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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00932217
Recruitment Status : Unknown
Verified February 2009 by University of Pisa.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2009
Last Update Posted : July 3, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim Drug: filgrastim Drug: lenograstim Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
Study Start Date : December 2004
Actual Primary Completion Date : April 2007

Arm Intervention/treatment
Active Comparator: filgrastim
patients mobilized with filgrastim
Drug: filgrastim
subcutaneous filgrastim administration
Active Comparator: lenograstim
patients mobilized with lenograstim
Drug: lenograstim
subcutaneous lenograstim administration

Primary Outcome Measures :
  1. febrile episode [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


Responsible Party: Mario Petrini, University of Pisa Identifier: NCT00932217     History of Changes
Other Study ID Numbers: Pisa 01
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Body Temperature Changes
Signs and Symptoms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs