Patients suffering from a hematological malignancy (leukemia, lymphoma or multiple myeloma), after autologous blood stem cell transplantation MedDRA version: 9.1 Level: LLT Classification code 10024329 Term: Leukemia MedDRA version: 9.1 Level: LLT Classification code 10025310 Term: Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Neulasta 6mg Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegfilgrastim
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
GMIHO Gesellschaft für Medizinische Innovation/Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients with leukemia (with exceptions, cf. exclusion criteria), lymphoma or multiple myeloma (first-line or in first relapse) after autologous peripheral blood stem cell transplantation - transfused CD34+ >= 2,0*10^6/kg body weight - age >= 18 years - adequate contraceptive measures in case of reproductive potential (oral contraceptives, implantable or injectable contraceptive drugs, hormonal IUDs, vasectomy of the partner, or abstinence - negative pregnancy test - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - hypersensitivity against pegfilgrastim, other proteins manufactured using E. coli, or one of the drugs other components - patients with myelodysplastic syndrome - patients with chronic myeloid leukemia - patients with secondary AML - pregnant or lactating women - insufficient compliance anticipated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of pegfilgrastim administered on day 1 vs. day 4 after transplantation on the time to granulocyte engraftment > 500/ml;Secondary Objective: To compare: - median times to granulocyte engraftment > 1000/µl, to platelet engraftment >20000/µl and >50000/µl - rate and duration of febrile episodes - rate and duration of iv antibiotic treatment - number of blood transfusions - duration of days in hospital - adverse effecst of pegfilgrastim - pharmacokinetics of pegfilgrastim ;Primary end point(s): time to granulocyte recovery as measured from day of transplantation to day with granulocytes > 500/µl | — |
Countries
Germany
Outcome results
None listed