A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant

Study acronym: KRdvsRd
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Jan 1, 2026 → Sep 1, 2027
See other at-risk trials from Fondazione EMN Italy Onlus

Record History

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  1. Primary and study completion pushed from Jan 1, 2026 to Sep 1, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 5 of 11 entries
    • Site details revised at 2 of 40 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jul 1, 2024 to Jan 1, 2026v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 340 to confirmed 84
    • Study sites: 42 to 40
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study sites: 1 to 42v2
  6. Study First Submitted
  • 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 combination of lenalidomide plus low-dose dexamethasone (Rd) is considered the new standard for elderly newly diagnosed multiple myeloma (NDMM) patients. The combination carfilzomib plus lenalidomide-dexamethasone (KRd) in relapsed-refractory MM patients improved the progression-free survival (PFS) of approximately 1 year compared to standard Rd treatment. In a small phase 2 trial (23 pts) the KRd combination in elderly NDMM pts showed a complete response (CR) rate of 79% and a PFS at 3 years of 80%. Cardiovascular adverse events are the most limiting toxicities, especially in elderly patients.
Trial Details
NCT Number NCT04096066
Lead Sponsor Fondazione EMN Italy Onlus
Conditions
(from sponsor)		 Multiple Myeloma, New Diagnosis Tumor
Related terms Multiple Myeloma
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov