Triple Drug Therapy for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use other anti-myeloma therapies besides leflunomide, pomalidomide, and dexamethasone. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination of Dexamethasone, Leflunomide, and Pomalidomide for treating multiple myeloma?
Research shows that the combination of pomalidomide and low-dose dexamethasone is effective for patients with relapsed and refractory multiple myeloma, improving survival and response rates compared to high-dose dexamethasone alone. This suggests that pomalidomide and dexamethasone are effective components in treating this condition.12345
Is the triple drug therapy for multiple myeloma safe for humans?
The combination of pomalidomide and low-dose dexamethasone has been shown to have a manageable safety profile in patients with relapsed and refractory multiple myeloma. Common side effects include neutropenia (low white blood cell count), infections, anemia (low red blood cell count), and thrombocytopenia (low platelet count), but these were generally manageable.12567
What makes the triple drug therapy for multiple myeloma unique?
This triple drug therapy combines Dexamethasone, Leflunomide, and Pomalidomide, offering a novel approach by using Leflunomide's unique ability to inhibit immune cell proliferation, which is not commonly used in multiple myeloma treatments. This combination may provide a new mechanism of action compared to standard therapies.89101112
Research Team
Michael A. Rosenzweig
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. They must have had at least one prior therapy, be in relatively good health (ECOG <=2), and not planning a transplant soon. Participants need measurable levels of cancer markers in their blood/urine and adequate organ function. Women of childbearing age must test negative for pregnancy and agree to birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive leflunomide, pomalidomide, and dexamethasone in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexamethasone
- Leflunomide
- Pomalidomide
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator