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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1277-6635 | Registry Identifier | ICTRP | |
| 2023-507180-19 | Registry Identifier | CTIS | |
| 2022-002253-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isatuximab | Experimental | Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab intravenous (IV) | Drug | Route of administration: IV infusion; Pharmaceutical form: Vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Baseline to 42 months |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University- Site Number : 8400001 | St Louis | Missouri | 63110 | United States | ||
| Investigational Site Number : 0360006 |
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| Label | URL |
|---|---|
| LTS17704 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Cemiplimab (SAR439684) | Drug | Route of administration: IV infusion; Pharmaceutical form: Vial |
|
| Dexamethasone | Drug | Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial |
|
| Lenalidomide | Drug | Route of administration: Oral; Pharmaceutical form: Capsules |
|
| Pomalidomide | Drug | Route of administration: Oral; Pharmaceutical form: Hard capsules |
|
| Isatuximab subcutaneous (SC) | Drug | Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial |
|
|
| Carfilzomib | Drug | Route of administration: IV infusion; Pharmaceutical form: Vial |
|
| Blacktown |
| New South Wales |
| 2148 |
| Australia |
| Investigational Site Number : 0360001 | Saint Leonards | New South Wales | 2065 | Australia |
| Investigational Site Number : 0360003 | Wollongong | New South Wales | 2500 | Australia |
| Investigational Site Number : 0360004 | Melbourne | Victoria | 3065 | Australia |
| Investigational Site Number : 0360005 | Melbourne | Victoria | 3084 | Australia |
| Investigational Site Number : 0360002 | Richmond | Victoria | 3121 | Australia |
| Hospital Mae de Deus- Site Number : 0760003 | Porto Alegre | Rio Grande do Sul | 90880-480 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002 | São Paulo | São Paulo | 05403-010 | Brazil |
| Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001 | Rio de Janeiro | 22775-001 | Brazil |
| Investigational Site Number : 1520001 | Temuco | 4780000 | Chile |
| Investigational Site Number : 1560001 | Tianjin | 300020 | China |
| Investigational Site Number : 2030002 | Brno | 625 00 | Czechia |
| Investigational Site Number : 2030003 | Ostrava | 708 52 | Czechia |
| Investigational Site Number : 2030001 | Prague | 128 08 | Czechia |
| Investigational Site Number : 2460001 | Helsinki | 00029 | Finland |
| Investigational Site Number : 2500002 | Nantes | 44093 | France |
| Investigational Site Number : 3000004 | Athens | 106 76 | Greece |
| Investigational Site Number : 3000003 | Athens | 115 28 | Greece |
| Investigational Site Number : 3000001 | Pátrai | 265 04 | Greece |
| Investigational Site Number : 3800002 | Torino | 10126 | Italy |
| Investigational Site Number : 3920001 | Okayama | 701-1192 | Japan |
| Investigational Site Number : 5540002 | Auckland | 2025 | New Zealand |
| Investigational Site Number : 5540001 | Wellington | 6021 | New Zealand |
| Investigational Site Number : 6430002 | Kirov | 610027 | Russia |
| Investigational Site Number : 6430001 | Moscow | 125284 | Russia |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 06591 | South Korea |
| Investigational Site Number : 7240006 | Seville | Andalusia | 41013 | Spain |
| Investigational Site Number : 7240004 | Santander | Cantabria | 39008 | Spain |
| Investigational Site Number : 7240005 | Badalona | Catalunya [Cataluña] | 08916 | Spain |
| Investigational Site Number : 7241001 | Madrid | Madrid, Comunidad de | 28027 | Spain |
| Investigational Site Number : 7240001 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number : 7240003 | Madrid | 28041 | Spain |
| Investigational Site Number : 7240002 | Salamanca | 37007 | Spain |
| Investigational Site Number : 7520004 | Luleå | 971 80 | Sweden |
| Investigational Site Number : 1580001 | Taichung | 404 | Taiwan |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000599209 | isatuximab |
| C000627974 | cemiplimab |
| D003907 | Dexamethasone |
| D000077269 | Lenalidomide |
| C467566 | pomalidomide |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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