Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.

Key facts

Study ID

NCT00511238

Run by

Amgen

People needed

312

Starts

2007-08-01

Expected to finish

2012-10-01

Last updated by the study team

2017-08-31

Who can join

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

You may qualify if…

• Disease Related
• Multiple myeloma
• Subjects must have measurable disease defined as one of the following:
• Serum M-protein ≥ 1 g/dL
• Urine M-protein ≥ 200 mg/24 hours
• Serum FLC ≥ 10 mg/dL with abnormal ratio (A0 Only)
• Quantitative immunoglobulin levels using nephelometry or turbidometry (only if protein electrophoresis was felt to be unreliable for M-protein measurement) (A0 Only)
• Subjects must have been responsive (i.e., achieved an MR or better) to first-line, standard of care therapy
• Refractory to the most recently received therapy. Refractory disease is defined as ≤ 25% response or progression during therapy or within 60 days after completion of therapy.
• Subjects must have received ≥ 2 prior regimens for relapsed disease. Induction therapy and stem cell transplant will be considered as one regimen (A1 Only)
• Subjects must have received prior treatment with bortezomib, and either thalidomide or lenalidomide
• Subjects must have received an alkylating agent either alone or in combination with other myeloma treatments (history of stem cell transplant is acceptable) (A1 Only)
• Subjects must have received an anthracycline either alone or in combination with other myeloma treatments, unless not clinically indicated (A1 Only)
• Demographic
• Males and females > 18 years of age
• Life expectancy of more than three months
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Laboratory
• Adequate hepatic function, with bilirubin less than 2.0 times the upper limit of normal, and AST and ALT of less than 3.0 times the upper limit of normal
• Uric acid within normal range (A0 Only)
• Total white blood cell (WBC) count ≥ 2.0 × 109/L, absolute neutrophil count (ANC) ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50.0 × 109/L (A0 Only)
• Absolute neutrophil count > 1,000/mm3, hemoglobin > 8.0 g/dL, and platelet count > 50,000/mm3 (A1 Only)
• Subjects should be platelet transfusion independent
• Screening ANC should be independent of G-CSF or GM-CSF support for ≥ 1 week and of pegylated G-CSF for ≥ 2 weeks
• Subjects may receive red blood cell (RBC) or platelet transfusions or receive supportive care such as erythropoietin and darbepoetin in accordance with institutional guidelines

You may not qualify if…

• Disease Related
• Multiple Myeloma IgM (A1 Only)
• Subjects who failed to achieve at least a confirmed MR(≥ 25% reduction in M-protein for ≥ 6 weeks) (A1 Only)
• Subjects with non-secretory multiple myeloma, defined as < 1 g/dL M-protein in serum and < 200 mg/24 hr M-protein in urine
• Subjects with disease measurable only by serum free light chain (SFLC) analysis (A1 Only)
• Glucocorticoid therapy (prednisone > 10 mg/day orally or equivalent) within the last three weeks
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Plasma cell leukemia
• Chemotherapy with approved or investigative anticancer therapeutics including steroid therapy within the three weeks prior to first dose
• Radiation therapy or immunotherapy in the previous four weeks; localized radiation therapy within 1 week prior to first dose
• Participation in an investigational therapeutic study within three weeks or within five drug half-lives (t1/2) prior to Day 1, whichever time is greater
• Prior treatment with carfilzomib
• Concurrent Conditions
• Major surgery within three weeks before Day 1
• Congestive heart failure (New York Heart Association class III to IV), symptomatic cardiac ischemia, cardiomyopathy, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months, LVEF < 40
• Acute active infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose
• Known or suspected HIV infection or subjects who are HIV seropositive
• Active hepatitis A,B,or C infection
• Non-hematologic malignancy within the past three 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 6 with stable PSA
• Subjects with treatment related myelodysplastic syndrome
• Significant neuropathy (Grade 3, 4 or Grade 2 with pain) at the time of study initiation
• Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac or renal impairment (A1 Only)
• Subjects with known or suspected amyloidosis (A1 Only)
• Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis (A1 Only)
• Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent (A1 Only)

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern Universtiy — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• St. Vincent Catholic Medical Center — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Oncology & Hematology Care — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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