International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of participants with treatment-emergent adverse events — Baseline to 42 months
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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Other trials for the same condition
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 South Korea