OncoMatch/Clinical Trials/NCT06107738
Iberdomide and Daratumumab As Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma
Is NCT06107738 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Iberdomide and Daratumumab/rHuPH20 Co-formulation for multiple myeloma.
Treatment: Iberdomide · Daratumumab/rHuPH20 Co-formulation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD38 antibody (daratumumab) — induction
prior DARA-containing induction therapy (at least 3 cycles), attaining at least a partial response
Must have received: autologous stem cell transplant
completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without post-ASCT disease progression
Cannot have received: post-ASCT therapy
without any post-ASCT therapy
Cannot have received: anti-CD38 antibody (daratumumab)
Exception: intolerance requiring discontinuation due to toxicity
Intolerance of prior DARA therapy (requiring discontinuation of DARA previously due to toxicity)
Lab requirements
Blood counts
platelets >= 75,000/mm3, hemoglobin >= 8 g/dL (transfusion allowed), ANC >= 1,000/mm3
Kidney function
creatinine clearance (CrCl) >= 30 mL/min (24-hour urine or Cockcroft-Gault)
Liver function
total bilirubin <=1.5 x IULN (except Gilbert's syndrome); AST and ALT <=3.0 x IULN
Adequate bone marrow function as evidenced by platelets >= 75,000/mm3, hemoglobin >= 8 g/dL, and ANC >= 1,000/mm3 within 28 days prior to registration. Adequate hepatic function defined by: total bilirubin <=1.5 x IULN (except Gilbert's syndrome) AND AST and ALT <=3.0 x IULN. Adequate renal function: CrCl >= 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Karmanos Cancer Institute · Detroit, Michigan
- KCI at McLaren Greater Lansing · Lansing, Michigan
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