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Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma

Study acronym: IBEX
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2028
    • Site contacts updated at 2 of 2 sites
    v5
  2. Minor Study sites: 1 to 2v4
  3. Minor Start date changed from estimate of Jan 16, 2024 to Dec 21, 2023
    • Site contact updated
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Jan 1, 2024 to Jan 16, 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this phase 2 clinical trial is to learn if patients with Multiple Myeloma who are minimal residual disease positive after initial therapy (including an autologous stem cell transplant \[ASCT\]) will benefit from maintenance therapy with Iberdomide and subcutaneous (SC) Daratumumab. The main questions it aims to answer are: * Assess if giving Iberdomide and the SC Daratumumab in the maintenance setting is an effective treatment and warrants further investigation in patients with residual disease * Is giving Iberdomide and SC Daratumumab maintenance post ASCT a safe option Participants will: * provide informed consent and complete screening assessments for eligibility within 28 days of starting treatment * Screening assessments include specific laboratory tests, a medical history assessment and a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), an assessment of your heart function, a breathing test, cancer imaging, a bone marrow biopsy, minimal residual disease testing (MRD) and a questionnaire * If eligible, patients will start treatment with Iberdomide (1.0 mg on day 1-21 of each 28 day cycle, with an increase to 1.3 mg on Cycle 4 if the 1.0 mg dose was tolerated, to a maximum of 26 cycles or progressive disease, whichever is first) and SC Daratumumab (1800 mg SC on days 1, 8, 15 and 22 of cycle 1 and 2, then 1800 mg SC on Day 1 and 15 of cycle 3-6 and 1800 mg SC on Day 1 for cycles 7-26 to a maximum of 26 cycles or progressive disease, whichever is first) * while receiving treatment on study, physical exams (including temperature, pulse, blood pressure, respirations, height and weight), toxicity assessments, laboratory assessments and questionnaires will be done at various times over the course of the 26 cycles * an MRD assessment is required at 6, 12 and 24 months after starting treatment * End of treatment will occur once 26 cycles are completed, or cancer has progressed whichever comes first. At that time, specific laboratory tests, a physical examination (including temperature, pulse, blood pressure, respirations, height and weight), cancer imaging, a bone marrow biopsy and minimal residual disease testing (MRD) will occur.
Trial Details
NCT Number NCT06107738
Lead Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators: Bristol-Myers Squibb, Janssen Pharmaceuticals, Multiple Myeloma Research Consortium
Conditions
(from sponsor)
Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov