Status and phase
Conditions
Treatments
About
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent in accordance with federal, local, and institutional guidelines
Males and females ≥18 years of age
Histologically confirmed diagnosis of one of the hematologic malignancies below:
Subjects who are refractory or relapsed following at least two prior therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate cardiovascular function without symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months
Adequate hepatic function, with bilirubin < 2.0 times the upper limit of normal, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of < 3.0 times the upper limit of normal
Total white blood cell (WBC) count ≥ 2,000/mm³, absolute neutrophil count (ANC) ≥ 1000/mm³, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50,000/mm³
An estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault
Serum creatinine ≤ 2.0 mg/dL
Uric acid, if elevated, must be corrected to within laboratory normal range prior to dosing
Female subjects of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test. Male subjects must use an effective barrier method of contraception throughout the study and for three months following the last dose if sexually active with a female of child-bearing potential.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 11 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal