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Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Not specified to Phase 4v2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 45 to 59
    • Primary completion date: Sep 2027 to Nov 30, 2027
    • Study completion date: Dec 2027 to Dec 31, 2027
    • Start date changed from estimate of May 2024 to Jun 12, 2024
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)
Trial Details
NCT Number NCT06409702
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions
(from sponsor)		 Newly Diagnosed, High Risk, MRD, Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov