drugset / Trial / NCT05145400

Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma

NCT05145400

NaSingle-groupOpen-labelTreatment

Summary

This research study is investigating the safety and effectiveness of using combination of isatuximab, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM). The study team will use lower doses than is currently standard for these drugs. Lower doses will be used to avoid or possibly reduce any unwanted side effects commonly associated with these drugs. Using lower doses of the combination isatuximab, lenalidomide and dexamethasone, has not been approved by the Food and Drug Administration (FDA) for the treatment of newly diagnosed MM.

Timeline

Start
2022-02-18
Primary completion
2033-05-28
Completion
2033-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Oral
Subject Isatuximab Monoclonal antibody 10 mg/kg Intravenous
Subject Isatuximab Monoclonal antibody 1400 mg Intravenous
Subject Lenalidomide Other / unclassified 2.5 mg Oral
Subject Lenalidomide Other / unclassified 5 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral

Indications