Health TrialsbyHealthPanel

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

ConditionMyeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Elranatamab

    Drug

    Maintenance therapy

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Elranatamab Maintenance TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 Months

Secondary outcomes

1

Complete Response

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

Time frame
Up to 12 months
2

MRD Negative

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

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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