Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < 55 Years: A Phase II-study
18 Years
55 Years
Both
Multiple Myeloma
Trial Information
Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < 55 Years: A Phase II-study
Inclusion Criteria:
- Multiple Myeloma Stage II or III acc. to Salmon and Durie
- Patient's age 18-55 years
- Patient's written informed consent
- Women and men capable of reproduction must agree to use adequate contraceptive
measures (condom, IUD, oral contraceptives) until three months after termination of
treatment
- a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
Exclusion Criteria:
- 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 the time of registration
- Preceding autologous stem cell transplantation
- age > 56 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.
Outcome Time Frame:
four years after Tandem stem cell transplantation
Safety Issue:
Yes
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Auto-Allo TSCT in MM
NCT ID:
NCT00777998
Start Date:
August 2008
Completion Date:
May 2017
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Stem Cell Transplantation
- Thalidomide
- DLI
- Multiple Myeloma
- Neoplasms, Plasma Cell
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