Multicenter, Open-label and Randomized Trial to Optimize Multiple Myeloma therapy: Single High-Dose Therapy with Melphalan 200mg/m² followed by Transplantation of Peripheral Hematopoietic Progenitor Cellsvs.Tandem High-Dose Therapy with Sequential Melphalan 200mg/m² followed by Transplantation of Peripheral Hematopoietic Progenitor Cells
- Conditions
- C90.00
- Registration Number
- DRKS00008864
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 385
Inclusion Criteria
• Patients with MM stage II or III according to the Salmon and Durie staging,
• Prior treatment with alkylator–based chemotherapy = 6 cycles,
• Age = 18 and = 66 years,
• Minimum life expectancy = 12 months
• No disease progression during prior conventional chemotherapy,
• WHO-Status = 2 (this criteria obtains to the high dose therapy study),
• Patients written informed consent to participate in the study
• Patients willingness to cooperate throughout the entire study
• No participation in another study
Exclusion Criteria
• Plasma Cell Leukemia, more than 2000 (immunological and/or conventional, cytological detection) plasma cells per 1 µl blood
• Clinical manifested heart failure (>NYHA II, New York Heart Association), echocardiography left ventricular ejection fraction < 65%,
• Liver Disease with increased transaminases and bilirubin exceeding the normal range more than three times
• Known HIV infection
• Women: pregnancy and nursing/lactation, lack of contraception
• Manifested depression
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To provide proof that a Single-High Dose Therapy with Melphalan 200 mg/m² followed by Transplantation of Peripheral Hematopoietic Progenitor Cells is not inferior to a Tandem-High Dose Therapy with sequential Melphalan 200 mg/m² followed by Transplantation of Peripheral Hematopoietic Progenitor Cells regarding two year event-free survival after High Dose Therapy followed by Transplantation.
- Secondary Outcome Measures
Name Time Method