Status:
COMPLETED
Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function
Lead Sponsor:
Amgen
Conditions:
Multiple Myeloma
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).
Eligibility Criteria
Inclusion
- Written informed consent in accordance with federal, local, and institutional guidelines
- Males and females ≥ 18 years of age
- Multiple Myeloma
- Documented relapsed or progressive disease (PD) after receiving at least two prior treatment regimens (induction therapy with autologous stem cell transplant and maintenance is considered a single regimen), and must have achieved a minimal response or better to at least one of the regimens
- Current measurable disease, as indicated by one or more of the following:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Serum Free Light Chain (FLC) assay: Involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal
- Life expectancy of more than three months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate hepatic function, with bilirubin \< 2 times the upper limit of normal (ULN) and alanine aminotransferase (ALT) \< 3 times ULN
- Total white blood cell (WBC) count ≥ 2,000/mm³
- Absolute neutrophil count (ANC) ≥ 1,000/mm³
- Hemoglobin ≥ 7 gm/dL
- Subjects may receive red blood cell (RBC) transfusions or supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
- Platelet count ≥ 30,000/ mm³
- Female subjects of child-bearing potential must have a negative serum pregnancy test within seven days of the first dose and agree to use dual methods of contraception during and for 3 months following last dose of drug. Post menopausal females (\> 45 years old and without menses for \> 1 year) and surgically sterilized females are exempt from a pregnancy test
- Male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential
Exclusion
- Glucocorticoid therapy in a dose equivalent to prednisone ≥ 20 mg/day within 14 days prior to first dose of study drug
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia
- Chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 14 days prior to first dose of study drug or antibody therapy within 6 weeks prior to first dose of study drug
- Radiation therapy or immunotherapy within 3 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
- Participation in an investigational therapeutic study within 14 days prior to first dose of study drug
- Prior carfilzomib treatment
- Pregnant or lactating females
- Major surgery within 3 weeks prior to first dose of study drug
- Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities or myocardial infarction in the three months prior to first dose of study drug
- Uncontrolled hypertension
- Recent history of acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose of study drug
- Known or suspected human immunodeficiency virus (HIV) infection, known HIV seropositivity
- Active hepatitis A, B, or C infection
- Other malignancy within the past 3 years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer \< Gleason Grade 7 with stable prostate specific antigen (PSA) levels
- Any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days prior to enrollment
- Subjects in whom the required program of oral hydration and intravenous fluid hydration is contraindicated, e.g., due to preexisting pulmonary or cardiac impairment
- Subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
- Subjects with a known contraindication to receiving dexamethasone or allopurinol
- Receipt of granulocyte- and granulocyte/ macrophage- colony stimulating factor (G-CSF and GM-CSF) within 1 week prior to first dose of study drug
- Receipt of pegylated G-CSF within 2 weeks prior to first dose of study drug
- RBC and platelet transfusions within 7 days prior to first dose of study drug
- Subjects with known or suspected cardiac amyloidosis
- Subjects with myelodysplastic syndrome
- Subjects undergoing peritoneal dialysis
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00721734
Start Date
November 1 2008
End Date
November 1 2012
Last Update
May 2 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California- San Francisco
San Francisco, California, United States, 94143
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110