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OncoMatch/Clinical Trials/NCT04508790

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

Is NCT04508790 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dexamethasone and Leflunomide for recurrent plasma cell myeloma.

Phase 2RecruitingCity of Hope Medical CenterNCT04508790Data as of May 2026

Treatment: Dexamethasone · Leflunomide · PomalidomideThis 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: proteasome inhibitor

Relapsed or refractory to at least 1 prior line of therapy, including both a proteasome inhibitor and an immunomodulatory drug

Must have received: immunomodulatory drug

Relapsed or refractory to at least 1 prior line of therapy, including both a proteasome inhibitor and an immunomodulatory drug

Cannot have received: leflunomide

Prior treatment with leflunomide

Cannot have received: allogeneic transplant

Prior allogeneic transplant

Lab requirements

Blood counts

ANC >= 1.0 x 10^9/L (independent of G-CSF/GM-CSF for at least 1 week, pegylated G-CSF for at least 2 weeks); Platelets >= 75.0 x 10^9/L (independent of platelet transfusions for at least 2 weeks); Hemoglobin >= 8.0 g/dL (transfusion support allowed)

Kidney function

Creatinine clearance of >= 30 mL/min per 24 hour urine test

Liver function

Total bilirubin <= 2 X ULN (unless has Gilbert's disease); AST <= 3.5 x ULN; ALT <= 3.5 x ULN; Alkaline phosphatase < 5 x ULN

ANC >= 1.0 x 10^9/L... Platelets >= 75.0 x 10^9/L... Hemoglobin >= 8.0 g/dL... Total bilirubin <= 2 X ULN (unless has Gilbert's disease)... AST <= 3.5 x ULN... ALT <= 3.5 x ULN... Alkaline phosphatase < 5 x ULN... Creatinine clearance of >= 30 mL/min per 24 hour urine test

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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