Status:
COMPLETED
Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma...
Eligibility Criteria
Inclusion
- Multiple Myeloma Stage II or III acc. to Salmon and Durie
- Patient's age 18-60 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
- 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 \> 61 years
Key Trial Info
Start Date :
October 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00777998
Start Date
October 14 2008
End Date
June 1 2021
Last Update
October 27 2023
Active Locations (20)
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1
Klinikum Augsburg
Augsburg, Germany, 86156
2
Charité
Berlin, Germany, 12203
3
Universitätsklinikum Dresden
Dresden, Germany, 01307
4
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225