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NCT05405166: Phase 3: SC Versus IV Isatuximab in Combination With Pomalidomide & Dexamethasone RRMM

Updated: Sep 26

NCT05405166: Phase 3: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

subcut isatuximab

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI).


Eligible participants will be randomized 1:1 into 1 of 2 study arms:

Arm SC: Isatuximab SC + Pd

Arm IV: Isatuximab IV + Pd


Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.


Sponsor

Sanofi

 

ClinicalTrials.gov Identifier: NCT05405166

Official Title: A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

First Posted : June 6, 2022

Click here to see details on ClinicalTrials.gov

 

Dexamethasone : National Cancer Institute

Isatuximab : National Cancer Institute

Pomalidomide : National Cancer Institute

 

Drug: Isatuximab IV

Drug: Isatuximab SC

Drug: Dexamethasone

Drug: Pomalidomide

 

Locations

Australia


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