Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function

Completed · Phase 2

Conditions studied: Multiple Myeloma, Renal Insufficiency

In brief

The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).

Key facts

Study ID

NCT00721734

Run by

Amgen

People needed

50

Starts

2008-11-01

Expected to finish

2012-11-01

Last updated by the study team

2017-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California- San Francisco — San Francisco, California, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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