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

NCT ID: NCT00932217

Last Updated: 2009-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

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.

Conditions

G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

filgrastim

patients mobilized with filgrastim

Group Type: ACTIVE_COMPARATOR

filgrastim

Intervention Type: DRUG

subcutaneous filgrastim administration

lenograstim

patients mobilized with lenograstim

Group Type: ACTIVE_COMPARATOR

lenograstim

Intervention Type: DRUG

subcutaneous lenograstim administration

Interventions

filgrastim

subcutaneous filgrastim administration

Intervention Type: DRUG

lenograstim

subcutaneous lenograstim administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

University of Pisa

References

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Other Identifiers

Pisa 01

Identifier Type: -

Identifier Source: org_study_id