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Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM

Study acronym: HO147SMM
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 1, 2023 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 2025 to Aug 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 120 to confirmed 58 · Completion date: Oct 2025 to Dec 2028 · 1 morev10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 58
    • Completion date: Oct 2025 to Dec 2028
    • Site details revised at 16 of 16 sites
  2. 2 versions Re-verified since Mar 22, 2022, no change to tracked fieldsv8-v9
  3. Study sites: 1 to 16v7
  4. Re-verified, no change to tracked fieldsv6
  5. Study sites: 17 to 1v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 17 Eligibility criteria shortened, about 41 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2018 to Nov 19, 2018v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2018 to Nov 19, 2018
  3. Start date: Sep 2018 to Nov 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized (2:1) multi-center open-label phase II trial. Patients with high-risk SMM will be enrolled on the study and treated with KRd combination (Cycles 1-9 carfilzomib 20/36 mg/m2, lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9) or Rd combination (Cycles 1-9 lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9); followed by extended lenalidomide dosing (10 mg days 1-21 of a 28 day cycle for 24 cycles).
Trial Details
NCT Number NCT03673826
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions Smouldering Myeloma
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov