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A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Feb 2027 → Feb 2028
See other at-risk trials from Hackensack Meridian Health

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Feb 2027 to Feb 2028 Show 5 more changesShow less
    • Recruitment resumed after suspension
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 6 of 12 entries
  2. Primary and study completion dates: Jan 2026 to Feb 2027v8
  3. Trial status: Recruiting to Suspended Sponsor's reason: Enrollment is paused pending an upcoming amendment
    • Primary and study completion dates: Jan 2025 to Jan 2026
    • Site details revised at 2 of 2 sites
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary and study completion dates: Jan 2024 to Jan 2025
    • Site contacts updated at 1 of 2 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jan 2023 to Jan 2024
    • Site contacts updated at 1 of 2 sites
    v4
  2. Study sites: 1 to 2
    • Study completion date: Jan 2023 to Jan 2024
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2020 to Mar 16, 2021
    • Secondary endpoints revised (5)
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, 2-arm (with an additional exploratory arm), open-label, multicenter study looking at the response rate of patients receiving selinexor (KPT-330), in combination with carfilzomib, daratumumab or pomalidomide. Multiple Myeloma patients with documented disease progression or refractory disease while on current treatment with any carfilzomib-containing regimen (arm 1), any pomalidomide-containing regimen (arm 2) or any daratumumab-containing regimen (exploratory arm) will be included in the study. Patients will be assigned to the respective groups according to their current treatment. If a subject has received more than one of the above therapies, then assignment will be made at their physician's discretion (e.g treatment decision can be made based upon patient and physician preferred tolerance.). Patients will receive treatment until progressive disease (PD), death, toxicity that cannot be managed by standard of care, or withdrawal, whichever occurs first.
Trial Details
NCT Number NCT04661137
Lead Sponsor Hackensack Meridian Health
Collaborators: Karyopharm Therapeutics Inc
Conditions
(from sponsor)		 Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov