Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2003 |
| End Date: | September 2008 |
Phase II Trial of Velcade (Bortezomib) in Patients With Previously Untreated Multiple Myeloma
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.
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.
Primary Objective
• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with
newly diagnosed multiple myeloma.
Secondary Objectives
- To evaluate the tolerability and toxicity.
- To evaluate time to progression.
- To assess the frequency and severity of peripheral neuropathy.
- To evaluate the impact of early intervention with dose modification and explore
symptomatic treatment of peripheral neuropathy.
Exploratory Objectives
• To perform pharmacogenomic analysis of molecular markers associated with response or
non-response.
Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable
participants, if at least 27 objective responses are observed then bortezomib will be
considered promising. The probability of concluding the treatment promising is >0.95 with a
true ORR of 55% and <0.07 with a true ORR of 35%.
• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with
newly diagnosed multiple myeloma.
Secondary Objectives
- To evaluate the tolerability and toxicity.
- To evaluate time to progression.
- To assess the frequency and severity of peripheral neuropathy.
- To evaluate the impact of early intervention with dose modification and explore
symptomatic treatment of peripheral neuropathy.
Exploratory Objectives
• To perform pharmacogenomic analysis of molecular markers associated with response or
non-response.
Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable
participants, if at least 27 objective responses are observed then bortezomib will be
considered promising. The probability of concluding the treatment promising is >0.95 with a
true ORR of 55% and <0.07 with a true ORR of 35%.
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
We found this trial at
6
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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