Tests elranatamab after cilta-cel in high-risk relapsed myeloma
Tests elranatamab after cilta-cel in adults with relapsed high-risk myeloma.
Key facts
- Who runs it
- H. Lee Moffitt Cancer Center and Research Institute
- Where
- Tampa, United StatesSee the site
- Trial code
- Registry title
- Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 39 people, planned
- Started
- 27 May 2025
- Expected to end
- Apr 2029
- Type of study
- Interventional
- Treatments tested
- Elranatamab
- Record updated
- 3 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsed myeloma who had cilta-cel 3-6 months ago, have high-risk myeloma features, and show no sign of progression.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed refractory myeloma with high-risk cytogenetics (del17p, t(4;14) or t(14;16)) or a history of EMD, and no progressive disease after CAR-T therapy.
- Earlier treatment
- Commercial cilta-cel within 3-6 months. More than 2 earlier treatment regimens, including an immunomodulatory drug, a proteasome inhibitor and a CD38 monoclonal antibody.
- Biomarker or test result
- High-risk cytogenetics (del17p, t(4;14) or t(14;16)) or a history of EMD. A clonoseq ID must be available before enrollment to track MRD status.
Main reasons for not taking part
- Active infection that is worsening despite treatment
- Ongoing CRS or ICANS of any grade
- Active plasma cell leukemia or CNS involvement
- History of Guillain-Barre syndrome
- Known HIV, hepatitis B or hepatitis C infection, or renal failure requiring dialysis
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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, and must not have evidence of progressive disease by IMWG criteria(Appendix B) following CAR-T cell therapy
- Have received >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
- Patients 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 ≤1.5 times the upper limit of the normal range for the laboratory (ULN), unless related to Gilbert syndrome
- Serum AST or serum ALT levels ≤2 x ULN
- Must have adequate bone marrow function
Who cannot take part
- Concurrent use of other anti-cancer agents or treatments
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Note: patients with hepatitis C previously treated with curative intent are considered eligible
- Ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment
- Patients with 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 felt to be secondary to multiple myeloma, which in the opinion of the treating physician pose an unacceptable risk to the patient
- Patients with renal failure requiring dialysis
- Ongoing CRS or ICANS of any grade
- Active plasma cell leukemia
- Patients with CNS involvement, including meningeal involvement
- Pregnant or lactating females
Where in United States
- Moffitt Cancer CenterTampa, United StatesContact: Melissa Alsina, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Elranatamab Maintenance TherapyTreatment being tested
Patients who have received cilta-cel without evidence of disease progression and have clinical high-risk myeloma, will be treated with Elranatamab as maintenance therapy for a total of 12 months starting 3-6 months post cilta-cel infusion, at the FDA approved full dose.
Treatment: Elranatamab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Phase II Study of Elranatamab as Maintenance Therapy Post Ciltacabtagene-autoleucel(Cilta-cel) in Patients With Clinical High Risk Relapsed Myeloma
- Plain-language title
- Tests elranatamab after cilta-cel in high-risk relapsed myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 December 2025