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Safety and Efficacy Study of OPC-415 in Patients With Relapsed and/or Refractory Multiple Myeloma

StatusTerminated
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: This is because the decision was made to conclude the trial at Phase I and not proceed to Phase II. Study completion date changed from estimate of Jan 2041 to Apr 9, 2025v11 Show 1 more changeShow less
    • Study completion date changed from estimate of Jan 2041 to Apr 9, 2025
  2. Re-verified, no change to tracked fieldsv10
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 49 to confirmed 11 · Study sites: 5 to 8 · Primary completion date changed from estimate of Jan 2027 to Apr 9, 2025v9 Show 3 more changesShow less
    • Enrollment target: estimated 49 to confirmed 11
    • Study sites: 5 to 8
    • Primary completion date changed from estimate of Jan 2027 to Apr 9, 2025
  4. 4 versions Re-verified since Apr 18, 2022, no change to tracked fieldsv5-v8
  5. Site details revised at 1 of 5 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 5 Start date changed from estimate of Dec 2020 to Feb 18, 2021v3 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2020 to Feb 18, 2021
  2. Trial status: Not Yet Recruiting to Recruiting Study site revisedv2 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the tolerability,safety and efficacy of OPC-415 in patients with relapsed and/or refractory Multiple Myeloma (MM).
Trial Details
NCT Number NCT04649073
Lead Sponsor Otsuka Pharmaceutical Co., Ltd.
Conditions Multiple Myeloma (MM)
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov