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Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Official title: Study of Isatuximab Plus Pomalidomide and Dexamethasone in Highly Toxicity-vulnerable Subjects With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2023-12-05
Completion Date
2028-03-26
Last Updated
2025-10-20
Healthy Volunteers
No
Interventions
Isatuximab
Pharmaceutical form: Solution for infusion. Route of administration: Intravenous 10 mg/kg will be administered intravenously once weekly during cycle 1 and every other week during each subsequent cycle.
Pomalidomide
Pharmaceutical form: Pill for oral use. Route of administration: 3 mg Pomalidomide 3 mg pill will be taken by mouth once daily on days 1-21 of each 28-day cycle.
Dexamethasone
Pharmaceutical form: Tablet for oral use Route of administration: Pill for oral use. Dexamethasone 20 mg tablet will be taken by mouth once per week.
Locations (2)
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States