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 sites220 target enrollmentMarch 28, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 28, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center Hamburg-Eppendorf

•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

•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).