Clinical trial · Interventional
Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma
NCT00932217CI-TRIAL-00002428unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Drug | Filgrastim | ALIAS |
| lenograstim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- filgrastim
- description
- patients mobilized with filgrastim
- interventionNames
- Drug: filgrastim
- type
- ACTIVE_COMPARATOR
- label
- lenograstim
- description
- patients mobilized with lenograstim
- interventionNames
- Drug: lenograstim
Primary outcomes (1)
- measure
- febrile episode
- timeFrame
- 30 days
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDLayton JE, Hall NE. The interaction of G-CSF with its receptor. Front Biosci. 2006 Sep 1;11:3181-9. doi: 10.2741/2041. PMID 16720384
- BACKGROUNDMartin-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. PMID 11290864
- BACKGROUNDOno M. Physicochemical and biochemical characteristics of glycosylated recombinant human granulocyte colony stimulating factor (lenograstim). Eur J Cancer. 1994;30A Suppl 3:S7-11. PMID 7535073
- BACKGROUNDCarter 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. PMID 14657210
- BACKGROUNDOh-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
- BACKGROUNDWatts 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. PMID 9266953
- BACKGROUNDMolineux 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
- BACKGROUNDMattii 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.