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

University of Pisa

Status and phase: Unknown; Phase 3

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

Treatments: Drug: filgrastim; Drug: lenograstim

Study type: Interventional

Funder types: Other

Identifiers

NCT00932217

Pisa 01

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

filgrastim

Active Comparator group

Description:

patients mobilized with filgrastim

Treatment:

Drug: filgrastim

lenograstim

Active Comparator group

Description:

patients mobilized with lenograstim

Treatment:

Drug: lenograstim