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Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor 2 versions Re-verified since May 19, 2026, no change to tracked fieldsv16-v17
  2. Notable Results first posted: May 20, 2026
    • Secondary endpoints revised (11)
    • Primary endpoint revised
    v15
  3. Minor 3 versions Re-verified since Apr 23, 2025, no change to tracked fieldsv12-v14
  4. Notable Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: Dec 12, 2028 to Jun 18, 2025
    • Enrollment target: estimated 5 to confirmed 6
    • Study completion date: Mar 19, 2031 to Mar 26, 2028
    v11
  5. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Financial issuesv10 Show 4 more changesShow less
    • Enrollment target: 49 to 5
    • Study sites: 3 to 2
    • Primary completion date: Dec 28, 2028 to Dec 12, 2028
    • Study completion date: Dec 28, 2028 to Mar 19, 2031
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Eligibility criteria shortened, about 28 wordsv9
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Minor Start date: Dec 10, 2023 to Dec 5, 2023v7
  4. Minor Site details revised at 2 of 3 sitesv6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2023 to Dec 10, 2023
    • Site details revised at 3 of 3 sites
    v5
  6. Notable Start date: Jul 30, 2023 to Dec 30, 2023v4
  7. Notable Start date: Jun 30, 2023 to Jul 30, 2023v3
  8. Minor Site contacts updated at 1 of 3 sitesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Trial Details
NCT Number NCT05911321
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Genzyme, a Sanofi Company
Conditions
(from sponsor)
Multiple Myeloma, Relapse, Refractory, Aging, Co-morbidity
Related terms Multiple Myeloma, Recurrence
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov