Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
This trial is active, not recruiting.
|Condition||g-csf, multiple myeloma, febrile episode, filgrastim, leograstim|
|Sponsor||University of Pisa|
|Start date||December 2004|
|End date||April 2007|
|Trial size||180 participants|
|Trial identifier||NCT00932217, Pisa 01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
patients mobilized with filgrastim
patients mobilized with lenograstim
time frame: 30 days
Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety
time frame: 30 days
Male or female participants from 18 years up to 70 years old.
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
|Official title||Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma|
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