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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04508790
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Given PO
  • Leflunomide — DRUG
    Given PO
  • Pomalidomide — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Nov 24, 2020
Status verified
May 2026
Primary completion
Feb 14, 2027
Completion
Feb 14, 2027

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (leflunomide, pomalidomide, dexamethasone)
    Patients receive leflunomide 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.

Primary Outcome Measure

Overall response [ Time Frame: Up to 1 year ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Michael A. Rosenzweig
[email protected]
626-256-4973
Michael A. Rosenzweig (PRINCIPAL_INVESTIGATOR)
City of Hope at SeacliffHuntington BeachCalifornia92648
Michael Rosenzweig
[email protected]
626-218-4673
City of Hope at Antelope ValleyLancasterCalifornia93534
Michael Rosenzweig
[email protected]
626-218-4673
City of Hope at Long Beach ElmLong BeachCalifornia90813
Michael Rosenzweig
[email protected]
626-218-4673
City of Hope at Newport Beach Fashion IslandNewport BeachCalifornia92660
Michael Rosenzweig
[email protected]
626-218-4673
City of Hope at South PasadenaSouth PasadenaCalifornia91030
MIchael mic Rosenzweig
[email protected]
6262184673
City of Hope at South BayTorranceCalifornia90503
Michael Rosenzweig
[email protected]
626-218-4673
City of Hope at UplandUplandCalifornia91786
MIchael Rosenzweig
[email protected]
626-218-4673

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City of Hope Medical Center· Duarte, CACity of Hope at Seacliff· Huntington Beach, CACity of Hope at Antelope Valley· Lancaster, CACity of Hope at Long Beach Elm· Long Beach, CACity of Hope at Newport Beach Fashion Island· Newport Beach, CACity of Hope at South Pasadena· South Pasadena, CA

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