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NCT04508790

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 12 versions: 11 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 9 words
    • Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised at 8 of 8 sites
  2. Start date: Nov 27, 2020 to Nov 24, 2020
    • Site contacts updated at 6 of 8 sites
    v11
  3. Study sites: 1 to 8v10
  4. Primary and study completion dates: Jun 30, 2024 to Feb 14, 2027v8
  5. Primary and study completion dates: Jun 30, 2023 to Jun 30, 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Nov 1, 2023 to Jun 30, 2023v6
  2. Primary and study completion dates: Nov 1, 2021 to Nov 1, 2023v5
  3. Start date changed from estimate of Oct 15, 2020 to Nov 27, 2020v4
  4. Start date: Oct 1, 2020 to Oct 15, 2020v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2020 to Oct 1, 2020
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall response
Timeframe: Up to 1 year

Secondary (6)

Incidence of adverse events
Response duration
Depth of response
Clinical benefit response
Overall survival
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Minimal residual disease (MRD) status

Arms and interventions

Treatment (leflunomide, pomalidomide, dexamethasone)Experimental

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.

Drugs: Dexamethasone, Leflunomide, Pomalidomide

Sites

8 sites in 1 country