Isatuximab SAR650984 for Neoplasms, Plasma Cell

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Neoplasms, Plasma Cell+6 More
Isatuximab SAR650984 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a drug to see if it can help people with a certain type of cancer.

Eligible Conditions
  • Neoplasms, Plasma Cell
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 17 Secondary · Reporting Duration: End of treatment (up to approximately 10 years)

Month 100
Safety assessment: adverse events (AEs)
Day 28
Receptor density/receptor occupancy (safety run-in)
Year 10
EORTC QLQ-MY20
EQ-5D-5L
Economic questionnaire
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Year 10
Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2)
Month 120
Second PFS (PFS2)
Month 144
Overall survival
Month 24
Immunogenicity: Incidence of anti-drug antibodies (ADA)
Plasma concentration of isatuximab
Plasma concentration of isatuximab: Cmax
Month 85
Complete response rate
Duration of response (DOR)
Minimal residual disease (MRD) negativity
Overall response rate (ORR)
Progression-free survival (PFS) randomized Phase 3
Sustained MRD negativity
Time to diagnostic (SLiM CRAB) progression or death
Time to first-line treatment for multiple myeloma (MM)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Lenalidomide and dexamethasone (Ld)
1 of 2
Isatuximab, lenalidomide, and dexamethasone (ILd)
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Isatuximab SAR650984 · No Placebo Group · Phase 3

Isatuximab, lenalidomide, and dexamethasone (ILd)Experimental Group · 3 Interventions: Dexamethasone, Lenalidomide, Isatuximab SAR650984 · Intervention Types: Drug, Drug, Drug
Lenalidomide and dexamethasone (Ld)ActiveComparator Group · 2 Interventions: Dexamethasone, Lenalidomide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Isatuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: end of treatment (up to approximately 10 years)

Who is running the clinical trial?

SanofiLead Sponsor
2,032 Previous Clinical Trials
2,956,204 Total Patients Enrolled
34 Trials studying Neoplasms, Plasma Cell
7,089 Patients Enrolled for Neoplasms, Plasma Cell
Clinical Sciences & OperationsStudy DirectorSanofi
790 Previous Clinical Trials
1,631,645 Total Patients Enrolled
19 Trials studying Neoplasms, Plasma Cell
3,505 Patients Enrolled for Neoplasms, Plasma Cell

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.