Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy with Thalidomide / DLI for patients with Multiple Myeloma (MM) and age <= 60 years: A phase II-study - Auto-Allo-TSCT in MM with Thalidomide

niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 220 人开始时间: 2008年3月28日最近更新: 2020年4月20日

试验速览

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•Multiple Myeloma Stage II or III according to Salmon and Durie (see Protocol Appendix ?30.5 on page 75)
•Patient's age: 18 – 60 years.
•Patient's written informed consent.
•Compliance with Thalidomide Pregnancy Prevention Plan for Subjects in Clinical Trials” (see Protocol Appendix 30.14 on page 118); becoming effective with protocol version August 27, 2015.
•A maximum of eight chemotherapy cycles prior to registration (CR / PR / MR / or PD).(Melphalan containing regimen should be avoided as induction therapy)
•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 220
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•More than eight chemotherapy cycles prior to registration.
•Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
•Total bilirubin, SGPT or SGOT > 3 times upper the normal level.
•Left ventricular ejection fraction < 30 %.
•Creatinine clearance < 30 ml/min.
•DLCO < 35 % and/or receiving supplementary continuous oxygen.
•Positive serology for HIV.
•Pregnant or lactating women.
•Participation in another trial at time of registration.
•No HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one mismatch allowed).
•Preceding autologous stem cell transplantation.
•Age > 61 years.

发起方

niversity Medical Center Hamburg-Eppendorf