A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

Официальное название

A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

Обзор

The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).

Вмешательства

• Препарат Elranatamab
  Specified dose on specified days
• Препарат Mezigdomide
  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 mezigdomide dose or 90 days after last elranatamab dose, whichever is longer]
• Number of participants with Serious AEs [Срок оценки: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer]
• Number of participants with AEs meeting protocol-defined DLT criteria [Срок оценки: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer]
• Number of participants with AEs leading to discontinuation [Срок оценки: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer]
• Number of deaths [Срок оценки: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer]
• Recommended Phase 2 Dose (RP2D) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]

Вторичные конечные точки (8)

• International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Complete Response Rate (CRR) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Time to Response (TTR) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Duration of Response (DOR) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Progression-free Survival (PFS) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• IMWG Uniform Response Criteria: Overall Survival (OS) [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]
• Number of participants who achieve minimal residual disease (MRD) negativity [Срок оценки: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)]

Критерии участия

Критерии включения

• Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).
• Measurable MM by local laboratory.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
• Adherence to contraception requirements.

Критерии исключения

• Prior treatment with mezigdomide.
• Prior treatment with T cell engaging or T cell engager (TCE).
• Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy
• 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

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• University of Alabama at Birmingham — Birmingham
• Yale New Haven Hospital-Smilow Cancer Center — New Haven
• Hackensack University Medical Center — Hackensack
• University of Texas MD Anderson Cancer Center — Houston

Канада · 4 центра

• Arthur J E Child Comprehensive Cancer Centre — Calgary
• Local Institution - 0026 — Vancouver
• QEII Health Sciences Centre - Victoria General Site — Halifax
• Princess Margaret Cancer Centre — Toronto

Германия · 3 центра

• Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg
• Universitaetsklinikum Heidelberg — Heidelberg

Великобритания · 3 центра

• University College London Hospital — London
• Royal Marsden Hospital (Sutton) — London
• The Christie NHS Foundation Trust — Manchester

Китай · 2 центра

• Local Institution - 0030 — Сучжоу
• Local Institution - 0031 — Шанхай

Греция · 2 центра

• Evangelismos General Hospital of Athens — Athens
• Alexandra General Hospital of Athens — Athens

Норвегия · 2 центра

• St. Olavs Hospital — Trondheim
• Sykehusapoteket Ull — Oslo

Испания · 2 центра

• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca

Идентификаторы

NCT: NCT06988488 · CA057-1040 · 2025-522090-11 · U1111-1317-4901

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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