Clinical trial NCT00932217: Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
Official title: Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: febrile episode
timeFrame: 30 days
Secondary outcomes:
measure: Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
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