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SAR442085 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 approximately 12 months after the last patient has started treatment in part b (approx. 2 years)

Awards & highlights

Study Summary

This trial is testing a new drug, SAR442085, for patients with relapsed or refractory multiple myeloma who have failed other treatments. The goal is to find the maximum tolerated dose and to assess the safety and efficacy of the drug.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months after the last patient has started treatment in part b (approx. 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months after the last patient has started treatment in part b (approx. 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months after the last patient has started treatment in part b (approx. 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall response rate (Part B)

Recommended Phase 2 dose (RP2D) (Part A)

The maximum tolerated dose (MTD) of SAR442085 (Part A)

Secondary outcome measures

Anti-drug antibody (ADA) against SAR442085 (Both Part A and B)

Duration of response (Part B)

PK parameters of SAR442085: AUC (Both Part A and B)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: SAR442085 dose expansionExperimental Treatment1 Intervention

SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration.

Group II: Part A: SAR442085 dose escalationExperimental Treatment1 Intervention

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Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,943 Total Patients Enrolled

47 Trials studying Multiple Myeloma

10,164 Patients Enrolled for Multiple Myeloma

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,801 Total Patients Enrolled

22 Trials studying Multiple Myeloma

4,166 Patients Enrolled for Multiple Myeloma

Media Library

SAR442085 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04000282 — Phase 1

Multiple Myeloma Research Study Groups: Part A: SAR442085 dose escalation, Part B: SAR442085 dose expansion

Multiple Myeloma Clinical Trial 2023: SAR442085 Highlights & Side Effects. Trial Name: NCT04000282 — Phase 1

SAR442085 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04000282 — Phase 1

Frequently Asked Questions

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

Are there any vacancies in this research endeavor for participants?

"Per clinicaltrials.gov, this medical trial is no longer accepting new participants as it was last updated on September 13th 2022 and first posted in August of 2019. However, at the moment 818 other trials are still actively recruiting patients."

Answered by AI

What are the core goals of this research endeavor?

"The study sponsor, Sanofi, has identified Overall response rate (Part B) as the primary outcome to be measured over a 28 day cycle. Secondary outcomes for monitoring include Anti-drug antibody (ADA) against SAR442085 (Both Part A and B), PK parameters of SAR442085: AUC (Both Part A and B), and Treatment-emergent adverse events/serious adverse events (TEAEs / SAE; Both Part A and B)."

Answered by AI

To what extent could SAR442085 pose a risk to patients?

"There is only limited evidence for SAR442085's safety and efficacy, so it was granted a score of 1."

Answered by AI

Are there multiple centers that are trialing this research in Canada?

"This patient recruitment is being conducted at 15 clinical trial sites. Rochester, Minnesota (8400002), Chapel Hill, North carolina (8400005) and Boston, Massachusetts (8400006) are some of the major locations involved in this study as well as 11 other medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

2019. "First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04000282.