Actively Recruiting
Phase II Study of Elranatamab as Maintenance Therapy Post Ciltacabtagene-autoleucel (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
N/A
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
This research aims to evaluate the effect of Elranatamab therapy as a maintenance treatment after receiving ciltacabtagene-autoleucel (cilta-cel) in patients with clinical high-risk relapsed myeloma. High-risk myeloma includes patients with a history of myeloma that has spread outside the bones or those with high-risk mutations in myeloma cells. These patients typically benefit less from cilta-cel, so the study focuses on improving how long they live without their disease worsening, known as progression-free survival (PFS). Participants who have received cilta-cel without signs of disease progression and have clinical high-risk myeloma will receive Elranatamab maintenance therapy. This treatment will start 3 to 6 months after the cilta-cel infusion and continue for 12 months at the FDA-approved full dose. During this time, patients will be closely monitored to assess the treatment's effects. Throughout the study, participants will have regular visits to track their response to Elranatamab and monitor side effects. Researchers will measure progression-free survival for up to 24 months and evaluate other outcomes such as complete response and minimal residual disease (MRD) negativity over 12 months. Participants must be able to follow the visit schedule and protocol requirements for successful monitoring and data collection.
CONDITIONS
Brief 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 and have high risk cytogenetics by IMW (del17p, or t(4;14) or t(14;16) or history of EMD).
- Must not have evidence of progressive disease following CAR-T cell therapy.
- 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 less than or equal to 1.5 times the upper limit of normal (ULN), unless related to Gilbert syndrome.
- Serum AST or ALT levels less than or equal to 2 times ULN.
- Must have adequate bone marrow function.
You will not qualify if you...
- Ongoing active infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment.
- Ongoing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade.
- Active plasma cell leukemia.
- CNS involvement, including meningeal involvement.
- History of Guillain-Barre syndrome.
- Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic and renal diseases unless renal insufficiency is due to multiple myeloma.
- Pregnant or lactating females.
- Concurrent use of other anti-cancer agents or treatments.
- Known seropositive for or active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) unless previously treated with curative intent.
- Renal failure requiring dialysis.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive Elranatamab as maintenance therapy for 12 months starting 3-6 months after their previous cilta-cel infusion.
Visits scheduled throughout the 12-month treatment period
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
T
Tyler rampersaud
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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