalidomide, and dexamethasone, in patients with relapsed/refractory multiple myeloma. SECONDARY OBJECTIVES: I. To characterize and evaluate toxicities, including type, frequency, severity, attribution, time course, and duration. II. To obtain estimates of response duration, depth of response, clinical benefit, and survival (overall and progression-free). OUTLINE: Patients receive leflunomide orally (PO) on days 1-28, pomalidomide PO on days 1-21, and de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Life expectancy \> 3 months * Diagnosis of multiple myeloma with measurable disease as defined by: * M-protein quantities \>= 0.5 g/dL by serum protein electrophoresis (sPEP) or * \…
Interventions
- DrugDexamethasone
Given PO
- DrugLeflunomide
Given PO
- DrugPomalidomide
Given PO
Locations (8)
- City of Hope Medical CenterDuarte, California
- City of Hope at SeacliffHuntington Beach, California
- City of Hope at Antelope ValleyLancaster, California
- City of Hope at Long Beach ElmLong Beach, California
- City of Hope at Newport Beach Fashion IslandNewport Beach, California
- City of Hope at South PasadenaSouth Pasadena, California