G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim Clinical Trial
Official title:
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
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.
| Status | Active, not recruiting |
| Enrollment | 180 |
| Est. completion date | |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Pisa |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Layton JE, Hall NE. The interaction of G-CSF with its receptor. Front Biosci. 2006 Sep 1;11:3181-9. Review. — View Citation
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. — View Citation
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. — View Citation
Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des. 2004;10(11):1235-44. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | febrile episode | 30 days | Yes | |
| Secondary | Documented infectious episodes Collection efficiency (CD34+ cells/kilo) Mobilization days Safety | 30 days | Yes |