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Checkpoint Inhibitor

Isatuximab SAR650984 for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months from lpi for primary efficacy analysis, and up to 12 months from lpi for the final analysis
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a combination of two drugs, isatuximab and cemiplimab, for patients with multiple myeloma who have relapsed or are refractory to other treatments.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months from lpi for primary efficacy analysis, and up to 12 months from lpi for the final analysis
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months from lpi for primary efficacy analysis, and up to 12 months from lpi for the final analysis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (AEs) and changes in laboratory tests and vital signs
Dose Limiting Toxicities (DLTs)
Overall Response Rate (ORR)
Secondary outcome measures
Antibodies to cemiplimab
Antibodies to isatuximab
Assessment of PK parameter: Cmax
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Isatuximab/cemiplimab (Regimen 2)Experimental Treatment2 Interventions
Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Day 1 in 28-day cycle up to disease progression.
Group II: Isatuximab/cemiplimab (Regimen 1)Experimental Treatment2 Interventions
Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression. Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.
Group III: IsatuximabActive Control1 Intervention
Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab SAR650984
2015
Completed Phase 2
~580
Cemiplimab REGN2810
2018
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,871 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,092 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,729 Total Patients Enrolled
22 Trials studying Multiple Myeloma
4,094 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate number of participants enrolled in this experiment?

"At this time, no more candidates are being accepted for this trial. It was initially posted on January 25th 2018 and the data was last updated October 12th 2022. If you're in search of other medical studies, 818 trials related to neoplasms or plasma cells are presently recruiting patients as well as 100 trials specifically dedicated to Isatuximab SAR650984."

Answered by AI

What clinical advantages does Isatuximab SAR650984 offer?

"alK gene mutation can be managed with Isatuximab SAR650984, which has also been found to treat conditions such as pre-existing medical directives and malignant neoplasms. It is especially beneficial for patients who have attempted other treatments like lenalidomide or proteasome inhibitor therapies before."

Answered by AI

What further experiments have been conducted regarding Isatuximab SAR650984?

"Isatuximab SAR650984 was initially studied in City of Hope during the year 2010. 11 clinical trials have been completed and there are 100 active studies, many of which take place in Montreal and Pennsylvania."

Answered by AI

Are there any enrolment opportunities for this trial at present?

"Information available on clinicaltrials.gov states that this medical trial is not taking applications at the current time, even though it was initially posted in January 2018 and last updated October 12th 2022. Nevertheless, there are over 900 other studies looking for participants right now."

Answered by AI

What goals are researchers hoping to achieve through this investigation?

"The primary purpose of this trial, assessed over a period spanning up to 4 weeks, is to analyse Adverse Events (AEs) and changes in laboratory tests and vital signs. Secondary goals include measuring Antibodies to cemiplimab levels in the blood serum samples; calculating Duration of Response (DOR); as well as determining amount of anti-isatuximab antibodies present in plasma specimens."

Answered by AI

In what areas can one seek out this research-based endeavor?

"Currently, this medical trial is available at 7 different sites, located in Montreal, Sherbrooke and Philadelphia as well as other locations. To reduce any travel needs associated with participation, it would be beneficial to select the closest clinic."

Answered by AI
~15 spots leftby Apr 2025