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:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT00352703
Eligibility Criteria:
Inclusion Criteria:
* Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT
* ≥Age 18 years
* ECOG performance status \<= 2. In the MM group, ECOG status \>2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)
* Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Minimum of 1.5 x 10\^6 CD34+ cells/kg for autologous transplantation
* Adequate haematological function (ANC ≥ 1.5 x 10\^9/L and platelet count ≥ 100 x 10\^9/L)
* Serum creatinine \<= 2.0 mg/dL
* Total bilirubin \<= 2 mg/dL
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 4.0 x IULN
* Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment
* Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:
* History of or concurrent cancer other than NHL or MM
* Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants
* Oral abnormalities defined as baseline oral assessment of WHO grade \>0
* Other investigational procedures are excluded
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
* Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
* Subject is not using adequate contraceptive precautions
* Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products
* Subject has previously been treated on this study or with other keratinocyte growth factors
* Unwilling or unable to complete the patient-reported outcome questionnaires
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00352703
Study Brief:
Protocol Section:
NCT00352703