Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Bortezomib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193557

208538

SCRI MM 06

Details and patient eligibility

About

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

Full description

Upon determination of eligibility, patients will be receive:

Bortezomib

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.