Elranatamab Post Cilta-cel in Patients With Clinical High Risk Relapsed Myeloma

Phase II Study of Elranatamab as Maintenance Therapy Post Ciltacabtagene-autoleucel(Cilta-cel) in Patients With Clinical High Risk Relapsed Myeloma

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.

Study Overview

• Status: Recruiting
• Conditions: Myeloma
• Intervention / Treatment: Drug: Elranatamab

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tyler rampersaud; Phone Number: 813-745-8272; Email: Tyler.Rampersaud@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Doris Hansen, MD
      • Sub-Investigator: Hien Liu, MD
      • Sub-Investigator: Omar Castaneda Puglianini, MD
      • Sub-Investigator: Rachid Baz, MD
      • Sub-Investigator: Brandon Blue, MD
      • Sub-Investigator: Frederick Locke, MD
      • Sub-Investigator: Taiga Nishihori, MD
      • Principal Investigator: Melissa Alsina, MD
      • Sub-Investigator: Ciara Freeman, MD, MSc, PhD
      • Sub-Investigator: Kenneth Shain, MD, PhD
      • Sub-Investigator: Ariel Grajales-Cruz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elranatamab Maintenance Therapy; 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.	Drug: Elranatamab; Maintenance therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Surival (PFS)	Progression-free survival (PFS) is measured from the date of initiation of Elranatamab (i.e., on-treatment date) to either the date of death from any cause or the date of disease progression, whichever comes first.	Up to 24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response	Proportion of participants with a complete response at the end of treatment.	Up to 12 months
MRD Negative	Proportion of participants with MRD negativity at the end of treatment.	Up to 12 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Melissa Alsina, MD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Plasma Cell
• Other Study ID Numbers: MCC-23564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No