NCT06947083 Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma
| NCT ID | NCT06947083 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 39 participants in total. It began in 2025-05-27 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Ongoing active infection defined as an infection that is worsening despite therapy and causing symptoms or requiring intravenous antibiotic treatment. * Ongoing CRS or ICANS of any grade. * Active plasma cell leukemia. * Patients with CNS involvement, including meningeal involvement. * 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. * Pregnant or lactating females. * 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. * Patients with renal failure requiring dialysis.
Contact & Investigator
Melissa Alsina, MD
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT06947083 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06947083 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06947083 currently recruiting?
Yes, NCT06947083 is actively recruiting participants. Contact the research team at Tyler.Rampersaud@moffitt.org for enrollment information.
Where is the NCT06947083 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06947083 clinical trial?
NCT06947083 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Melissa Alsina, MD at Moffitt Cancer Center. The trial plans to enroll 39 participants.