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Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Collaborators: 1 to 2v8
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 15 to 62
    • Site details revised
    v7
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 15
    • Site details revised
    v6
  4. Minor Re-verified, no change to tracked fieldsv5
  5. Minor Study site revisedv4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 20, 2021 to Jun 2, 2021
    • Site details revised
    v3
  2. Notable Start date: Oct 1, 2020 to Mar 20, 2021
    • Secondary endpoints revised (5)
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.
Trial Details
NCT Number NCT04558931
Lead Sponsor Karolinska Institutet
Collaborators: Sanofi, XNK Therapeutics AB, Sweden
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov