Actively Recruiting
Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma
Led by YOUNGIL KOH · Updated on 2025-12-03
75
Participants Needed
7
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.
CONDITIONS
Official 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 time of informed consent
- Ability to understand and voluntarily sign informed consent form
- Willingness and ability to follow study visit schedule and protocol
- Documented diagnosis of multiple myeloma with measurable disease defined by M-protein levels or serum free light chain levels
- Patients with measurable disease and extramedullary lesions allowed; patients with extramedullary disease only not eligible
- 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 last antimyeloma regimen
- ECOG performance status of 0, 1, or 2
- Individuals of childbearing potential must have negative pregnancy tests and agree to contraceptive measures or abstinence
- Male subjects must agree to use condoms or abstinence and refrain from sperm donation during and after treatment
- Agreement to refrain from donating blood and receiving live vaccines during and after treatment
You will not qualify if you...
- Prior treatment with mezigdomide
- Gastrointestinal disease or surgery affecting absorption of mezigdomide or other oral study drugs
- Prior treatment with anti-BCMA agents including CAR T-cell therapy and bispecific antibodies
- Use of investigational agents within 28 days or five half-lives before study treatment
- Participation in another interventional clinical trial concurrently, except long-term follow-up
- Recent plasmapheresis, major surgery, radiation therapy (other than local palliative), systemic antimyeloma therapy, or potassium competitive acid blockers within specified timeframes before study treatment
- Recent allogeneic stem cell transplantation within one year or autologous stem cell transplantation within 12 weeks
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or clinically significant light-chain amyloidosis
- Known central nervous system involvement with myeloma
- Significant medical conditions including uncontrolled infection or psychiatric illness posing unacceptable treatment risk
- Recent COVID-19 infection within 7 to 14 days before treatment
- Conditions confounding study data interpretation
- Laboratory abnormalities including low neutrophil or platelet counts, low hemoglobin, low 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 unless disease-free for 3 years
- Recent immunosuppressive medication use except specified exceptions
- Use of strong CYP3A modulators or proton-pump inhibitors within 2 weeks before treatment
- Impaired cardiovascular function or significant cardiac diseases within 6 months
- Uncontrolled hypertension or diabetes within 14 days
- Receipt of live vaccine within 3 months
- Inability or unwillingness to comply with thromboembolism or antiviral prophylaxis
- Positive for HIV, chronic or active hepatitis B, active hepatitis A or C
- History of severe allergic reactions or contraindications to study drugs
- Pregnant, nursing, breastfeeding, or intending to become pregnant during study participation
AI-Screening
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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
CONTACT
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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