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A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

Phase 3
Completed
Conditions
Multiple Myeloma
Registration Number
NCT00063726
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Brief Summary

The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

Detailed Description

The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
600
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (76)

University of Arkansas Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Alta Bates Comprehensive Cancer Center

🇺🇸

Berkeley, California, United States

City of Hope

🇺🇸

Duarte, California, United States

Scripps Clinic, Green Cancer Center

🇺🇸

La Jolla, California, United States

Loma Linda University Medical Center

🇺🇸

Loma Linda, California, United States

Kaiser Permanente Medical Center

🇺🇸

Vallejo, California, United States

Lombardi Cancer Center, Georgetown University Medical Center

🇺🇸

Washington, District of Columbia, United States

Med Star Institute

🇺🇸

Washington, District of Columbia, United States

Hematology/Oncology Associates, PA

🇺🇸

Jacksonville, Florida, United States

University of Miami

🇺🇸

Miami, Florida, United States

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University of Arkansas Medical Sciences
🇺🇸Little Rock, Arkansas, United States

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