EUCTR2021-001005-67-DE进行中（未招募）1 期
Allogeneic stem cell transplantation vs. conventional therapy as salvage therapy for relapsed / progressed patients with multiple myeloma after first-line therapy (AlloRelapseMMStudy)
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 482 人开始时间: 2021年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 482
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients eligible for study inclusion must meet criteria 1-6 at registration and all of the following criteria before randomization:
- •1)Multiple Myeloma
- •2)Age 18 - 65 years
- •3)A signed informed consent form must be obtained before participation in the study
- •4)Age 66 - 70 years, if comorbidity index according to Sorror score = 0 and ECOG = 1
- •5)1. Relapsed/progressed after autologous SCT (single or tandem)
- •First line therapy comprises induction therapy followed by single or tandem autologous transplantation and maintenance therapy
- •6)Negative pregnancy test in female patients
- •7)Maximum of 1 cycle salvage therapy prior to study inclusion
- •8)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
- •9)CR/PR or SD according to IMWG-criteria after 3 cycles salvage therapy within the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 434
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •Patients are excluded from the study if any one of criteria 1-4 are met at registration and if criterion 5 is met before randomization:
- •1)Non-sufficient organ function defined as:
- •Bilirubin (in the absence of Meulengracht's disease), SGPT or SGOT =3 higher than normal values
- •Cardiac ejection fraction = 50%
- •GFR < 30 ml/min
- •DLCO < 50% and/or continuous oxygen dependency
- •2)Active hepatitis B or C or uncontrolled HIV infection
- •3)Other, active malignant disease
- •4)Prior treatment with allogeneic stem cells
- •5)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 registration
- •6)Positive serum pregnancy test at screening and before first treatment or breastfeeding
- •7)PD under salvage therapy
研究者
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