Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma

Официальное название

A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

Обзор

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

Вмешательства

• Препарат Etentamig
  Administered per the protocol
• Препарат Isatuximab
  Administered per the protocol
• Препарат Bortezomib + Lenalidomide + Dexamethasone
  Administered per the protocol

Первичные конечные точки

• Safety and tolerability (Phase I) [Срок оценки: through induction treatment, on average 4 months]
• MRD negativity (Phase II) [Срок оценки: through consolidation phase completion, an average of 1 year]
• PFS [Срок оценки: up to 10 years]

Вторичные конечные точки (11)

• ORR [Срок оценки: up to 10 years]
• CR rate [Срок оценки: up to 10 years]
• VGPR Rate [Срок оценки: up to 10 years]
• DoR [Срок оценки: up to 10 years]
• TTR [Срок оценки: up to 10 years]
• PFS2 [Срок оценки: up to 10 years]
• OS [Срок оценки: up to 10 years]
• MRD negativity [Срок оценки: up to 10 years]
• Sustained MRD [Срок оценки: up to 10 years]
• MRD-negative CR [Срок оценки: up to 10 years]
• Sustained MRD-negative CR [Срок оценки: up to 10 years]

Критерии участия

Критерии включения

• Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
• Participants must have High-risk myeloma according to IMS/IMWG CGS
• Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
• Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
• Participants must have clinical laboratory values within a prespecified range.

Критерии исключения

• Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
• known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
• Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
• known central nervous system involvement by MM.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Medical Center Hamburg-Eppendorf — Hamburg

Идентификаторы

NCT: NCT07600151 · CONQUISTADOR trial · 2025-523049-83-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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