A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Официальное название

A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Обзор

The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and/or improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.

Подробное описание

This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 \[28 days\] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and minimal residual disease (MRD) negativity rate.

Вмешательства

• Препарат SCTC21C
  Pharmaceutical form: Solution for infusion； Route of administration: Subcutaneous
• Препарат Bortezomib
  Pharmaceutical form: Lyophilized powder for injection； Route of administration: Subcutaneous
• Препарат Lenalidomide
  Pharmaceutical form: Capsules； Route of administration: Oral
• Препарат Dexamethasone
  Pharmaceutical form: Tablets, ampoules or vials for injection； Route of administration: Oral/Intravenous

Первичные конечные точки

• Progression free survival (PFS) [Срок оценки: Up to approximately 84 months after the First Participant In (FPI)]
• Minimal residual disease (MRD) negativity rate for participants with CR [Срок оценки: Up to approximately 84 months after the FPI]

Вторичные конечные точки (3)

• Overall response rate (ORR) [Срок оценки: Up to approximately 84 months after the FPI]
• Duration of response (DOR) [Срок оценки: Up to approximately 84 months after the FPI]
• Adverse Events [Срок оценки: Up to approximately 84 months after the FPI]

Критерии участия

Критерии включения

• Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.
• Evidence of measurable disease.
• With adequate organ function and hematological parameters.
• Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.

Критерии исключения

• Other hematologic malignancies.
• Subjects with confirmed or suspected central nervous system infiltration or meningeal involvement.
• Uncontrolled infection.
• Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
• Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
• Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
• Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.

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

Китай · 1 центр

• Beijing Chaoyang Hospital affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT07297329 · SCTC21C-A301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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