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Recruiting

NCT Number: NCT06947083

Elranatamab Post 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Ariel Grajales-Cruz, MD

SUB_INVESTIGATOR

Brandon Blue, MD

SUB_INVESTIGATOR

Ciara Freeman, MD, MSc, PhD

SUB_INVESTIGATOR

Doris Hansen, MD

SUB_INVESTIGATOR

Frederick Locke, MD

SUB_INVESTIGATOR

Hien Liu, MD

SUB_INVESTIGATOR

Kenneth Shain, MD, PhD

SUB_INVESTIGATOR

Melissa Alsina, MD

PRINCIPAL_INVESTIGATOR

Omar Castaneda Puglianini, MD

SUB_INVESTIGATOR

Rachid Baz, MD

SUB_INVESTIGATOR

Taiga Nishihori, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elranatamab

Drug

Maintenance therapy

Primary outcomes

  1. Progression Free Surival (PFS)

    Time frame: Up to 24 Months

    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.

Secondary outcomes

  1. Complete Response

    Time frame: Up to 12 months

    Proportion of participants with a complete response at the end of treatment.

  2. MRD Negative

    Time frame: Up to 12 months

    Proportion of participants with MRD negativity at the end of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Tyler rampersaud

CONTACT

[email protected]

813-745-8272

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 27, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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