A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Официальное название

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Обзор

This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).

Вмешательства

• Препарат Cemsidomide
  dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle
• Препарат Dexamethasone
  dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Первичные конечные точки

• Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) [Срок оценки: up to approximately 43 months]

Вторичные конечные точки (7)

• Duration of response (DoR; IRC assessed) [Срок оценки: up to approximately 43 months]
• Complete response (CR) rate (IRC assessed) [Срок оценки: up to approximately 43 months]
• Time to response (IRC assessed) [Срок оценки: up to approximately 43 months]
• Progression free survival (PFS; IRC assessed) [Срок оценки: up to approximately 43 months]
• Overall survival (OS) [Срок оценки: up to approximately 43 months]
• Adverse events (AEs); serious AEs (SAEs); AEs leading to treatment interruption, reduction, or discontinuation; and deaths [Срок оценки: within 30 to 35 days of the last dose of study treatment]
• Plasma concentrations of cemsidomide [Срок оценки: up to approximately 4 months]

Критерии участия

Критерии включения

• Be willing and able to provide signed informed consent for the study.
• Age ≥ 18 years at the time of signed consent.
• Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
• Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.
• Subjects need to have adequate organ function.
• Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1.
• Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.
• Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
• Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
• Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.

Критерии исключения

• Presence of myeloma in the central nervous system (CNS).
• Subjects with any of the following:

• Systemic light chain amyloidosis
• Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
• Myelodysplastic syndrome (MDS).
• Previously treated with cemsidomide.
• Clinically significant impaired cardiac function or cardiac disease.
• Thromboembolic event within 3 months prior to enrollment.
• Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
• Uncontrolled active bacterial, fungal, or viral infection.
• Inability or difficulty swallowing tablets.

NOTE: Other inclusion/exclusion criteria may apply, per protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Clearview Cancer Institute — Huntsville
• Mayo Clinic - Arizona — Phoenix
• HonorHealth — Scottsdale
• Berenson Cancer Center — West Hollywood
• Mayo Clinic - Florida — Jacksonville
• Winship Cancer Institute, Emory University — Atlanta
• Indiana University Health — Indianapolis
• University of Iowa — Iowa City
• … и ещё 12 центров

Великобритания · 1 центр

• Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital — London

Идентификаторы

NCT: NCT07284758 · CFT7455-2101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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