A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Официальное название

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

Обзор

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Вмешательства

• Препарат Cilta-cel
  Cilta-cel will be administered as intravenous infusion.
• Препарат Cyclophosphamide
  Cyclophosphamide will be administered as intravenous infusion.
• Препарат Induction therapy
  Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.
• Препарат Fludarabine
  Fludarabine will be administered as intravenous infusion.

Первичные конечные точки

• Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion [Срок оценки: At least 12 months after Cilta-cel infusion on Day 1]

Вторичные конечные точки (9)

• Overall MRD-negative CR Rate [Срок оценки: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)]
• CR or better status [Срок оценки: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)]
• Progression Free Survival (PFS) [Срок оценки: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)]
• Overall Survival (OS) [Срок оценки: Up to 3 years and 4 months]
• Number of Participants with Adverse Event (AE) by Severity [Срок оценки: Up to 3 years and 4 months]
• Number of Participants with Abnormalities in Laboratory Parameters [Срок оценки: Up to 3 years and 4 months]
• Levels of Cilta-cel T-Cell Expansion, and Persistence [Срок оценки: Up to 3 years and 4 months]
• Number of Participants with Anti-Cilta-Cel Antibodies [Срок оценки: Up to 3 years and 4 months]
• Percentage of Participants with Presence of Replication-competent Lentivirus (RCL) [Срок оценки: Up to 3 years and 4 months]

Критерии участия

Критерии включения

• Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (>=)1.0 grams per deciliter (g/dL) or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain >= 10 mg/dL and abnormal serum free light chain ratio
• Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
• Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled
• Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
• Must be willing and able to adhere to the lifestyle restrictions specified in the protocol

Критерии исключения

• Frailty index of >= 2 according to Myeloma Geriatric Assessment score
• Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
• Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
• Participants who require continuous supplemental oxygen

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 8 центров

• Hosp. Univ. Germans Trias I Pujol — Badalona
• Hosp Univ Vall D Hebron — Barcelona
• Hosp. Clinic de Barcelona — Barcelona
• Hosp. Univ. 12 de Octubre — Madrid
• Clinica Univ. de Navarra — Pamplona
• Hosp Clinico Univ de Salamanca — Salamanca
• Hosp. Univ. Marques de Valdecilla — Santander
• Hosp. Virgen Del Rocio — Seville

США · 5 центров

• University of California San Francisco — San Francisco
• Moffitt Cancer Center — Tampa
• University of Iowa Hospital and Clinics — Iowa City
• Memorial Sloan Kettering Cancer Center — New York
• Cleveland Clinic — Cleveland

Австралия · 4 центра

• Royal Prince Alfred Hospital — Camperdown
• Austin Hospital — Heidelberg
• Fiona Stanley Hospital — Murdoch
• Princess Alexandra Hospital — Woolloongabba

Идентификаторы

NCT: NCT07149857 · 68284528MMY2012 · 68284528MMY2012 · 2025-521975-30-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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