Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma

Universitätsklinikum Hamburg-Eppendorf

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

Study type

Interventional

Funder types

Other

Identifiers

NCT00777998

Auto-Allo TSCT in MM

Details and patient eligibility

About

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 and age of >_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.

Enrollment

221 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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 > 61 years