IRAKLIA
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)
Sponsor: Sanofi
Conditions: Plasma Cell Myeloma Recurrent
Brief 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 (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.
Detailed Description: Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Intervention/Treatment:
- Drug: Isatuximab IV
- Drug: Isatuximab SC
- Drug: Dexamethasone
- Drug: Pomalidomide
- Drug: Dexamethasone
- Drug: Montelukast
- Drug: Paracetamol / Acetaminophen
- Drug: Diphenhydramine
- Drug: Methylprednisolone
Learn More: Additional details about this study are available on https://clinicaltrials.gov/study/NCT05405166
Questions or Interested in Participating? To learn more about participation at our site, please contact our study team:
(801) 584-5665 or submit an inquiry.