C90.00
Conditions
Interventions
Group 1: Arm A - High-dose melphalan (alkeran) 200mg/m2 (on day -2) followed by autologous blood stem cell transplantation (on day 0). (=single high-dose therapy)
Group 2: Arm B - High-dose melphalan
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • The toxicities of the Single and Tandem High Dose Therapy with Melphalan 200mg/m² followed by Transplantation of Peripheral Hematopoietic Progenitor Cells shall be compared. (period: during high-dose therapy/inpatient stay until 100 days thereafter) • The overall survival time after single-high dose therapy shall be compared with the time after tandem high dose therapy. (period: until recent follow-up, no specific timepoint stated) • To compare the efficiency of tumor mass reduction, the toxicity and the rate of infectious complications of VAD and VID induction therapies. (time: after induction therapy) • The possibility of a repeated PBPC-Collection after the first transplantation cycle with 200 mg/m² Melphalan shall be evaluated in 20 patients at two centers. The contamination of the tumor cells shall be analyzed by quantitative PCR. A comparison of the tumor cell contamination in the transplants after HD-CY and HD-Melphalan shall be effected. (time: before/after first high-dose therapy) • The influence of Interferon-a maintenance therapy on the response status and the toxicity of this treatment according to both varying high dose therapies shall be evaluated. (period: after first or second high-dose therapy) • Molecular biological examinations shall take place to show residual myeloma cells with quantitative tumor specific PCR (ASO-PCR) upon treatment start, within leucapheresis products before and after a CD34?? stem cell selection and later in 40 patients who achieved a CR. The „minimal residual disease“ in transplants and after high dose therapy shall be analyzed regarding its prognostic relevance. (period: during the whole study, specifically upon initial diagnosis, before and after first/second high-dose therapy and during maintenance therapy) • In addition, immune-cytological examinations shall take place to detect cells of the myeloma clones in patients, in leucapheresis products and in the follow-up to analyze the prognostic value of circulating myelo | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactHartmut Goldschmidt
Medizinische Klinik V, Universitätsklinikum Heidelberg
Outcome results
None listed