Status:
UNKNOWN
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
Lead Sponsor:
University of Pisa
Conditions:
G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Age \> 18 and \< 70 years
- Diagnosis of multiple myeloma
- ECOG \< 2 to be evaluated at baseline, after the induction chemotherapy
- Indication to the mobilization with high dose cyclophosphamide chemotherapy
- Normal blood counts: neutrophils \> 1500/μl; platelets \> 100.000/μl; hemoglobin \> 10 g/dl.
- 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.
- Interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days
- ECG e/o Echocardiogram within age related normal range
- Negative HCV and HbsAg
- Must be willing and able to fill in the patient's diary
- Written informed consent
Exclusion
- Documented and/or suspected infections
- Uncontrolled concurrent illness
- Documented cardiac dysfunction
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00932217
Start Date
December 1 2004
Last Update
July 3 2009
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