Actively Recruiting
Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-03
39
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the effect of Elranatamab therapy after cilta-cel measuring how long a patient with high risk relapsed myeloma lives without the myeloma getting worse(progressing), also known as progression-free survival (PFS). Patients with clinical high-risk myeloma, defined as having history of myeloma that has grown outside of the bones or having high risk mutations in the myeloma cells, benefit less from cilta-cel compared to myeloma patients without these characteristics.
CONDITIONS
Official Title
Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign an informed consent form.
- Have received commercial cilta-cel within 3-6 months for relapsed refractory myeloma.
- Have high risk cytogenetics by IMW (del17p, t(4;14), t(14;16)) or history of extramedullary disease (EMD).
- Must not have evidence of progressive disease following CAR-T cell therapy by IMWG criteria.
- Have received more than 2 prior treatment regimens including an immunomodulatory drug, a proteasome inhibitor, and a CD38 monoclonal antibody.
- Able to adhere to the study visit schedule and other protocol requirements.
- Must have available clonoseq ID prior to enrollment to track MRD status.
- Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
- Serum bilirubin levels no more than 1.5 times the upper limit of normal unless related to Gilbert syndrome.
- Serum AST or ALT levels no more than 2 times the upper limit of normal.
- Must have adequate bone marrow function.
You will not qualify if you...
- Ongoing active infection that is worsening despite therapy or requires intravenous antibiotics.
- Ongoing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade.
- Active plasma cell leukemia.
- Central nervous system (CNS) involvement, including meningeal involvement.
- History of Guillain-Barre syndrome.
- Uncontrolled medical problems such as diabetes, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic, or renal diseases unless related to myeloma.
- Pregnant or lactating females.
- Concurrent use of other anti-cancer agents or treatments.
- Known active or seropositive infection with HIV, hepatitis B, or hepatitis C (except vaccinated or cured cases).
- Renal failure requiring dialysis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
T
Tyler rampersaud
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here