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Clinical Trials/NCT00193557
NCT00193557CompletedPhase 2

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

SCRI Development Innovations, LLC2 sites in 1 country40 target enrollmentStarted: May 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
objective response rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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/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.

Outcomes

Primary Outcomes

objective response rate

Secondary Outcomes

  • overall survival
  • Safety
  • progression-free survival

Investigators

Sponsor Class
Other

Study Sites (2)

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