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Active (not recruiting) Phase 2 NCT05669989

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

Phase 2 – studying effectiveness and dosage
Conditions: Plasma Cell Myeloma

Sponsor: Sanofi

trial.available_in: БГ
Overview
* 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.
Who can participate
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.
Locations 17
Australia (1)
Investigational Site Number : 0360006
Blacktown , New South Wales
Brazil (1)
Hospital Mae de Deus- Site Number : 0760003
Porto Alegre , Rio Grande do Sul
Chile (1)
Investigational Site Number : 1520001
Temuco
China (1)
Investigational Site Number : 1560001
Tianjin
Czech Republic (1)
Investigational Site Number : 2030002
Brno
Finland (1)
Investigational Site Number : 2460001
Helsinki
France (1)
Investigational Site Number : 2500002
Nantes
Greece (1)
Investigational Site Number : 3000004
Athens
Italy (1)
Investigational Site Number : 3800002
Torino
Japan (1)
Investigational Site Number : 3920001
Okayama
New Zealand (1)
Investigational Site Number : 5540002
Auckland
Russia (1)
Investigational Site Number : 6430002
Kirov
South Korea (1)
Investigational Site Number : 4100001
Seoul , Seoul-teukbyeolsi
Spain (1)
Investigational Site Number : 7240006
Seville , Andalusia
Sweden (1)
Investigational Site Number : 7520004
Luleå
Taiwan (1)
Investigational Site Number : 1580001
Taichung
United States (1)
Washington University- Site Number : 8400001
St Louis , Missouri
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
05.04.2023
Completion date
30.11.2026
Registry ID
NCT05669989
Source
anzctr
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