Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Summary

Primary Objectives:

* Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
* Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM

Secondary Objectives:

Safety run-in Part:

* To assess overall response rate (ORR)
* To assess duration of response (DOR)
* To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
* To assess time to diagnostic (SLiM CRAB) progression or death
* To assess time to first-line treatment for multiple myeloma (MM)
* To assess the potential immunogenicity of isatuximab
* Impact of abnormal chromosomal subtype on participant outcome

Randomized Phase 3 Part:

Key Secondary Objectives:

To compare between the arms

* MRD negativity
* Sustained MRD negativity
* Second progression-free survival (PFS2)
* Overall survival

Other Secondary Objectives:

To evaluate in both arms

* CR rate
* ORR
* DOR
* Time to diagnostic (SLiM CRAB) progression
* Time to biochemical progression
* Time to first-line treatment for MM
* Impact of abnormal chromosomal subtype on participant outcome
* Safety and tolerability
* Pharmacokinetics (PK)
* Potential of isatuximab immunogenicity
* Clinical outcome assessments (COAs)

Conditions

• Plasma Cell Myeloma

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical for: Solution for infusion Route of administration: Intravenous

DRUG

Lenalidomide

Pharmaceutical form: Capsules Route of administration: Oral

DRUG

Dexamethasone

Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous

DRUG

Montelukast or equivalent

Auxiliary Medicinal Product (AxMP)/pre-medication; ATC code: R03DC03; Pharmaceutical form: tablet; Route of administration: Oral;

DRUG

Acetaminophen

AxMP/pre-medication ATC code: N02BE01 Pharmaceutical form: tablet/ampule/capsule; Route of administration: Intravenous (IV) or per os (PO)

DRUG

Diphenhydramine or equivalent

AxMP/pre-medication ATC code: R06AA02 Pharmaceutical form: ampule; Route of administration: Intravenous

DRUG

Methylprednisolone or equivalent

AxMP/pre-medication; ATC code: H02AB04; Pharmaceutical form: vial; Route of administration: Intravenous

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

Yes

Timeline & Regulatory

Start

2020-06-16

Primary Completion

2030-10-14

Completion

2033-10-21

FDA Drug

Yes

Countries

• United States
• Australia
• Brazil
• Canada
• China
• Czechia
• Denmark
• France
• Germany
• Greece
• Hungary
• Ireland
• Israel
• Italy
• Japan
• Lithuania
• New Zealand
• Norway
• Poland
• South Korea
• Spain
• Sweden
• Turkey (Türkiye)
• United Kingdom

Study Locations