Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

Официальное название

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy

Обзор

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

Вмешательства

• Препарат Cevostamab
  Participants will receive cevostamab IV as per the schedule given in the protocol.
• Препарат Pomalidomide
  Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol.
• Препарат Dexamethasone
  Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol.
• Препарат Daratumumab
  Participants will receive daratumumab SC as per the schedule given in the protocol.
• Препарат Elotuzumab
  Participants will receive elotuzumab IV as per the schedule given in the protocol.
• Препарат Carfilzomib
  Participants will receive carfilzomib IV as per the schedule given in the protocol.

Первичные конечные точки

• Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate [Срок оценки: Up to 1 year after the last participant is randomized]
• Progression-Free Survival (PFS) [Срок оценки: Up to 5 years after the last participant is randomized]

Вторичные конечные точки (12)

• Very Good Partial Response (VGPR) or Better Rate [Срок оценки: Up to 5 years after the last participant is randomized]
• Overall Survival (OS) [Срок оценки: Up to 5 years after the last participant is randomized]
• Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20) [Срок оценки: Up to 5 years after the last participant is randomized]
• Overall Response Rate (ORR) [Срок оценки: Up to 5 years after the last participant is randomized]
• Complete Response (CR) Rate [Срок оценки: Up to 5 years after the last participant is randomized]
• Time to Response (TTR) [Срок оценки: Up to 5 years after the last participant is randomized]
• Time to Best Response (TTBR) [Срок оценки: Up to 5 years after the last participant is randomized]
• Duration of Response (DOR) [Срок оценки: Up to 5 years after the last participant is randomized]
• Progression-Free Survival (PFS) [Срок оценки: Up to 5 years after the last participant is randomized]
• Progression-Free Survival 2 (PFS2) [Срок оценки: Up to 5 years after the last participant is randomized]
• Overall MRD-Negative Complete Response Rate [Срок оценки: Up to 5 years after the last participant is randomized]
• Overall MRD-Negative Rate [Срок оценки: Up to 5 years after the last participant is randomized]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
• Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
• MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
• Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
• Participants must have measurable disease during screening

Критерии исключения

• Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
• Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/liter (L) or 5% of the peripheral blood white cells
• GI disease that might significantly alter absorption of oral drugs
• Participants must not have any ongoing CNS disease or non-secretory myeloma

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• City of Hope National Medical Center — Duarte
• City of Hope - Lennar Foundation Cancer Center — Irvine
• Emory University Hospital Midtown — Atlanta
• Novant Health Cancer Institute — Charlotte
• Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists — Winston-Salem
• TriHealth Cancer and Blood Institute — Cincinnati

Япония · 4 центра

• Nagoya City University Hospital — Aichi
• University Hospital Kyoto Prefectural University of Medicine — Kyoto
• The Cancer Institute Hospital of JFCR — Tokyo
• Yamagata University Hospital — Yamagata

South Korea · 4 центра

• Chonnam National University Hwasun Hospital — Jeollanam-do
• Seoul National University Hospital — Seoul
• Asan Medical Center — Seoul
• Seoul St Mary's Hospital — Seoul

Пуэрто-Рико · 1 центр

• Auxilio Mutuo Cancer Center — San Juan

Идентификаторы

NCT: NCT07555938 · CO46096 · 2025-524028-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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