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

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.

Conditions

• Plasma Cell Myeloma Recurrent

Interventions

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

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

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

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-23

Primary Completion

2024-11-06

Completion

2027-03-23

FDA Drug

Yes

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

Study Locations