Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Key facts

Study ID

NCT00153920

Run by

Dana-Farber Cancer Institute

People needed

66

Starts

2003-12-01

Expected to finish

2008-09-01

Last updated by the study team

2019-06-11

Who can join

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

You may qualify if…

• Diagnosis of multiple myeloma based upon standard criteria
• Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1 g/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
• Karnofsky performance status of > 60
• Hemoglobin > 8.0 g/dL
• AST (SGOT) < 3 x ULN
• ALT < 3 x ULN
• Total bilirubin < 2 x ULN
• Is infertile or is practicing an adequate form of contraception
• 18 years of age or older

You may not qualify if…

• Prior treatment with systemic chemotherapy
• Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes
• Plasma cell leukemia
• Calculated or measured creatinine clearance < 30 mL/minute within 14 days of enrollment
• Grade 2 or greater peripheral neuropathy
• Hypersensitivity to bortezomib, boron or mannitol
• Severe hypercalcemia
• HIV positive
• Known active hepatitis B or C
• New York Hospital Association Class III or IV heart failure
• Second malignancy requiring concurrent treatment
• Other serious medical or psychiatric illness
• Pregnant women
• Dialysis dependent patients

Where it is running

• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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