Идёт набор NCT05372354
A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CC-92480, Tazemetostat, BMS-986158, Trametinib.
- Кому может быть актуально
- Состояния в реестре: Multiple Myeloma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Канада, Норвегия, Испания, Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma
Обзор
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
Вмешательства
- Препарат CC-92480
Specified dose on specified days - Препарат Tazemetostat
Specified dose on specified days - Препарат BMS-986158
Specified dose on specified days - Препарат Trametinib
Specified dose on specified days - Препарат Dexamethasone
Specified dose on specified days
Первичные конечные точки
- Number of participants with adverse events (AEs) [Срок оценки: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years]
- Number of participants with Serious AEs [Срок оценки: Up to approximately 4 years]
- Number of participants with AEs meeting protocol-defined DLT criteria [Срок оценки: Up to approximately 4 years]
- Number of participants with AEs leading to discontinuation [Срок оценки: Up to approximately 4 years]
- Number of deaths [Срок оценки: Up to approximately 4 years]
- Establish recommended Phase 2 dose (RP2D) [Срок оценки: Up to approximately 2 years]
- Establish dosing schedule of each combination for Part 2 Dose Expansion [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (12)
- Overall response rate (ORR) [Срок оценки: Up to approximately 4 years]
- Very good partial response rate (VGPRR) [Срок оценки: Up to approximately 4 years]
- Complete response rate (CRR) [Срок оценки: Up to approximately 4 years]
- Time-to-response (TTR) [Срок оценки: Up to approximately 4 years]
- Duration of response (DOR) [Срок оценки: Up to approximately 4 years]
- Progression-free survival (PFS) [Срок оценки: Up to approximately 4 years]
- Maximum observed plasma concentration (Cmax) [Срок оценки: Up to approximately 28 days]
- Time to maximum plasma concentration (Tmax) [Срок оценки: Up to approximately 28 days]
- Area under the concentration-time curve (AUC) [Срок оценки: Up to approximately 28 days]
- Terminal Half-Life (T-Half) [Срок оценки: Up to approximately 28 days]
- Apparent total body clearance (CLT/F) [Срок оценки: Up to approximately 28 days]
- Apparent volume of distribution (Vz/F) [Срок оценки: Up to approximately 28 days]
Критерии участия
Критерии включения
- Relapsed or refractory multiple myeloma (MM) and must:
- Have documented disease progression during or after their last myeloma therapy.
- For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
- Must have measurable disease.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).
Критерии исключения
- Known active or history of central nervous system (CNS) involvement of MM
- Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
- Impaired cardiac function or clinically significant cardiac disease
- Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
- For Part 1: received prior therapy with CC-92480
- For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
- Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
- Received any of the following within 14 days prior to initiating study treatment:
- Plasmapheresis
- Major surgery
- Radiation therapy other than local therapy for myeloma associated bone lesions
- Use of any systemic anti-myeloma drug therapy
- Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
- COVID-19 vaccine within 14 days prior to C1D1
Other protocol-defined inclusion/exclusion criteria apply
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 · 5 центров
- UAB Comprehensive Cancer Center — Birmingham
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center — Baltimore
- Dana-Farber Cancer Institute — Boston
- John Theurer Cancer Center at Hackensack UMC — Hackensack
- Memorial Sloan Kettering Cancer Center — New York
Великобритания · 5 центров
- The Christie NHS Foundation Trust — Manchester
- Local Institution - 0001 — Leicester
- Local Institution - 0014 — Liverpool
- Churchill Hospital — Oxford
- NIHR UCLH Clinical Research Facility — London
Канада · 3 центра
- Alberta Health Services AHS - Foothills Medical Centre FMC — Calgary
- University of Alberta - Cross Cancer Institute — Edmonton
- University Health Network UHN - Princess Margaret Hospital PMH — Toronto
Испания · 3 центра
- ICO - Hospital Germans Trias i Pujol — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Marques de Valdecilla — Santander
Норвегия · 1 центр
- Oslo University Hospital — Oslo
Идентификаторы
NCT: NCT05372354 · CA057-003 · 2023-509384-25 · U1111-1269-5704