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DARA RVD For High Risk SMM

Study acronym: PRISM
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 20, 2026 to Dec 20, 2027v13
  2. Re-verified, no change to tracked fieldsv12
  3. Primary completion date: Mar 8, 2026 to Dec 20, 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Mar 8, 2029 to Dec 8, 2030 · Site details revised at 6 of 6 sitesv11 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Mar 8, 2029 to Dec 8, 2030
    • Site details revised at 6 of 6 sites
  4. Enrollment target: 60 to 61 Site contacts updated at 2 of 6 sites · Collaborator revisedv10 Show 2 more changesShow less
    • Site contacts updated at 2 of 6 sites
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 5 to 6v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Study sites: 2 to 5v7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Feb 1, 2026 to Mar 8, 2026 Completion date: Feb 1, 2026 to Mar 8, 2029 · Start date: Apr 9, 2021 to Mar 8, 2021v5 Show 2 more changesShow less
    • Completion date: Feb 1, 2026 to Mar 8, 2029
    • Start date: Apr 9, 2021 to Mar 8, 2021
  5. Lead sponsor: Omar Nadeem to Omar Nadeem, MD Enrollment target: 30 to 60 · Primary completion date: Feb 1, 2023 to Feb 1, 2026v4 Show 2 more changesShow less
    • Enrollment target: 30 to 60
    • Primary completion date: Feb 1, 2023 to Feb 1, 2026
  6. Re-verified, no change to tracked fieldsv3
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2021 to Apr 9, 2021 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2021 to Apr 9, 2021
    • Site details revised at 2 of 2 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: * Daratumumab (also called Darzalex Faspro) * Bortezomib (also called Velcade) * Lenalidomide (also called Revlimid) * Dexamethasone
Trial Details
NCT Number NCT04775550
Lead Sponsor Omar Nadeem, MD
Collaborators: Janssen Pharmaceuticals
Conditions High-risk Smoldering Multiple Myeloma, Multiple Myeloma
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov