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

Primary Purpose

Plasma Cell Myeloma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Isatuximab IV (SAR650984)
Cemiplimab (SAR439684)
Dexamethasone
Lenalidomide
Pomalidomide
Isatuximab SC (SAR650984)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasma Cell Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed. Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A patient not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included. Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants. Capable of giving signed informed consent. Exclusion Criteria: Participant has evidence of progressive disease during or at the time of the parental study closure. Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study. As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. Any country-related specific regulation that would prevent the participant from entering the study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sites / Locations

  • Washington University School of Medicine-Site Number:8400001Recruiting
  • Investigational Site Number :0360001Recruiting
  • Investigational Site Number :0760001Recruiting
  • Investigational Site Number :1520001
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :2460001
  • Investigational Site Number :2500002Recruiting
  • Investigational Site Number :2760001Recruiting
  • Investigational Site Number :3000001Recruiting
  • Investigational Site Number :3920001Recruiting
  • Investigational Site Number :4100001Recruiting
  • Investigational Site Number :6430001
  • Investigational Site Number :7240004Recruiting
  • Investigational Site Number :7241001Recruiting
  • Investigational Site Number :7240001Recruiting
  • Investigational Site Number :7240003Recruiting
  • Investigational Site Number :7240002Recruiting
  • Investigational Site Number :7520004Recruiting
  • Investigational Site Number :1580001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Isatuximab

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
September 21, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05669989
Brief Title
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
Official Title
International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 14, 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
September 21, 2026 (Anticipated)
Study Completion Date
September 21, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center, open-label, Phase 2 treatment extension study in patients with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. The primary objective of the study is to assess long-term safety of isatuximab as study treatment.
Detailed Description
Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isatuximab
Arm Type
Experimental
Arm Description
Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the patient received on the parental protocol
Intervention Type
Drug
Intervention Name(s)
Isatuximab IV (SAR650984)
Other Intervention Name(s)
SARCLISA®
Intervention Description
Route of administration: IV infusion Pharmaceutical form: Vial
Intervention Type
Drug
Intervention Name(s)
Cemiplimab (SAR439684)
Intervention Description
Route of administration: IV infusion Pharmaceutical form: Vial
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Route of administration: Oral Pharmaceutical form: Tablets
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Route of administration: Oral Pharmaceutical form: Capsules
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Route of administration: Oral Pharmaceutical form: Hard capsules
Intervention Type
Drug
Intervention Name(s)
Isatuximab SC (SAR650984)
Other Intervention Name(s)
SARCLISA®
Intervention Description
Route of administration: SC injection with the investigational isatuximab injector device Pharmaceutical form: Vial
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events
Time Frame
Baseline to 42 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed. Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A patient not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included. Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants. Capable of giving signed informed consent. Exclusion Criteria: Participant has evidence of progressive disease during or at the time of the parental study closure. Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study. As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. Any country-related specific regulation that would prevent the participant from entering the study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Washington University School of Medicine-Site Number:8400001
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360001
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760001
City
Rio De Janeiro
ZIP/Postal Code
22775-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :1560001
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2460001
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :2500002
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Patra
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :7240004
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7241001
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7520004
City
Luleå
ZIP/Postal Code
97180
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580001
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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