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

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:

MedlinePlus related topics: Fever Multiple Myeloma

Drug Information available for: Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

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:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Layton JE, Hall NE. The interaction of G-CSF with its receptor. Front Biosci. 2006 Sep 1;11:3181-9. Review.

Martin-Christin F. Granulocyte colony stimulating factors: how different are they? How to make a decision? Anticancer Drugs. 2001 Mar;12(3):185-91. Review.

Ono M. Physicochemical and biochemical characteristics of glycosylated recombinant human granulocyte colony stimulating factor (lenograstim). Eur J Cancer. 1994;30A Suppl 3:S7-11. Review.

Carter CR, Whitmore KM, Thorpe R. The significance of carbohydrates on G-CSF: differential sensitivity of G-CSFs to human neutrophil elastase degradation. J Leukoc Biol. 2004 Mar;75(3):515-22. Epub 2003 Dec 4.

Oh-eda M, Hasegawa M, Hattori K, Kuboniwa H, Kojima T, Orita T, Tomonou K, Yamazaki T, Ochi N. O-linked sugar chain of human granulocyte colony-stimulating factor protects it against polymerization and denaturation allowing it to retain its biological activity. J Biol Chem. 1990 Jul 15;265(20):11432-5.

Watts MJ, Addison I, Long SG, Hartley S, Warrington S, Boyce M, Linch DC. Crossover study of the haematological effects and pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers. Br J Haematol. 1997 Aug;98(2):474-9.

Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des. 2004;10(11):1235-44. Review.

Mattii L, Azzarà A, Fazzi R, Carulli G, Chimenti M, Cecconi N, Galimberti S, Petrini M. Glycosylated or non-glycosylated G-CSF differently influence human granulocyte functions through RhoA. Leuk Res. 2005 Nov;29(11):1285-92.

Azzarà A, Carulli G, Rizzuti-Gullaci A, Capochiani E, Petrini M. Lenograstim and filgrastim effects on neutrophil motility in patients undergoing chemotherapy: evaluation by computer-assisted image analysis. Am J Hematol. 2001 Apr;66(4):306-7. No abstract available.

Ribeiro D, Veldwijk MR, Benner A, Laufs S, Wenz F, Ho AD, Fruehauf S. Differences in functional activity and antigen expression of granulocytes primed in vivo with filgrastim, lenograstim, or pegfilgrastim. Transfusion. 2007 Jun;47(6):969-80.

Bodey GP, Buckley M, Sathe YS, Freireich EJ. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966 Feb;64(2):328-40. No abstract available.

Clark OA, Lyman GH, Castro AA, Clark LG, Djulbegovic B. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomized controlled trials. J Clin Oncol. 2005 Jun 20;23(18):4198-214.

Trillet-Lenoir V, Green J, Manegold C, Von Pawel J, Gatzemeier U, Lebeau B, Depierre A, Johnson P, Decoster G, Tomita D, et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer. 1993;29A(3):319-24.

Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35.

Höglund M, Smedmyr B, Bengtsson M, Tötterman TH, Cour-Chabernaud V, Yver A, Simonsson B. Mobilization of CD34+ cells by glycosylated and nonglycosylated G-CSF in healthy volunteers--a comparative study. Eur J Haematol. 1997 Sep;59(3):177-83.

de Arriba F, Lozano ML, Ortuño F, Heras I, Moraleda JM, Vicente V. Prospective randomized study comparing the efficacy of bioequivalent doses of glycosylated and nonglycosylated rG-CSF for mobilizing peripheral blood progenitor cells. Br J Haematol. 1997 Feb;96(2):418-20.

Ings SJ, Balsa C, Leverett D, Mackinnon S, Linch DC, Watts MJ. Peripheral blood stem cell yield in 400 normal donors mobilised with granulocyte colony-stimulating factor (G-CSF): impact of age, sex, donor weight and type of G-CSF used. Br J Haematol. 2006 Sep;134(5):517-25.

Fischer JC, Frick M, Wassmuth R, Platz A, Punzel M, Wernet P. Superior mobilisation of haematopoietic progenitor cells with glycosylated G-CSF in male but not female unrelated stem cell donors. Br J Haematol. 2005 Sep;130(5):740-6.

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 May 16, 2013