IRAKLIA
Research type
Research Study
Full 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)
IRAS ID
1005756
Contact name
Eniana Shkurti
Contact email
Sponsor organisation
Sanofi-aventis recherche & developpement
Eudract number
2021-002485-41
Clinicaltrials.gov Identifier
Research summary
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 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; Subcutaneous arm , which consists of isatuximab injection using the investigational injector device, in combination with lenalidomide and dexamethasone tablets, and the IV arm, which consists of intravenous administration of isatuximab, in combination with lenalidomide and dexamethasone tablets. 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. Once the baseline/screening visit has taken place, the eligible patient enter treatment cycles of 28 day cycles, up until the end of treatment or follow up visit. There is an option for the participant to have at home administration of their treatment after cycle 5 (this decision requires investigator review and approval). The home healthcare will be provided with by a vendor and a health care professional will go to the patients home to administer treatment, the responsibility of all study procedures lies with the PI.
REC name
HSC REC A
REC reference
22/NI/0171
Date of REC Opinion
14 Apr 2023
REC opinion
Further Information Favourable Opinion