Predictive Value of the "Cytocapacity Test" Following a Single-dose of rHu-G-CSF in Patients With Lymphoproliferative Diseases and High-dose Therapy
Inclusion Criteria:
- Presence of histologically proven lymphoproliferative disease specified as Hodgkin's
disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma
- Indication of high-dose therapy and autologous peripheral blood stem cell
transplantation
- Availability of a sufficient amount of blood stem cells (CD34+ cells >= 2.0 x 106/kg)
- Age between 18 and 70 years
- High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or
200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see
Section 9.8.1)
- Patient's written consent to participation in this trial
Exclusion Criteria:
- Previous high-dose therapy and blood stem cell transplantation except for melphalan
140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in
the cytocapacity test previously (according to amendment 2, see Section 9.8.1).
- Known intolerance to lenograstim
- Out-patient therapy following high-dose therapy and blood stem cell transplantation
- Myocardial infarction < 6 months prior to inclusion into the study
- Cardiac arrhythmias Lown IV b
- Clinically manifest cardiac insufficiency (> NYHA II)
- Renal insufficiency with serum creatinine > 2 mg%
- Hepatic diseases with elevated levels of transaminases and bilirubin greater than
3-fold above normal
- Severe infections (HIV, Hepatitis B/C)
- Severe psychiatric diseases
- Non-curative treatment of other malignoma within the past 5 years
- Pregnant women or women breast-feeding