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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06947083
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression Free Surival (PFS) [ Time Frame: Up to 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Melissa Alsina, MD (PRINCIPAL_INVESTIGATOR)
Rachid Baz, MD (SUB_INVESTIGATOR)
Brandon Blue, MD (SUB_INVESTIGATOR)
Omar Castaneda Puglianini, MD (SUB_INVESTIGATOR)
Ciara Freeman, MD, MSc, PhD (SUB_INVESTIGATOR)
Doris Hansen, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Kenneth Shain, MD, PhD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Ariel Grajales-Cruz, MD (SUB_INVESTIGATOR)
Hien Liu, MD (SUB_INVESTIGATOR)

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