Iberdomide + Daratumumab for Multiple Myeloma
(IBEX Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use strong inhibitors or inducers of certain enzymes (CYP3A4, P-gp, or BCRP) for at least 14 days before starting the trial treatment.
What data supports the effectiveness of the drug Daratumumab for treating multiple myeloma?
Daratumumab has shown to be effective in treating multiple myeloma, with studies indicating that it can improve progression-free survival and overall response rates when used alone or in combination with other drugs like bortezomib and dexamethasone. In various trials, it has demonstrated significant clinical activity, especially in patients with relapsed or refractory multiple myeloma, and is generally well tolerated.12345
Is the combination of Iberdomide and Daratumumab safe for humans?
Daratumumab, also known as Darzalex, has been shown to have an acceptable safety profile in treating multiple myeloma, both as a single agent and in combination with other drugs. It has been well-tolerated in patients, including those with relapsed or refractory multiple myeloma, and has been used in various treatment regimens with a favorable toxicity profile.24567
How does the drug Iberdomide + Daratumumab differ from other treatments for multiple myeloma?
Iberdomide + Daratumumab is unique because it combines a new drug, Iberdomide, with Daratumumab, a monoclonal antibody that targets a specific protein on multiple myeloma cells. This combination aims to enhance the immune system's ability to fight cancer cells, potentially offering a novel approach compared to existing treatments that often involve different drug combinations or single-agent therapies.23678
Research Team
Jeffrey Zonder, M.D.
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Eligibility Criteria
This trial is for Multiple Myeloma patients who've had prior therapy with Daratumumab, responded at least partially, completed an Autologous Stem Cell Transplant (ASCT) within the last 90-150 days without progression, and are Minimal Residual Disease positive. They must be physically able to perform daily activities with minimal assistance (ECOG Performance Status ≤2), have adequate bone marrow function and organ function.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Iberdomide and SC Daratumumab as maintenance therapy post-ASCT, with dose adjustments based on tolerance, for up to 26 cycles or until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRD assessments at 6, 12, and 24 months
Treatment Details
Interventions
- Daratumumab
- Iberdomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Multiple Myeloma Research Consortium
Collaborator
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE Business School
John (Jack) Lawrence
Janssen Pharmaceuticals
Chief Medical Officer since 2023
MD from University of Virginia School of Medicine