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

Plasma Cell Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669989
• Other study ID #: LTS17704
• Secondary ID: U1111-1277-66352
• Status: Recruiting
• Phase: Phase 2
• Start date: April 5, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• This is a multi-center, open-label, Phase 2 treatment extension study in participants 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 participant 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Drug:
• Isatuximab intravenous (IV)
Route of administration: IV infusion; Pharmaceutical form: Vial
• Cemiplimab (SAR439684)
Route of administration: IV infusion; Pharmaceutical form: Vial
• Dexamethasone
Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial
• Lenalidomide
Route of administration: Oral; Pharmaceutical form: Capsules
• Pomalidomide
Route of administration: Oral; Pharmaceutical form: Hard capsules
• Isatuximab subcutaneous (SC)
Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial
• Carfilzomib
Route of administration: IV infusion; Pharmaceutical form: Vial

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360004	Fitzroy	Victoria
Australia	Investigational Site Number : 0360002	Richmond	Victoria
Australia	Investigational Site Number : 0360001	St Leonards	New South Wales
Australia	Investigational Site Number : 0360003	Wollongong	New South Wales
Brazil	Instituto COI de Educacao e Pesquisa Site Number : 0760001	Rio De Janeiro
Chile	Investigational Site Number : 1520001	Temuco
China	Investigational Site Number : 1560001	Tianjin
Czechia	Investigational Site Number : 2030001	Praha 2
Finland	Investigational Site Number : 2460001	Helsinki
France	Investigational Site Number : 2500002	Nantes
Greece	Investigational Site Number : 3000001	Patra
Italy	Investigational Site Number : 3800002	Torino
Japan	Investigational Site Number : 3920001	Okayama-shi	Okayama
Korea, Republic of	Investigational Site Number : 4100001	Seoul	Seoul-teukbyeolsi
Russian Federation	Investigational Site Number : 6430001	Moscow
Spain	Investigational Site Number : 7240003	Madrid
Spain	Investigational Site Number : 7241001	Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240001	Pamplona	Navarra
Spain	Investigational Site Number : 7240002	Salamanca
Spain	Investigational Site Number : 7240004	Santander	Cantabria
Sweden	Investigational Site Number : 7520004	Luleå
Taiwan	Investigational Site Number : 1580001	Taichung
United States	Washington University School of Medicine Site Number : 8400001	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Chile,  China,  Czechia,  Finland,  France,  Greece,  Italy,  Japan,  Korea, Republic of,  Russian Federation,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events		Baseline to 42 months