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Clinical Trials in Czechia / NCT05669989
Enrolling by invitation Phase 2

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

NCT05669989 · tracked via the Priya Life Science Czechia tracker
Sponsor
Phase
Phase 2
Started
2023-04-05
Last updated
2026-07-31

Condition(s) studied

Plasma Cell Myeloma

Investigational drug(s) / intervention(s)

Isatuximab intravenous (IV) →Cemiplimab (SAR439684) →Dexamethasone →Lenalidomide →Pomalidomide →Isatuximab subcutaneous (SC) →Carfilzomib →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Washington University- Site Number : 8400001 St Louis Missouri
Investigational Site Number : 0360006 Blacktown New South Wales
Investigational Site Number : 0360001 Saint Leonards New South Wales
Investigational Site Number : 0360003 Wollongong New South Wales
Investigational Site Number : 0360004 Melbourne Victoria
Investigational Site Number : 0360005 Melbourne Victoria
Investigational Site Number : 0360002 Richmond Victoria
Hospital Mae de Deus- Site Number : 0760003 Porto Alegre Rio Grande do Sul
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002 São Paulo São Paulo
Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001 Rio de Janeiro Brazil
Investigational Site Number : 1520001 Temuco Chile
Investigational Site Number : 1560001 Tianjin China
Investigational Site Number : 2030002 Brno Czechia
Investigational Site Number : 2030003 Ostrava Czechia
Investigational Site Number : 2030001 Prague Czechia
Investigational Site Number : 2460001 Helsinki Finland
Investigational Site Number : 2500002 Nantes France
Investigational Site Number : 3000004 Athens Greece
Investigational Site Number : 3000003 Athens Greece
Investigational Site Number : 3000001 Pátrai Greece
Investigational Site Number : 3800002 Torino Italy
Investigational Site Number : 3920001 Okayama Japan
Investigational Site Number : 5540002 Auckland New Zealand
Investigational Site Number : 5540001 Wellington New Zealand
Investigational Site Number : 6430002 Kirov Russia
Investigational Site Number : 6430001 Moscow Russia
Investigational Site Number : 4100001 Seoul Seoul-teukbyeolsi
Investigational Site Number : 4100002 Seoul Seoul-teukbyeolsi
Investigational Site Number : 7240006 Seville Andalusia
Investigational Site Number : 7240004 Santander Cantabria
Investigational Site Number : 7240005 Badalona Catalunya [Cataluña]
Investigational Site Number : 7241001 Madrid Madrid, Comunidad de
Investigational Site Number : 7240001 Pamplona Navarre
Investigational Site Number : 7240003 Madrid Spain
Investigational Site Number : 7240002 Salamanca Spain
Investigational Site Number : 7520004 Luleå Sweden
Investigational Site Number : 1580001 Taichung Taiwan

On this site

📄 Revlimid (lenalidomide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05669989 on ClinicalTrials.gov ↗ ← All trials in Czechia