G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
Conditions
Brief summary
To evaluate the difference in the incidence of febrile episodes in patients undergoing stem cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim. A febrile episode will be considered as: body temperature \> 38°C for two measurements in the 24 hours with an interval of 6 hours at least between the two measurements.
Interventions
DRUGfilgrastim
subcutaneous filgrastim administration
DRUGlenograstim
subcutaneous lenograstim administration
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 and \< 70 years 2. Diagnosis of multiple myeloma 3. ECOG \< 2 to be evaluated at baseline, after the induction chemotherapy 4. Indication to the mobilization with high dose cyclophosphamide chemotherapy 5. Normal blood counts: neutrophils \> 1500/μl; platelets \> 100.000/μl; hemoglobin \> 10 g/dl. 6. Liver and renal function: SGOT/AST, SGPT/ALT; bilirubin \< 1.5 times the upper limit of the normal ranges; creatinine \< 2 times the upper limit of the normal ranges. 7. Interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days 8. ECG e/o Echocardiogram within age related normal range 9. Negative HCV and HbsAg 10. Must be willing and able to fill in the patient's diary 11. Written informed consent
Exclusion criteria
1. Documented and/or suspected infections 2. Uncontrolled concurrent illness 3. Documented cardiac dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| febrile episode | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety | 30 days |
Outcome results
None listed