Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma

Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma

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.

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