Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01085058
Eligibility Criteria:
Inclusion Criteria:
* Presence of histologically proven lymphoproliferative disease specified as Hodgkin's disease, non-Hodgkin's lymphoma (NHL) or multiple myeloma
* Indication of high-dose therapy and autologous peripheral blood stem cell transplantation
* Availability of a sufficient amount of blood stem cells (CD34+ cells \>= 2.0 x 106/kg)
* Age between 18 and 70 years
* High-dose therapy with one of the following high-dose regimes: Melphalan 140 mg/m2 or 200 mg/m2, BEAM, BEAC, BUCY or CBV (the last permitted according to amendment 2, see Section 9.8.1)
* Patient's written consent to participation in this trial
Exclusion Criteria:
* Previous high-dose therapy and blood stem cell transplantation except for melphalan 140 mg/m2 or 200 mg/m2 in patients with multiple myeloma who did not participate in the cytocapacity test previously (according to amendment 2, see Section 9.8.1).
* Known intolerance to lenograstim
* Out-patient therapy following high-dose therapy and blood stem cell transplantation
* Myocardial infarction \< 6 months prior to inclusion into the study
* Cardiac arrhythmias Lown IV b
* Clinically manifest cardiac insufficiency (\> NYHA II)
* Renal insufficiency with serum creatinine \> 2 mg%
* Hepatic diseases with elevated levels of transaminases and bilirubin greater than 3-fold above normal
* Severe infections (HIV, Hepatitis B/C)
* Severe psychiatric diseases
* Non-curative treatment of other malignoma within the past 5 years
* Pregnant women or women breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01085058
Study Brief:
Protocol Section:
NCT01085058