NCT05405166

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in 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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 531 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plasma Cell Myeloma Recurrent

Interventions

Type	Name	Description
DRUG	Isatuximab IV	Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
DRUG	Isatuximab SC	Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
DRUG	Dexamethasone	Pharmaceutical form: Tablet; Route of administration: Oral
DRUG	Pomalidomide	Pharmaceutical form: hard capsules; Route of administration: Oral
DRUG	Dexamethasone	Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02
DRUG	Montelukast	Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03
DRUG	Paracetamol / Acetaminophen	Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01
DRUG	Diphenhydramine	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
DRUG	Methylprednisolone	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

Timeline

• Start date: 2022-06-23
• Primary completion: 2024-11-06
• Completion: 2027-03-23
• First posted: 2022-06-06
• Last updated: 2025-11-14
• Results posted: 2025-11-14

Locations

146 sites across 21 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Italy, Japan, Norway, Poland, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study