Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Barbara Ann Karmanos Cancer Institute
With
Eisai Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
All patients age \> =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility.
1. Diagnosis of Multiple Myeloma
2. Age \>=18 and no more than 70 years.
3. Able to understand and sign a consent form.
4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells.
5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2.
6. Karnofsky Performance Score (KPS) \>60 or ECOG (Eastern Cooperative Oncology Group) performance status \<=2
7. Kidney function:Creatinine \<2.0 mg/dl or creatinine clearance \>50 ml/min
8. Heart function: Ejection fraction \>45%
9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \>45% predicted
You may not be if
1. Age \<18 years or \> 70 years
2. Previous exposure to denileukin diftitox.
3. Patients with documented uncontrolled central nervous system (CNS) disease.
4. Previous AHSCT.
5. Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
