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About
This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
Full description
This study is a multi-site study which will enroll up to 50 patients with multiple myeloma who have not had prior treatment.
Prior to starting treatment individuals will be evaluated to determine if they are eligible to participate in the study. There are certain prestudy test that are required: physical exam, blood tests, ECG, chest x-ray, skeletal survey, bone marrow aspirate and biopsy to confirm the diagnosis of multiple myeloma and to determine baseline health status.
Before beginning each treatment cycle and at the end of the study, patients will have protein studies (including blood and urine) to see if they are responding to the treatment. Before each weekly treatment cycle patients will also have blood tests for red and white blood cells and platelets, and blood chemistry tests for electrolytes, kidney and liver function, calcium and blood sugar.
Patients may receive up to 6 cycles of treatment. At the end of the study, individuals who have responded to treatment will be seen every two months to check for disease progression.
Enrollment
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Volunteers
Inclusion criteria
Diagnosis of multiple myeloma based on standard criteria.
Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
Age>65
Impaired renal function (creatinine≥2.0 mg/dL)
Impaired pulmonary function (DLCO≤50%)
Poor performance status (KPS≤80)
Other prohibitive comorbid disorder
Karnofsky performance status>50
Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry.
Meets the following pretreatment laboratory criteria at Baseline (Within 14 days prior to study drug administration):
Meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration
Women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Age 18 years or older
Has given voluntary written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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