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Corticosteroid

isatuximab SAR650984 for Multiple Myeloma

Phase 1

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 9 months from the last investigational medicinal product (imp)/non-imp (nimp) administration

Awards & highlights

Study Summary

This trial is testing a new combination drug therapy for people with relapsed or refractory multiple myeloma. The primary objective is to determine the maximum tolerated dose of the new drug, SAR650984 (isatuximab), in combination with lenalidomide and dexamethasone. The secondary objectives are to assess the safety and efficacy of the combination therapy, as well as the pharmacokinetics of the new drug.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months from the last investigational medicinal product (imp)/non-imp (nimp) administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months from the last investigational medicinal product (imp)/non-imp (nimp) administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months from the last investigational medicinal product (imp)/non-imp (nimp) administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with adverse events when treated with SAR650984 (isatuximab) in combination with LD

Secondary outcome measures

Assessment of PK parameters - area under the plasma concentration versus time curve over the dosing interval (AUCtau)

Assessment of PK parameters - concentration observed at end of infusion (Ceoi)

Assessment of PK parameters - maximum concentration (Cmax)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAR650984 (isatuximab)Experimental Treatment3 Interventions

SAR650984 (isatuximab) (escalating dose) plus lenalidomide 25 mg on Days 1 to 21 plus dexamethasone 40 mg on Days 1, 8, 15, 22 in 28-day cycles for all cohorts up to disease progression. For Q2W cohorts: SAR650984 (isatuximab) on Days 1 and 15 of every cycle. For QW/Q2W cohorts: SAR650984 (isatuximab) on Days 1, 8, 15, and 22 of first cycle and Days 1 and 15 of every subsequent cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

isatuximab SAR650984

2013

Completed Phase 1

~150

dexamethasone

1995

Completed Phase 3

~9860

lenalidomide

2012

Completed Phase 3

~3920

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,923 Total Patients Enrolled

47 Trials studying Multiple Myeloma

10,144 Patients Enrolled for Multiple Myeloma

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,782 Total Patients Enrolled

22 Trials studying Multiple Myeloma

4,146 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.

In which geographical areas does this clinical experimentation take place?

"Currently, this medical research is running at 5 locations that are dispersed across the United States. These include San Francisco, Saint Louis and Columbus amongst other cities. If you plan to join, it would be wise to pick a centre closest to your residence in order to minimize travel costs."

Answered by AI

Are investigators still welcoming participants for this clinical experiment?

"According to the information present on clinicaltrials.gov, this trial is not presently recruiting candidates for enrollment. Initially posted in February 2013 and last refreshed June 16th 2022, it appears that no new patients are being sought at this time; however there are 1,529 other trials actively seeking participants."

Answered by AI

What other investigations have been performed around the impact of isatuximab SAR650984?

"Since its inception in 2002, isatuximab SAR650984 has gone through 1342 clinical trials. Moreover, there are currently 711 active studies being conducted around the world - San Francisco houses a large proportion of these initiatives."

Answered by AI

How many participants are engaged in this research?

"This clinical trial has closed its recruitment period, as the last edit on clinicaltrials.gov was dated June 16th 2022. If you are searching for alternative studies, there are currently 818 trials involving multiple myeloma and 711 trials that focus on isatuximab SAR650984 with open enrolment."

Answered by AI

Are there any risks associated with using isatuximab SAR650984 therapeutically?

"Our team at Power believes the safety of isatuximab SAR650984 to be low, scoring a 1 on our scale. This is due to its Phase 1 status; limited data exists supporting both efficacy and safety."

Answered by AI

What therapeutic effects is isatuximab SAR650984 commonly employed for?

"Isatuximab SAR650984 provides therapeutic options for sufferers of ophthalmia, sympathetic syndrome, having experienced a minimum of 2 systemic chemotherapies, and branch retinal vein occlusion."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Individualized Genetic Makeup That Controls Natural Killer Cell Function Influences the Efficacy of Isatuximab Immunotherapy in Patients with Multiple Myeloma

Sun, Haibo, Thomas G Martin, John Marra, Denice Kong, Jonathon Keats, Sandrine Macé, Marielle Chiron, Jeffrey L Wolf, Jeffrey M Venstrom, and Raja Rajalingam. 2021. “Individualized Genetic Makeup That Controls Natural Killer Cell Function Influences the Efficacy of Isatuximab Immunotherapy in Patients with Multiple Myeloma”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-002958.

BloodJournal

A Phase 1b Study of Isatuximab Plus Lenalidomide and Dexamethasone for Relapsed/refractory Multiple Myeloma

Martin, Thomas, Rachid Baz, Don M. Benson, Nikoletta Lendvai, Jeffrey Wolf, Pamela Munster, Alexander M. Lesokhin, et al.. 2017. “A Phase 1b Study of Isatuximab Plus Lenalidomide and Dexamethasone for Relapsed/refractory Multiple Myeloma”. Blood. American Society of Hematology. doi:10.1182/blood-2016-09-740787.

clinicaltrials.govStudy

SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

2013. "SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01749969.