This trial is active, not recruiting.

Condition multiple myeloma
Treatment bortezomib
Phase phase 2
Target proteasome
Sponsor Dana-Farber Cancer Institute
Collaborator Beth Israel Deaconess Medical Center
Start date December 2003
End date July 2014
Trial size 66 participants
Trial identifier NCT00153920, 03-328


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants will receive intravenous bortezomib on a 3 week dosing cycle. Velcade will be given twice a week for 2 weeks (on days 1,4,8 and 11) followed by a 10 day rest period (days 12-21).
bortezomib Velcade
Given intravenously twice a week for 2 weeks (days 1, 4, 8, 11) followed by a 10-day rest period (days 12-21) for up to eight 3-week treatment cycles.

Primary Outcomes

To evaluate the objective response to Velcade (bortezomib) alone in patients with newly diagnosed multiple myeloma.
time frame: 2 years

Secondary Outcomes

To evaluate the safety of bortezomib in patients with newly diagnosed multiple myeloma
time frame: 2 years
evaluate time to disease progression following bortezomib treatment
time frame: TBD
assess the frequency and severity of peripheral neuropathy in this patient population.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
Principal investigator Paul Richardson, MD
Description - Patients will receive intravenous Velcade on a 3 week dosing cycle. Velcade will be given twice a week for 2 weeks (on days 1,4,8 and 11) followed by a 10 day rest period (days 12-21). - On the days patients receive Velcade a physical exam, vital signs, and blood tests will be performed. A neurotoxicity-directed questionnaire will be completed once during each cycle of therapy. - A patient may undergo up to eight 3-week dosing cycles. During the dosing phase, if after two cycles of dosing, tests indicate progressive disease the patient will be removed from the study. - A complete response means that all traces of the disease have disappeared: there are no abnormal proteins in the blood or urine; no traces of abnormal cells in bone marrow or any other place; and no worsening of bone tumors are found. Confirmation of this will be obtained at least 6 weeks after initial testing by a bone marrow biopsy. - An end of dosing phase visit will occur 30 days after the last study dose; or 2 dosing cycles following the time it is confirmed that there is complete response; or at the time it is confirmed that the disease has worsened. - After the end of the study visits, patients will be asked to participate in follow-up telephone calls every 6 weeks. - Whole-genome scanning and nerve fiber studies are optional research studies for patients enrolled in the dosing phase. The whole-genome scanning portion involves collection of a bone marrow biopsy at the start and end of the study. The nerve fiber study involves skin biopsies at the next study visit after neuropathy is reported and at the end of the study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.