Multiple Myeloma
Conditions
Brief summary
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib
Detailed description
Upon determination of eligibility, patients will be receive: * Bortezomib
Interventions
DRUGBortezomib
Sponsors
Millennium Pharmaceuticals, Inc.
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Multiple Myeloma * Received no more than 2 previous treatment regimens for multiple Myeloma * ECOG performance status 0, 1, or 2 * Serum creatinine \< 2.0mg/dL * calculated or measured creatinine clearance \> 30ml/minute * Measurable or evaluable disease * Provide written informed consent prior to receiving protocol therapy.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Moderate or severe peripheral neuropathy * Other serious medical conditions * Other active malignancies * history of treatment for other invasive cancers * Women who are pregnant or lactating Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
| overall survival | — |
| Safety | — |
Countries
United States
Outcome results
None listed