Actively Recruiting
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
Led by Washington University School of Medicine · Updated on 2026-04-13
65
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Comprehensive Cancer Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates an individualized approach combining highly active maintenance treatment with elranatamab with peripheral blood-based clonotypic measurable residual disease (MRD) testing in patients with newly diagnosed multiple myeloma. The overall goal is to generate efficacy data for a personalized maintenance approach using bone marrow-based MRD testing (clonoSEQ) to guide post-autologous hematopoietic cell transplant (AHCT) maintenance with elranatamab for this patient population.
CONDITIONS
Official Title
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Ability to understand and sign informed consent
- Received autologous hematopoietic cell transplant (with or without tandem transplant) as frontline therapy for newly diagnosed IgG or IgA multiple myeloma
- Received frontline treatment with at least a triplet regimen including a proteasome inhibitor and an immunomodulatory drug (+/- anti-CD38 antibody)
- Achieved disease response of partial response or better by IMWG criteria post-transplant
- MRD-positive on Day 100 landmark (80 to 160 days after AHCT) with >1 x 10^-5 myeloma cells by clonoSEQ on bone marrow
- ECOG performance status of 2 or less
- Resolved prior treatment toxicities to Grade 1 or less
- Adequate bone marrow and organ function within 28 days prior to treatment start, including platelets ≥ 75 k/cumm, absolute neutrophil count ≥ 1.0 k/cumm, hemoglobin ≥ 8 g/dL without recent transfusion, bilirubin ≤ 2 x ULN (≤ 3 x ULN if Gilbert's syndrome), AST and ALT ≤ 2.5 x ULN, creatinine clearance ≥ 30 ml/min
- Use of adequate contraception for women of childbearing potential and men during and 5 months after treatment
You will not qualify if you...
- Inability to identify a trackable clonoSEQ ID
- History of other malignancies except non-melanoma skin cancers, low-risk prostate cancer under surveillance, or malignancies treated >2 years ago with no disease evidence
- Receiving other investigational agents
- Prior BCMA-based treatment
- CNS involvement of disease
- History of allergic reactions to elranatamab or similar compounds
- Uncontrolled illness including plasma cell leukemia, POEMS syndrome, systemic amyloidosis, or active infection
- Pregnant or breastfeeding; women must have negative pregnancy test within 28 days before treatment
- HIV infection without effective anti-retroviral therapy and undetectable viral load for 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Michael Slade, M.D.
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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