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A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 35 words Site details revised at 9 of 16 sites · Publications: details revised at 1 of 1 entry Show 2 more changesShow less
    • Site details revised at 9 of 16 sites
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 17 to 16v17
  3. Study sites: 16 to 17v16
  4. Primary completion date: Jun 30, 2024 to Jan 2028 Enrollment target: 141 to 127 · Completion date: Jun 30, 2025 to Jan 2028 · Interventions: Bortezomib (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Dexamethasone (Drug), Selinexor (Drug) · 5 morev15 Show 8 more changesShow less
    • Enrollment target: 141 to 127
    • Completion date: Jun 30, 2025 to Jan 2028
    • Interventions: Bortezomib (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Selinexor (Drug) to Bortezomib (Drug), Dexamethasone (Drug), Selinexor (Drug)
    • Eligibility criteria shortened, about 135 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 13 of 16 sites
    • Study title shortened, about 10 words
    • Study arms: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 2 of 16 sitesv14
Show 12 earlier versionsHide 12 earlier versions
  1. Site contacts updated at 4 of 16 sitesv13
  2. Enrollment target: 134 to 141 Interventions: Bortezomib (Drug), Dexamethasone (Drug), Selinexor (Drug) to Bortezomib (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Selinexor (Drug) · Eligibility criteria expanded, about 135 words · Study title expanded, about 6 words · 1 morev12 Show 4 more changesShow less
    • Interventions: Bortezomib (Drug), Dexamethasone (Drug), Selinexor (Drug) to Bortezomib (Drug), Dexamethasone (Drug), Pomalidomide (Drug), Selinexor (Drug)
    • Eligibility criteria expanded, about 135 words
    • Study title expanded, about 6 words
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. 3 versions Re-verified since Apr 4, 2022, no change to tracked fieldsv9-v11
  4. Primary completion date: Jan 30, 2023 to Jun 30, 2024 Completion date: Jan 30, 2023 to Jun 30, 2025v8 Show 1 more changeShow less
    • Completion date: Jan 30, 2023 to Jun 30, 2025
  5. Site details revised at 1 of 16 sitesv7
  6. Site details revised at 1 of 16 sitesv6
  7. Site details revised at 1 of 16 sitesv5
  8. Site details revised at 11 of 16 sitesv4
  9. Study sites: 14 to 16v3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 14 · Start date changed from estimate of Jun 30, 2020 to Jul 1, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 14
    • Start date changed from estimate of Jun 30, 2020 to Jul 1, 2020
  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 study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.
Trial Details
NCT Number NCT04414475
Lead Sponsor Karyopharm Therapeutics Inc
Conditions Multiple Myeloma, Refractory
Enrollment 127 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov