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Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib

Study acronym: IPoD-790
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Mar 1, 2026 → Sep 1, 2027
See other at-risk trials from Tel-Aviv Sourasky Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 1, 2026 to Sep 1, 2027
    • Study completion moved earlier from Sep 1, 2029 to Jan 1, 2028
    v16
  2. Minor Study Identification, Study Status, Oversightv15
  3. Minor Enrollment target: estimated 60 to confirmed 61v14
  4. Notable Primary completion date: Sep 1, 2024 to Mar 1, 2026
    • Study completion date: Oct 1, 2024 to Sep 1, 2029
    v13
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 8 to 7
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Site contacts updated at 1 of 8 sitesv11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Minor Study sites: 7 to 8v9
  4. Minor Study sites: 6 to 7v8
  5. Minor Site details revised at 1 of 6 sitesv7
  6. Minor Site details revised at 2 of 6 sitesv6
  7. Minor Study sites revised (6)v5
  8. Minor Start date changed from estimate of Mar 17, 2021 to Mar 25, 2021v4
  9. Minor Re-verified, no change to tracked fieldsv3
  10. Notable Primary endpoint revisedv2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 240 words
    • Site details revised at 1 of 6 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study. During the first three treatment cycles, patients will be seen twice (Days 1 and 15 of the cycle). Starting from cycle 4 and on, patients will be assessed once per cycle (Day 1), until disease progression, for disease response and progression according to the International Myeloma Working Group (IMWG) criteria. After progression, all patients will be followed for survival; for this purpose, patients will be contacted every 12 weeks until death or termination of the study by the Sponsor. Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.
Trial Details
NCT Number NCT04790474
Lead Sponsor Tel-Aviv Sourasky Medical Center
Conditions
(from sponsor)
Multiple Myeloma in Relapse, Refractory Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov