Actively Recruiting
Phase I/II Study of Mezigdomide and Elranatamab for Relapsed/Refractory Multiple Myeloma Patients
Led by YOUNGIL KOH · Updated on 2025-12-03
75
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how well a combination of two medicines, mezigdomide and elranatamab, works in treating patients with relapsed or refractory multiple myeloma. This phase I/II, open-label, single-arm, multicenter trial aims to evaluate the safety, tolerability, and effectiveness of this combination treatment. The study is led by Youngil Koh and focuses on patients who have received prior therapies but whose disease has progressed. The study has two parts. Part 1 will include about 12 participants to find the recommended phase 2 dose and assess safety and preliminary effectiveness. Part 2 will enroll approximately 63 participants to determine the overall response rate at 24 months. Participants will receive elranatamab by subcutaneous injection with a step-up dosing schedule, oral mezigdomide capsules daily for 21 days per 28-day cycle, and dexamethasone as premedication. Dosing schedules adjust based on response levels and disease progression. Participants will undergo regular assessments including response evaluations using International Myeloma Working Group criteria over 24 months. Researchers will monitor disease progression, survival, safety, and minimal residual disease status. The study includes frequent visits during treatment cycles with monitoring of laboratory tests, imaging, and clinical status. The study duration covers treatment and follow-up to capture long-term outcomes and side effects.
CONDITIONS
Brief Title
Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at the time of informed consent.
- Able to understand and voluntarily sign the informed consent form.
- Willing and able to follow the study visit schedule and requirements.
- Documented diagnosis of multiple myeloma with measurable disease by specified criteria.
- Received two or more prior lines of antimyeloma therapy.
- Received at least one proteasome inhibitor and lenalidomide.
- Achieved minimal response or better to at least one prior antimyeloma therapy.
- Documented disease progression during or after the last antimyeloma treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- For individuals of childbearing potential, agreement to pregnancy testing and use of effective contraception or true abstinence.
- Agreement to avoid donating sperm, eggs, or blood during and after study treatment as specified.
- Agreement to avoid live vaccines during and after study treatment as specified.
You will not qualify if you...
- Prior treatment with mezigdomide or anti-BCMA agents including CAR T-cell therapy.
- Recent use of investigational agents within 28 days or 5 half-lives before study treatment.
- Recent plasmapheresis, major surgery, radiation therapy (other than palliative), or systemic antimyeloma therapy within specified timeframes before treatment.
- Gastrointestinal disease or surgery affecting absorption of oral treatment.
- Stem cell transplantation within defined timeframes prior to treatment.
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or significant light-chain amyloidosis.
- Central nervous system involvement with myeloma.
- Significant medical conditions or uncontrolled infections increasing risk for treatment complications.
- Recent COVID-19 infection within specified timeframes.
- Laboratory abnormalities including low neutrophil or platelet counts, low hemoglobin, poor kidney function, high calcium, elevated liver enzymes, or bilirubin.
- Peripheral neuropathy grade 2 or higher, history of Guillain-Barre syndrome or severe motor neuropathy.
- History of malignancies other than multiple myeloma within 3 years except certain skin cancers or carcinoma in situ.
- Recent use of immunosuppressive medication except specified exceptions.
- Use of strong CYP3A modulators or proton-pump inhibitors within 2 weeks before treatment.
- Impaired or significant cardiovascular diseases within 6 months before enrollment.
- Uncontrolled hypertension or diabetes within 14 days before enrollment.
- Recent live vaccine within 3 months before study therapy.
- Unable or unwilling to follow required prophylaxis protocols.
- Positive for HIV, active hepatitis B, hepatitis A, or hepatitis C.
- History of severe hypersensitivity to study drugs or excipients.
- Pregnant, nursing, or planning pregnancy during study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or discontinuation
Participants receive a combination of elranatamab, mezigdomide, and dexamethasone. Elranatamab is administered subcutaneously with an initial step-up dosing regimen followed by weekly, bi-weekly, and then monthly dosing depending on response. Mezigdomide is taken orally daily for 21 days in 28-day cycles. Dexamethasone is given as a premedication with varying doses during the early cycles.
Weekly or bi-weekly visits during initial cycles, then less frequent visits as dosing intervals extend
Trial Site Locations
Total: 7 locations
1
National University Hospital (NUH)
Singapore, Singapore
Actively Recruiting
2
Singhealth Duke NUS blood cancer center
Singapore, Singapore
Actively Recruiting
3
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Actively Recruiting
4
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Actively Recruiting
5
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea
Not Yet Recruiting
7
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, South Korea
Actively Recruiting
Research Team
Y
Youngil Koh, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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