Status:
TERMINATED
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
Eisai Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalatio...
Eligibility Criteria
Inclusion
- 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.
- Patients must fulfill all of the following inclusion criteria to be eligible for this study:
- Diagnosis of Multiple Myeloma
- Age \>=18 and no more than 70 years.
- Able to understand and sign a consent form.
- 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.
- Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2.
- Karnofsky Performance Score (KPS) \>60 or ECOG (Eastern Cooperative Oncology Group) performance status \<=2
- Kidney function:Creatinine \<2.0 mg/dl or creatinine clearance \>50 ml/min
- Heart function: Ejection fraction \>45%
- Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
- 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
Exclusion
- Age \<18 years or \> 70 years
- Previous exposure to denileukin diftitox.
- Patients with documented uncontrolled central nervous system (CNS) disease.
- Previous AHSCT.
- Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01251952
Start Date
November 1 2010
End Date
May 1 2013
Last Update
June 20 2017
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379