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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-01-31

Brief Summary

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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

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Detailed Description

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Upon determination of eligibility, patients will be receive:

* Bortezomib

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bortezomib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No