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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
filgrastim
lenograstim
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    filgrastim

    lenograstim

    Arm Description

    patients mobilized with filgrastim

    patients mobilized with lenograstim

    Outcomes

    Primary Outcome Measures

    febrile episode

    Secondary Outcome Measures

    Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety

    Full Information

    First Posted
    July 2, 2009
    Last Updated
    July 2, 2009
    Sponsor
    University of Pisa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00932217
    Brief Title
    Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
    Official Title
    Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Pisa

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    filgrastim
    Arm Type
    Active Comparator
    Arm Description
    patients mobilized with filgrastim
    Arm Title
    lenograstim
    Arm Type
    Active Comparator
    Arm Description
    patients mobilized with lenograstim
    Intervention Type
    Drug
    Intervention Name(s)
    filgrastim
    Intervention Description
    subcutaneous filgrastim administration
    Intervention Type
    Drug
    Intervention Name(s)
    lenograstim
    Intervention Description
    subcutaneous lenograstim administration
    Primary Outcome Measure Information:
    Title
    febrile episode
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 and < 70 years Diagnosis of multiple myeloma ECOG < 2 to be evaluated at baseline, after the induction chemotherapy Indication to the mobilization with high dose cyclophosphamide chemotherapy Normal blood counts: neutrophils > 1500/μl; platelets > 100.000/μl; hemoglobin > 10 g/dl. 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. Interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days ECG e/o Echocardiogram within age related normal range Negative HCV and HbsAg Must be willing and able to fill in the patient's diary Written informed consent Exclusion Criteria: Documented and/or suspected infections Uncontrolled concurrent illness Documented cardiac dysfunction

    12. IPD Sharing Statement

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

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