A Study Comparing Anitocabtagen-Autoleucel with Standard Therapy in Participants with Relapsed/Refractory Multiple Myeloma
Descrizione riassuntiva dello studio
In this study, the investigational drug Anitocabtagen-Autoleucel (referred to as Anito-Cel) is compared with established standard therapies (chemo-immunotherapies) for the treatment of multiple myeloma. Participants will receive either Anito-Cel or the standard therapy. The treatment investigated in this study is made using so-called T-cells, a type of your own white blood cells. These cells are taken from the participants, modified to target cancer cells, and then re-administered to the participants. The treatment is administered once intravenously. We are investigating in this study whether the investigational drug Anito-Cel is effective and well-tolerated in the treatment of multiple myeloma. The study includes two treatment groups: the Anito-Cel group (investigational drug group) and the standard therapy group. The treatment in the Anito-Cel group involves the collection of white blood cells for the production of Anito-Cel, three days of chemotherapy as lymphodepletion to prepare for receiving Anito-Cel, and then a single infusion of Anito-Cel. For participants with rapidly progressing cancer, a bridging therapy may be administered during the production of Anito-Cel if necessary to keep the disease under control. This bridging therapy would consist of a short-term administration of one of the four standard therapies described below. The treatment in the standard therapy group includes the following four standard therapies, from which the investigator will select the most appropriate treatment: • Pomalidomide, Bortezomib, and Dexamethasone (PVd) • Daratumumab, Pomalidomide, Dexamethasone (DPd) • Carfilzomib, Daratumumab, Dexamethasone (KDd) • Carfilzomib and Dexamethasone (Kd) The probability of receiving Anito-Cel or the standard therapy is 50% for each.
(BASEC)
Intervento studiato
The study includes two treatment groups: the Anito-Cel group (investigational drug group) and the standard therapy group.
The treatment in the Anito-Cel group involves the collection of white blood cells for the production of Anito-Cel, three days of chemotherapy as lymphodepletion to prepare for receiving Anito-Cel, and then a single infusion of Anito-Cel. For participants with rapidly progressing cancer, a bridging therapy may be administered during the production of Anito-Cel if necessary to keep the disease under control. This bridging therapy would consist of a short-term administration of one of the four standard therapies described below.
The treatment in the standard therapy group includes the following four standard therapies, from which the investigator will select the most appropriate treatment for you (the investigator will explain these treatments to you in detail):
• Pomalidomide, Bortezomib, and Dexamethasone (PVd)
• Daratumumab, Pomalidomide, Dexamethasone (DPd)
• Carfilzomib, Daratumumab, Dexamethasone (KDd)
• Carfilzomib and Dexamethasone (Kd)
(BASEC)
Malattie studiate
relapsed/refractory multiple myeloma
(BASEC)
- Documented diagnosis of multiple myeloma (MM) in the medical history - 1 to 3 prior lines of anti-myeloma therapy - Documented evidence of progressive disease, based on the investigator's assessment at or within 12 months after the last dose of the last therapy - Measurable disease at the screening examination (BASEC)
Criteri di esclusione
- prior B-cell maturation antigen (BCMA)-targeted therapy - prior T-cell engager therapy - prior CAR-T therapy or other genetically modified T-cell therapy - Active or previous involvement of the central nervous system (CNS) or meninges in MM - Involvement of MM in the heart atrium or ventricle (BASEC)
Luogo dello studio
Berna, Losanna
(BASEC)
Sponsor
Gilead Sciences, Switzerléand
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Thomas Pabst
+41 (0) 31 632 41 14
thomas.pabst@clutterinsel.chInselspital, Onkologie
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
16.12.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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