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
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
Treatments tested in this trial
- Elranatamab
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov