Risk Stratification and MRD-driven Maintenance for MM After ASCT

Официальное название

Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation

Обзор

This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.

Вмешательства

• Препарат Daratumumab
  Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
• Препарат Lenalidomide
  Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance.

Первичные конечные точки

• MRD (Minimal Residual Disease) status at 12 months after maintenance [Срок оценки: 12 months]

Вторичные конечные точки (4)

• CR+VGPR [Срок оценки: 12 months]
• Estimated 3 year-PFS [Срок оценки: 3 years]
• Estimated 3 year OS [Срок оценки: 3 years]
• TRAEs [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
• Must have a partial response (PR) or better response before maintenance.
• Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
• This study allows for post-ASCT consolidation therapy.
• ANC ≥ 1.0 x 10\^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10\^9/L (if BMPC < 50%) or PLT ≥ 50 x 10\^9/L (if BMPC ≥ 50%).
• No active infection.
• a).TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 45mL/min.

Критерии исключения

• Must not refractory or non-tolerate to lenalidomide in Arm A.
• Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
• Must not have progressed on multiple myeloma (MM) therapy before screening
• Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
• Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
• History of stroke or serious thrombotic event within 12 months prior to screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Fuxing Hospital — Пекин
• Peking Union Medical College Hospital — Пекин
• Peking University People's Hospital — Пекин
• The First Affiliated Hospital of Harbin Medical University — Харбин

Идентификаторы

NCT: NCT06697483 · 2024PHB165-001-20240930

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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