A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned

Официальное название

A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Обзор

The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \[WBCs\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.

Вмешательства

• Препарат Ramantamig
  Ramantamig will be administered subcutaneously.
• Препарат Daratumumab
  Daratumumab will be administered subcutaneously.
• Препарат Lenalidomide
  Lenalidomide will be administered orally.
• Препарат Bortezomib
  Bortezomib will be administered subcutaneously or intravenously.
• Препарат Dexamethasone
  Dexamethasone will be administered orally or intravenously.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 62 months]
• Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response CR [Срок оценки: Up to 12 months]

Вторичные конечные точки (12)

• Overall Survival (OS) [Срок оценки: Up to approximately 100 months]
• Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR [Срок оценки: Up to 5 years]
• Percentage of Participants with Very Good Partial Response (VGPR) or Better [Срок оценки: Up to 5 years]
• Percentage of Participants with CR or Better [Срок оценки: Up to 5 years]
• Percentage of Participants with Overall Response [Срок оценки: Up to 5 years]
• Percentage of Participants with Overall MRD-Negative CR [Срок оценки: Up to 5 years]
• Percentage of Participants with 12-Month Sustained MRD-Negative CR [Срок оценки: Up to 5 years]
• Progression Free Survival After Subsequent Therapy (PFS2) [Срок оценки: Up to approximately 100 months]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 100 months]
• Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score [Срок оценки: Baseline up to approximately 100 months]
• Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score [Срок оценки: Baseline up to approximately 100 months]
• Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score [Срок оценки: Baseline up to approximately 100 months]

Критерии участия

Критерии включения

• Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria
• Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or iii. deferral of high-dose chemotherapy with ASCT as initial treatment
• Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2
• Must sign an informed consent form (ICF)
• Measurable disease at screening as assessed by central laboratory as defined in the protocol

Критерии исключения

• Myeloma Frailty Score of greater than or equal to (>=) 2 with the exception of participants who have a score of 2 based on age alone
• Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients
• Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial
• Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM
• Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07665450 · 79635322MMY3004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗