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.
Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: hard capsules; Route of administration: Oral
Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01
Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02
Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04
CABA, Buenos Aires, Argentina
CABA, Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
CABA, Buenos Aires F.D., Argentina
CABA, Buenos Aires F.D., Argentina
CABA, Buenos Aires F.D., Argentina
Córdoba, Córdoba Province, Argentina
Buenos Aires, Argentina
Mendoza, Argentina