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ACTIVE NOT RECRUITING
NCT05911321
PHASE2

Isa-Pom-Dex in Elderly/Frail Subjects With RRMM

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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