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

NCT00932217 | Unknown Phase 3 DMC

• 1 other identifier: Pisa 01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• febrile episode

  30 days

Secondary Outcomes (1)

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

  30 days

Study Arms (2)

filgrastim

ACTIVE COMPARATOR

patients mobilized with filgrastim

Drug: filgrastim

lenograstim

ACTIVE COMPARATOR

patients mobilized with lenograstim

Drug: lenograstim

Interventions

filgrastim DRUG

subcutaneous filgrastim administration

filgrastim

lenograstim DRUG

subcutaneous lenograstim administration

lenograstim

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Documented and/or suspected infections
• Uncontrolled concurrent illness
• Documented cardiac dysfunction

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (18)

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• Martin-Christin F. Granulocyte colony stimulating factors: how different are they? How to make a decision? Anticancer Drugs. 2001 Mar;12(3):185-91. doi: 10.1097/00001813-200103000-00002.

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

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• 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. doi: 10.1189/jlb.0803378. Epub 2003 Dec 4.

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• 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.

  PMID: 1694845 BACKGROUND

• 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. doi: 10.1046/j.1365-2141.1997.2393053.x.

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• Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des. 2004;10(11):1235-44. doi: 10.2174/1381612043452613.

  PMID: 15078138 BACKGROUND

• Mattii L, Azzara 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. doi: 10.1016/j.leukres.2005.04.011.

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• Azzara 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. doi: 10.1002/ajh.1064. No abstract available.

  PMID: 11279646 BACKGROUND

• 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. doi: 10.1111/j.1537-2995.2007.01241.x.

  PMID: 17524085 BACKGROUND

• 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. doi: 10.7326/0003-4819-64-2-328. No abstract available.

  PMID: 5216294 BACKGROUND

• 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. doi: 10.1200/JCO.2005.05.645.

  PMID: 15961767 BACKGROUND

• 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. doi: 10.1016/0959-8049(93)90376-q.

  PMID: 7691119 BACKGROUND

• 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. doi: 10.1093/annonc/mdg019.

  PMID: 12488289 BACKGROUND

• Hoglund M, Smedmyr B, Bengtsson M, Totterman 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. doi: 10.1111/j.1600-0609.1997.tb00972.x.

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• de Arriba F, Lozano ML, Ortuno 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. doi: 10.1046/j.1365-2141.1997.d01-2029.x.

  PMID: 9029036 BACKGROUND

• 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. doi: 10.1111/j.1365-2141.2006.06223.x.

  PMID: 17018030 BACKGROUND

• 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. doi: 10.1111/j.1365-2141.2005.05678.x.

  PMID: 16115131 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Filgrastim; Lenograstim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: December 1, 2004
• Primary Completion: April 1, 2007
• Last Updated: July 3, 2009

Record last verified: 2009-02