RecruitingPhase 2NCT06107738

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

IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab As Post-Autologous Stem Cell Transplant Maintenance Therapy in Multiple Myeloma


Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

60 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether iberdomide (a next-generation immunomodulatory drug) combined with daratumumab (an anti-CD38 antibody) as maintenance therapy after a stem cell transplant can eliminate minimal residual disease (MRD) — microscopic traces of myeloma left behind — in multiple myeloma patients who have received daratumumab-based induction treatment. **You may be eligible if...** - You have multiple myeloma and received daratumumab-containing induction therapy with at least a partial response - You completed an autologous stem cell transplant (using your own stem cells) 90–150 days before enrolling, with no post-transplant therapy - Your disease has not progressed since the transplant - You still have detectable minimal residual disease (MRD positive) by a sensitive genetic test - Your blood counts and organ function are adequate - Your ECOG performance status is 2 or less **You may NOT be eligible if...** - Your transplant-related side effects have not resolved to mild levels (grade 1 or less) - You are pregnant or breastfeeding, or unwilling to use effective contraception - You have had a prior allogeneic (donor) stem cell transplant - Your creatinine clearance is below 30 mL/min (significant kidney impairment) - You have significant liver function abnormalities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIberdomide

Iberdomide 1.0mg daily for days 1-21 of a 28-day cycle, an increase to 1.3 mg daily on Day 1-21 of a 28-day cycle is allowed at cycle 4 or higher if the 1.0 mg dose was well tolerated.

DRUGDaratumumab/rHuPH20 Co-formulation

Daratumumab/rHuPH20 will be dosed as follows: * Daratumumab/rHuPH20 1800 mg SC days 1, 8, 15, 22 (28-day cycle; cycles 1-2) * Daratumumab/rHuPH20 1800 mg SC days 1, 15 (28-day cycle; cycles 3-6) * Daratumumab/rHuPH20 1800 mg SC day 1 (28-day cycle; cycles 7-26)


Locations(2)

Karmanos Cancer Institute

Detroit, Michigan, United States

KCI at McLaren Greater Lansing

Lansing, Michigan, United States

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NCT06107738


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