Phase 2 Study of Leflunomide Combined with Pomalidomide and Dexamethasone for Treating Relapsed or Resistant Multiple Myeloma

What this Trial Is About

Researchers are evaluating the combination of leflunomide, pomalidomide, and dexamethasone for treating relapsed or refractory multiple myeloma, a type of cancer that affects plasma cells. This phase II clinical trial aims to estimate the response rate and assess the antitumor activity of this three-drug regimen. Leflunomide may block enzymes needed for cancer cell growth, pomalidomide may modify the immune system to interfere with tumor growth, and dexamethasone is a chemotherapy drug that may stop cancer cells from growing or spreading. Participants receive leflunomide orally every day for 28 days, pomalidomide orally for the first 21 days, and dexamethasone orally on days 1, 8, 15, and 22 of each 28-day cycle. Treatment cycles repeat every 28 days as long as the disease does not progress and side effects remain acceptable. After finishing the treatment, patients are followed up 30 days later and then every three months to monitor their condition. During the study, participants will have regular evaluations to measure overall response to treatment, side effects, response duration, depth of response, clinical benefit, survival, and minimal residual disease status, all assessed up to one year. Safety will be monitored for 30 days after the last dose. The study involves oral medication and periodic follow-up visits over the course of treatment and observation periods.

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma