Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CuraGen Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older
Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.
Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
ECOG Performance Score of 2 or less
Signed Informed Consent Form (ICF)
You may not be if
Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
Patients with known hypersensitivity to recombinant protein therapeutics
Patients who have taken velafermin (CG53135-05) previously
Patients who have taken palifermin in the past 90 days
Patients who have taken other investigational drugs in the past 30 days
Patients who have untreated symptomatic dental infection
Patients with a history of sensitivity or allergy to E. coli-derived products
Patients with WHO Grade 3 or 4 OM at the time of randomization
Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.
