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| Title: |
A Phase II Study of Bortezomib (PS-341)and Pegylated Liposomal Doxorubicin as Initial Therapy for Patients with Symptomatic Multiple Myeloma |
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| Phase: |
II |
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| Purpose: |
Primary Objectives:
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To evaluate the complete response (CR) + near-complete response (nCR) rate of the bortezomib/pegylated loposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
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To evaluate the toxicity of the bortezomib/pegylated liposomal doxorubicin regimen in patients with previously untreated, symptomatic multiple myeloma.
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| Eligibility: |
(Abbreviated List):
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A diagnosis of symptomatic multiple myeloma
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No prior treatment for multiple myeloma
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Age >/= 18 years
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Non-pregnant and non-nursing
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ECOG PS of 0, 1, or 2
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No hypersensitivity to bortezomib, other proteasome inhibitors, boron-based compounds, doxorubicin, pegylated liposomal doxorubicin, or the liposomal portion of another liposomal agent
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Patients may not be HIV+ and taking anti-retroviral therapy
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No active uncontrolled infection, hepatitis A, B, or C
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Adequate cardiac function: no myocardial infarction within 6 months; no class 3 or 4 NYHA CHF, LVEF >/= 45%, no EKG evidence of ischemia, or new conduction system abnormalities
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ANC >/= 1000
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Platelets >/= 100,000
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Hemoglobin >/= 8
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Creatinine < 2.5 mg/dl or estimated clearance of >/= 30 ml/min
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ALT and AST
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Therapeutic value of PT (INR) or a PTT for patients on anticoagulation
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Bilirubin
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| Contact: |
Missouri
St. Louis, MO
Nicholas Fisher
Supervisor, Clinical Research
Bone Marrow Transplant & Leukemia
Division of Oncology
Washington University School of Medicine
314.454.5102 (phone)
nfisher@im.wustl.edu
St. Louis, MO
Dr. Ravi Vij
Siteman Cancer Center at Barnes-Jewish Hospital
314-454-8508
New Hampshire
Manchester, NH
Dr. Douglas J. Weckstein
Elliot Regional Cancer Center
603-663-4201
North Carolina
Goldsboro, NC
Dr. James N. Atkins
Wayne Memorial Hospital
614-293-9808
Winston Salem, NC
Dr. David D. Hurd
Comprehensive Cancer Center at Wake Forest University
336-716-2088
South Carolina
Greenville, SC
Dr. Jeffrey Giguere
Bon Secours St. Francis Health System
Greenville Community Clinical Oncology Program
Greenville Hospital System Cancer Center
864-241-6251
Washington D.C.
Washington, DC
Dr. Thomas J. Reid
Walter Reed Army Medical Center
202-782-5762
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