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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pisa
• Treatments: Lenograstim

Criteria

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