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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

febrile episode

Outcome Time Frame:

30 days

Safety Issue:

Yes

Authority:

Italy: Institutional Review Board Ospedale S. Chiara, Pisa, Italy

Study ID:

Pisa 01

NCT ID:

NCT00932217

Start Date:

December 2004

Completion Date:

Related Keywords:

  • G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
  • Fever
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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