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Iberdomide Maintenance Therapy in Patients With Multiple Myeloma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Apr 15, 2022 to Jun 14, 2022 Primary completion date changed from estimate of Jan 2026 to Jan 2, 2026v10 Show 1 more changeShow less
    • Primary completion date changed from estimate of Jan 2026 to Jan 2, 2026
  2. Primary completion date: Mar 2025 to Jan 2026 Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 42 to confirmed 40 · 4 morev9 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 42 to confirmed 40
    • Eligibility criteria shortened, about 149 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 201 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Withdrawn to Recruiting Enrollment target: 0 to 42 · Study sites: 0 to 2v8 Show 2 more changesShow less
    • Enrollment target: 0 to 42
    • Study sites: 0 to 2
  4. Trial status: Recruiting to Withdrawn Sponsor's reason: PI left Enrollment target: estimated 38 to confirmed 0 · Study sites: 2 to 0v7 Show 2 more changesShow less
    • Enrollment target: estimated 38 to confirmed 0
    • Study sites: 2 to 0
  5. Study sites: 1 to 2v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study description expanded, about 75 words Site contact updatedv5 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since May 8, 2023, no change to tracked fieldsv3-v4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Feb 2025 to Mar 2025 · Completion date: Dec 2030 to Jan 2031 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 2025 to Mar 2025
    • Completion date: Dec 2030 to Jan 2031
    • Start date changed from estimate of Mar 2022 to Apr 15, 2022
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Lenalidomide maintenance therapy following autologous stem cell transplant (ASCT) is standard of care for patients with multiple myeloma. However, nearly all patients will experience disease relapse and lenalidomide's toxicity profile leads to treatment discontinuation in 30% of patients after one year. Iberdomide is a novel potent cereblon E3 ligase modulator with a favorable side effect profile. Investigators hypothesize that iberdomide maintenance therapy may result in at least 80% of subjects completing one year of maintenance. This study will determine the feasibility, safety and efficacy of iberdomide maintenance therapy post-autologous stem cell transplant (ASCT). Around day 100 after ASCT, patients will be assessed to determine study eligibility. Enrolled participants will take iberdomide pills by mouth on days 1-21 of each 28 day cycle. Physical exams, well-being status and blood and/or urine sampling will be conducted and evaluated before each cycle. Treatment will continue until disease progression or toxicity. Follow-up visits with similar testing will occur every 12 weeks until disease relapse or progression or another treatment for the disease is begun.The results from this study will inform the feasibility of pursuing a study comparing iberdomide to lenalidomide maintenance post-ASCT.
Trial Details
NCT Number NCT05177536
Lead Sponsor University of Nebraska
Conditions Multiple Myeloma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov