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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Pisa.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pisa
ClinicalTrials.gov Identifier:
NCT00932217
First received: July 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim
Drug: filgrastim
Drug: lenograstim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pisa:

Primary Outcome Measures:
  • febrile episode [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: December 2004
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: filgrastim
patients mobilized with filgrastim
Drug: filgrastim
subcutaneous filgrastim administration
Active Comparator: lenograstim
patients mobilized with lenograstim
Drug: lenograstim
subcutaneous lenograstim administration

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Mario Petrini, University of Pisa
ClinicalTrials.gov Identifier: NCT00932217     History of Changes
Other Study ID Numbers: Pisa 01
Study First Received: July 2, 2009
Last Updated: July 2, 2009
Health Authority: Italy: Institutional Review Board Ospedale S. Chiara, Pisa, Italy

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

ClinicalTrials.gov processed this record on August 26, 2014