Study on Leflunomide, Pomalidomide, and Dexamethasone for Treating Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04508790

Provider View

This clinical trial is testing a combination of three drugs—leflunomide, pomalidomide, and dexamethasone—to see if they can better treat multiple myeloma that has returned or is not responding to other treatments.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—leflunomide, pomalidomide, and dexamethasone—works in treating multiple myeloma that has come back or is not responding to treatment. Leflunomide may help stop cancer cells from growing by blocking certain enzymes. Pomalidomide may boost the immune system to fight cancer, and dexamethasone is a chemotherapy drug that can kill cancer cells or stop them from spreading. The study aims to find out if using all three drugs together is more effective than using pomalidomide and dexamethasone alone.

Description

The main goal of this study is to see how well the combination of leflunomide, pomalidomide, and dexamethasone works in patients with relapsed or hard-to-treat multiple myeloma. Researchers will also look at the side effects of the treatment and how long the benefits last.

Participants will take leflunomide by mouth every day for 28 days, pomalidomide by mouth for 21 days, and dexamethasone by mouth on specific days each month. This cycle will repeat every 28 days as long as the treatment is working and side effects are manageable.

After finishing the treatment, participants will have follow-up visits 30 days later and then every three months to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Agree to allow the use of previous tumor biopsy samples, if available.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 3 months.
  • Have a diagnosis of multiple myeloma with measurable disease.
  • Have tried at least one previous treatment that included a proteasome inhibitor and an immunomodulatory drug, and are not eligible for a transplant.
  • Have recovered from previous cancer treatment side effects to a mild level.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for four weeks after the last dose.
  • Men must agree to use effective birth control or abstain from sex during the study and for four weeks after the last dose.

Exclusion Criteria

  • Have previously been treated with leflunomide.
  • Are resistant to pomalidomide, meaning the cancer progressed during or shortly after treatment with pomalidomide alone or in combination.
  • Are planning to use other treatments for multiple myeloma besides the study drugs.
  • Have had an allogeneic transplant.
  • Have allergies to similar drugs used in the study.
  • Test positive for tuberculosis or hepatitis A, B, or C.
  • Have HIV.
  • Have a history of rheumatoid arthritis.
  • Have an active infection requiring treatment within two weeks before joining the study.
  • Have had severe allergic reactions to similar drugs.
  • Have had other cancers in the past three years, except for certain skin cancers or in situ cancers that have been successfully treated.
  • Are pregnant or breastfeeding.
  • Have any other condition that might make participating in the study unsafe.
  • May not be able to follow the study procedures according to the investigator's judgment.

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