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Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 29 to 31
  2. Study sites: 28 to 29
    • Eligibility criteria expanded, about 17 words
  3. Site contacts updated at 1 of 28 sitesv23
  4. Site details revised at 1 of 28 sitesv22
  5. Study sites: 26 to 28v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study title expanded, about 1 wordv20
  2. Re-verified, no change to tracked fieldsv19
  3. Site contacts updated at 1 of 26 sitesv18
  4. Enrollment target: 559 to 570v17 Show 5 more changesShow less
    • Interventions: Daratumumab (Drug), Dexamethasone (Drug), Lenalidomide (Drug) to Daratumumab (Drug), Dexamethasone (Drug), Isatuximab (Drug), Lenalidomide (Drug)
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised at 1 of 26 sites
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 4 words
  5. Site contacts updated at 1 of 26 sitesv16
  6. Study sites: 25 to 26v15
  7. Study sites: 24 to 25v14
  8. Study sites: 22 to 24v13
  9. Study sites: 20 to 22v12
  10. Study sites: 18 to 20v11
  11. Study sites: 15 to 18v10
  12. Study sites: 12 to 15v9
  13. Re-verified, no change to tracked fieldsv8
  14. Study sites: 11 to 12v7
  15. Site details revised at 1 of 11 sitesv6
  16. Study sites: 9 to 11v5
  17. Study sites: 1 to 9v4
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 30, 2024 to Apr 10, 2024
    v3
  19. Start date: Feb 28, 2024 to Apr 30, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?
Trial Details
NCT Number NCT06182774
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Canadian Institutes of Health Research (CIHR), Myeloma Canada
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 570 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov