Overview

This trial is active, not recruiting.

Condition g-csf, multiple myeloma, febrile episode, filgrastim, leograstim
Treatments filgrastim, lenograstim
Phase phase 3
Sponsor University of Pisa
Start date December 2004
End date April 2007
Trial size 180 participants
Trial identifier NCT00932217, Pisa 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
patients mobilized with filgrastim
filgrastim
subcutaneous filgrastim administration
(Active Comparator)
patients mobilized with lenograstim
lenograstim
subcutaneous lenograstim administration

Primary Outcomes

Measure
febrile episode
time frame: 30 days

Secondary Outcomes

Measure
Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety
time frame: 30 days

Eligibility Criteria

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

Additional Information

Official title Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by University of Pisa.