A Study Comparing Anitocabtagen-Autoleucel with Standard Therapy in Participants with Relapsed/Refractory Multiple Myeloma
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Bern, Lausanne
(BASEC)
Sponsor
Gilead Sciences, Switzerléand
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Thomas Pabst
+41 (0) 31 632 41 14
thomas.pabst@clutterinsel.chInselspital, Onkologie
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.12.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ergebnisse der Studie
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