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)
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)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Bullhead City, Arizona 86442, United States
Prescott Valley, Arizona 86314, United States
Winston-Salem, North Carolina 27103, United States
Cincinnati, Ohio 45236, United States
Spartanburg, South Carolina 29303, United States
Salt Lake City, Utah 84148, United States
CABA, Buenos Aires 1280, Argentina
CABA, Buenos Aires 1430, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires 1199, Argentina
CABA, Buenos Aires F.D. 1417, Argentina
CABA, Buenos Aires F.D. C1180, Argentina
CABA, Buenos Aires F.D. C1425ASG, Argentina
Fortaleza, Ceará 60115-281, Brazil
Ostrava - Poruba, 70852, Czechia
Kamogawa-shi, Chiba 296-8602, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Shiwa-gun, Iwate 028-3695, Japan
Kamakura-shi, Kanagawa 247-0072, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Shibuya-ku, Tokyo 150-8935, Japan