Clinical trial NCT05669989: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Plasma Cell Myeloma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-01-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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 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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events
timeFrame: Baseline to 42 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University- Site Number : 8400001
state: Missouri
city: Blacktown
country: Australia
facility: Investigational Site Number : 0360006
state: New South Wales
city: Saint Leonards
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Wollongong
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360004
state: Victoria
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360005
state: Victoria
city: Richmond
country: Australia
facility: Investigational Site Number : 0360002
state: Victoria
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus- Site Number : 0760003
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001
city: Temuco
country: Chile
facility: Investigational Site Number : 1520001
city: Tianjin
country: China
facility: Investigational Site Number : 1560001
city: Brno
country: Czechia
facility: Investigational Site Number : 2030002
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030003
city: Prague
country: Czechia
facility: Investigational Site Number : 2030001
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460001
city: Nantes
country: France
facility: Investigational Site Number : 2500002
city: Athens
country: Greece
facility: Investigational Site Number : 3000004
city: Athens
country: Greece
facility: Investigational Site Number : 3000003
city: Patras
country: Greece
facility: Investigational Site Number : 3000001
city: Torino
country: Italy
facility: Investigational Site Number : 3800002
city: Okayama
country: Japan
facility: Investigational Site Number : 3920001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Auckland
country: New Zealand
facility: Investigational Site Number : 5540002
city: Wellington
country: New Zealand
facility: Investigational Site Number : 5540001
city: Kirov
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Seville
country: Spain
facility: Investigational Site Number : 7240006
state: Andalucia
city: Santander
country: Spain
facility: Investigational Site Number : 7240004
state: Cantabria
city: Badalona
country: Spain
facility: Investigational Site Number : 7240005
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Investigational Site Number : 7241001
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240001
state: Navarra
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Salamanca
country: Spain
facility: Investigational Site Number : 7240002
city: Luleå
country: Sweden
facility: Investigational Site Number : 7520004
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: