Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 t...
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 dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Tracking Information
- NCT #
- NCT04508790
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Michael A Rosenzweig City of Hope Medical Center
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