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Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Mar 1, 2026 to May 28, 2033
    • Study completion date: Mar 1, 2031 to May 28, 2033
    v17
  2. Eligibility criteria shortened, about 3 wordsv16
  3. Site contacts updated at 3 of 5 sitesv15
  4. Study sites: 3 to 5v14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Site details revised at 2 of 3 sitesv12
  2. 2 versions Re-verified since Jun 30, 2023, no change to tracked fieldsv10-v11
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 18, 2022 to Feb 18, 2022
    • Site details revised at 3 of 3 sites
    v9
  4. Start date: May 18, 2022 to Jun 18, 2022v8
  5. Start date: Apr 18, 2022 to May 18, 2022v7
  6. Start date: Mar 24, 2022 to Apr 18, 2022v6
  7. Start date: Feb 24, 2022 to Mar 24, 2022
    • Site contacts updated at 1 of 3 sites
    v5
  8. Site contacts updated at 1 of 3 sitesv4
  9. Re-verified, no change to tracked fieldsv3
  10. Start date: Dec 30, 2021 to Feb 24, 2022
    • Primary completion date: Dec 2026 to Mar 1, 2026
    • Study completion date: Dec 2029 to Mar 1, 2031
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.
Trial Details
NCT Number NCT05145400
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Multiple Myeloma, Cancer
Related terms Multiple Myeloma, Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov