Actively Recruiting
Elranatamab in Relapsed/Refractory Multiple Myeloma
Led by University of California, San Diego · Updated on 2026-02-20
33
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the efficacy of elranatamab alone in patients with relapsed and/or refractory Multiple myeloma who has previously received 1 to 3 combinations of treatment.
CONDITIONS
Official Title
Elranatamab in Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with study procedures and available for study duration
- Diagnosed with relapsed/refractory multiple myeloma and received 1 to 3 prior treatments including anti-CD38 antibody, proteasome inhibitor, immunomodulatory drug, and BCMA-directed CAR T-cell therapy (or ineligible/deferred for CAR T-cell therapy)
- Age 18 years or older
- Measurable disease defined by serum M-protein 650.5 g/dL, urine M-protein 65200 mg/24 hours, or involved serum free light chain 6510 mg/dL with abnormal ratio
- ECOG performance status of 0, 1, or 2
- Adequate blood counts: ANC 651,000/mm3, hemoglobin 658.0 g/dL, platelet count 6575,000/mm3 (or 6550,000/mm3 if >50% plasma cell involvement)
- Adequate kidney function with creatinine clearance 6530 mL/min
- Adequate liver function: AST/ALT 652.5 x ULN (up to 5 x ULN if liver involved), alkaline phosphatase 652.5 x ULN (up to 5 x ULN if bone metastasis), total bilirubin 652.0 mg/dL (up to 3.0 mg/dL with Gilbert Syndrome)
- Able to receive outpatient treatment: live within 30 minutes of site, have reliable caregiver for 48 hours after first dose, no history of severe CRS or ICANS
- Acute effects of prior therapy resolved to baseline or grade 1
- Negative serum pregnancy test for females of childbearing potential
- Female patients of non-childbearing potential must meet criteria for postmenopausal status or surgical sterilization
- Agreement to follow lifestyle considerations throughout study
You will not qualify if you...
- Smoldering multiple myeloma, IgM multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome, or plasma cell leukemia with 655% circulating plasma cells
- Extramedullary relapse without measurable disease
- Active malignancy other than multiple myeloma needing treatment in past 3 years except treated non-metastatic skin cancer
- Known CNS involvement by multiple myeloma
- Active uncontrolled autoimmune disorders
- Active uncontrolled infection unresolved for at least 14 days
- Radiation therapy within 2 weeks prior to study entry (except limited bone radiation)
- Last systemic treatment within 2 weeks or 5 half-lives (whichever shorter)
- Last radiation treatment to multiple sites within 2 weeks or single site within 1 week
- Autologous stem cell transplant within 100 days
- Allogeneic transplant within 1 year or active graft versus host disease
- On immunosuppressive therapy for other conditions
- Major uncontrolled medical comorbidities or significant cardiac disease
- Grade 2 peripheral neuropathy
- History of Guillain-Barre syndrome
- Recent or active suicidal ideation or major psychiatric conditions
- Investigational drug use within 30 days or 5 half-lives
- Pregnancy or breastfeeding
- Known or suspected allergy to elranatamab or its ingredients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
A
Ah-Reum Jeong
CONTACT
B
Bone Marrow Transplant Research Team
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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