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

Phase 3

• Conditions: G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
• Interventions: Drug: filgrastim; Drug: lenograstim

• Registration Number: NCT00932217
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-04
• Status Verified: 2009-02
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Last Update Submitted: 2009-07-02
• Study First Posted: 2009-07-03
• Last Update Posted: 2009-07-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
filgrastim	filgrastim	patients mobilized with filgrastim
lenograstim	lenograstim	patients mobilized with lenograstim

Primary Outcome Measures

Name	Time	Method
febrile episode	30 days

Secondary Outcome Measures

Name	Time	Method
Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety	30 days