2024-510590-14-00已完成3 期
Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressive patients with multiple myeloma after a first-line therapy
University Medical Center Hamburg-Eppendorf30 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年9月2日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 30
- 主要终点
- Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)
研究概览
简要总结
The present clinical study aims to demonstrate the superiority of allogeneic stem (alloSCT) cell transplantation compared to conventional therapy for the difference in overall survival (OS) at 5 years in patients with multiple myeloma who have relapsed or progressed after first-line autologous hematopoietic stem cell therapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for study inclusion/enrollment must meet criteria 1-7 and all of the criteria (1-9) before randomization
- •CR/ PR or SD according to IMWG criteria after 3 cycles salvage therapy within the study
- •Multiple Myeloma
- •Age 18 - 65 years
- •A signed informed consent form must be obtained before participation in the study
- •Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG ≤ 1
- •1st relapse/ progression according to IMWG criteria after first-line therapy (consisting of induction therapy followed by autologous transplantation once or twice and maintenance therapy) Additionally: meeting the need for treatment based on the SLiM-CRAB-criteria
- •Negative pregnancy test in female patients
- •Maximum of 1 cycle salvage therapy prior to study inclusion/enrollment
- •Availability of a fully compatible stem cell donor (HLA-ident. sibling or 10/10 MUD or 9/10 MMUD if mismatch affects DQB) after 3 cycles salvage therapy
排除标准
- •Patients are not included in the study if any one of criteria 1-6 are met and if criterion 7 is met before randomization:
- •Non-sufficient organ function defined as: Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT ≥ 3 times higher than normal values Cardiac ejection fraction ≤ 50 % GFR < 30 ml/min DLCO < 35 % or continuous oxygen dependency
- •Active hepatitis B or C infection or uncontrolled HIV infection
- •Other, active malignant disease
- •Prior treatment with allogeneic stem cells
- •Participation in a clinical trial or taking an IMP within 30 days or five times the half-life of the IMP, whichever is longer, prior to study inclusion/enrollment
- •Positive serum pregnancy test at screening and before first treatment or breastfeeding
- •Progressive disease (PD) on salvage therapy
结局指标
主要结局
Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)
Overall survival (OS) at five years after randomization (Patient observed from randomization until database lock for final analysis and overall survival rate calculated at 5 years after randomization)
次要结局
- Event-free survival (EFS) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 1 year after randomization). Event defined as: Progression (according to IMWG criteria) or Relapse (according to IMWG criteria) or Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or Death of any cause
- Event-free survival at 3 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 3 years after randomization) Event defined as: Progression (according to IMWG criteria) or Relapse (according to IMWG criteria) or Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or Death of any cause
- Event-free survival at 5 years after randomization (Patient observed from randomization until database lock for final analysis and EFS rate calculated at 5 years after randomization) Event defined as: Progression (according to IMWG criteria) or Relapse (according to IMWG criteria) or Engraftment Failure (defined as no stable neutrophil count > 0.5 x 109/l on day 28 after SCT, see 11.2.12) or Death of any cause
- Change from baseline in total EORTC score at 1 year after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 1 year after randomization)
- Change from baseline in total EORTC score at 3 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 3 years after randomization)
- Change from baseline in total EORTC score at 5 years after randomization (Patient observed from baseline until database lock for final analysis and adjusted mean calculated at 5 years after randomization)
- Time to first occurrence of remission (partial or complete) after randomization (Patient is followed from randomization until database lock for final analysis and cumulative incidence of first remission, at 2 years after randomization, is reported)
- Non-relapse mortality (NRM) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 1 year after randomization reported)
- Non-relapse mortality (NRM) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 3 years after randomization reported)
- Non-relapse mortality (NRM) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of death before any relapse at 5 years after randomization reported)
- Cumulative incidence of acute graft-versus-host disease (GvHD) after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 1year after randomization reported)
- Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al.[1]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 3 years after randomization reported
- Cumulative incidence of acute GvHD after allogeneic stem cell transplantation (according to Przepiorka et al. [1]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any acute GvHD at 5 years after randomization reported)
- Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al.[2]) at 1 year after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 1 year after randomization reported)
- Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 3 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 3 years after randomization reported)
- Cumulative incidence of chronic GvHD after allogeneic stem cell transplantation (according to Jagasia et al. [2]) at 5 years after randomization (Patient observed from randomization until database lock for final analysis and cumulative incidence of any chronic GvHD at 5 years after randomization reported)
- Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 1 year after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 1 year after randomization reported).
- Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 3 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 3 years after randomization reported).
- Time to first occurrence of infection reported as cumulative incidence of infection with CTCAE grade 3 - 5 at 5 years after randomization (patient observed from randomization until database lock for final analysis and cumulative incidence of any infectious complication with CTCAE grade 3 - 5 at 5 years after randomization reported).
研究者
Sponsor UKE Hamburg
Scientific
University Medical Center Hamburg-Eppendorf
研究点 (30)
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