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Monoclonal Antibodies

Isatuximab for Multiple Myeloma

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of giving signed informed consent.

Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 42 months

Awards & highlights

Study Summary

This trial offers continued access to isatuximab for adults with multiple myeloma, and assesses the long-term safety of this treatment.

Who is the study for?

Adults with multiple myeloma who've benefited from isatuximab in earlier phases of the trial can join. They must be over 18, not pregnant or breastfeeding, use double contraception methods, and have completed previous study objectives. Those still benefiting as judged by their doctor are eligible.Check my eligibility

What is being tested?

This Phase 2 extension study tests long-term safety of isatuximab for multiple myeloma patients post-completion of prior studies. It offers continued access to isatuximab either alone or combined with other drugs like dexamethasone and lenalidomide.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site for Isatuximab SC/IV, increased risk of infections, potential blood disorders, fatigue, and skin reactions related to Cemiplimab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and sign the consent form.

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I am at least 18 years old or the legal age of consent where the study is conducted.

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I completed a previous study on isatuximab alone or with other treatments.

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I am using two forms of birth control and am not pregnant or breastfeeding. I will not donate sperm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 42 months 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 participants with treatment-emergent adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: IsatuximabExperimental Treatment6 Interventions

Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the patient received on the parental protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

Pomalidomide

2011

Completed Phase 2

~1020

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,910 Total Patients Enrolled

47 Trials studying Multiple Myeloma

10,131 Patients Enrolled for Multiple Myeloma

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,768 Total Patients Enrolled

22 Trials studying Multiple Myeloma

4,133 Patients Enrolled for Multiple Myeloma

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05669989 — Phase 2

Multiple Myeloma Research Study Groups: Isatuximab

Multiple Myeloma Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT05669989 — Phase 2

Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669989 — Phase 2

Frequently Asked Questions

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

Has Isatuximab been sanctioned by the FDA?

"Isatuximab's safety record is rated as a two due to the lack of evidence supporting its effectiveness. This assessment comes from Phase 2 trials that have generated some data regarding the drug's risk profile."

Answered by AI

Are recruitment efforts still underway for this research endeavor?

"According to the records hosted on clinicaltrials.gov, this medical study is actively recruiting participants; it was first made available for public viewing on April 5th 2023 and recently modified on July 7th 2023."

Answered by AI

How many participants is the study recruiting?

"Affirmative. Evident from the information on clinicaltrials.gov, this experiment is presently recruiting individuals and was initially posted on April 5th 2023. This trial needs around 70 volunteers to be sourced from 12 healthcare facilities."

Answered by AI

Are there any American hospitals participating in the trial of this medical intervention?

"Patients may choose from 12 different clinical sites to participate in the trial. These include Investigational Site Number: 7520004 located in Luleå, Okayama-shi's 3920001 site and Washington University School of Medicine -Site Number 8400001 situated at Saint Louis, plus an additional 9 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

2023. "International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669989.