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

January 12, 2012 updated by: Millennium Pharmaceuticals, Inc.

An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1171
        • Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
  • Belgium
      • Antwerpen, Belgium, 2060
        • ACZA, Campus Stuivenberg
      • Brugge, Belgium, 8000
        • AZ St. Jan, Dept of Haematology
      • Brussels, Belgium, 1070
        • CHU Erasme / ULB University
      • Bruxelles, Belgium, 1000
        • Institue Jules Bordet, Unite Sterile
      • Charleroi, Belgium, 6000
        • C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5G2M9
        • Toronto General Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University Clinical Research Program
  • France
      • Cedex, France, 69495
        • Centre Hospitalier LYON SUD
      • Clamart, France, 92140
        • Hôpital Antoine Béclère
      • Paris, France, 75010
        • Hospital Saint-Louis
    • Cedex
      • Lile, Cedex, France, 59037
        • Hospital Claude Huriez
      • Paris, Cedex, France, 75181
        • Hoptial Hotel Dieu
      • Toulouse, Cedex, France, 31059
        • Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
      • Vandoeuvre, Cedex, France, 54511
        • Hôpital de Brabois
  • Germany
      • Berlin, Germany, 10098
        • Universitatsklinikum Charite Medizinische Klinik und Poliklinik
      • Bonn, Germany, 53127
        • Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
      • Erlangen, Germany, 91054
        • University of Erlangen-Nurenberg, Division of Hematology/Oncology
      • Hamburg, Germany, 20246
        • Medical University Clinic (Oncology/Haematology)
      • Heidelberg, Germany, 69115
        • Universitatsklinikum Heidelberg
      • Mainz, Germany, 55101
        • Johannes-Gutenberg-University Medical School, Department of Medicine III
      • Muenster, Germany, 48129
        • Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
  • Ireland
      • Belfast, Ireland, BT9 7AB
        • Belfast City Hospital, Haematology Department
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
  • Italy
      • Roma, Italy, 00161
        • Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
      • Torino, Italy, 10126
        • Azienda Ospedaliera, S. Giovanni Battista
  • Netherlands
      • Rotterdam, Netherlands, 3075
        • Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico Universitario de Barcelona, Hematologia
      • Salamanca, Spain, 37007
        • University Hospital of Salamanca, Hematology Dept
  • Sweden
      • Stockholm, Sweden, 14186
        • Huddinge University Hospital M54, Department of Haematology
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary, Department of Haematology
      • London, United Kingdom, W12 0NN
        • Department of Haematology, ICSM
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Adult Leukaemia Unit, Christie Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Sciences
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Duarte, California, United States, 91010
        • City of Hope
      • La Jolla, California, United States, 92307
        • Scripps Clinic, Green Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center, Georgetown University Medical Center
      • Washington, District of Columbia, United States, 20010
        • Med Star Institute
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Hematology/Oncology Associates, PA
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago,, Illinois, United States, 60611
        • Northwestern University Medical School
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center: Cardinal Bernardin Cancer Center
    • Louisiana
      • Sheveport, Louisiana, United States, 71130
        • LSU HC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Center
      • Boston, Massachusetts, United States, 02111
        • Tufts England Medical Center
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • Univ. of Michigan Comp. Cancer Center,
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center, David Jurist Research Building
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University, NY Presbyterian Hospital
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center, James P. Wilmot Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Charlotte Hematology Oncology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia,, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Palmetto Hematology/Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37232-5505
        • Division of Hematology/Stem Cell Transplant
    • Texas
      • Dallas, Texas, United States, 75225
        • Texas Oncology at Medical City Dallas Hospital
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patient experienced PD, as defined by SWOG+ criteria during or after treatment with high-dose dexamethasone in MPI Study M34101-039, but has not received alternate anti-neoplastic therapy. Intolerance to high-dose dexamethasone therapy as administered in MPI study M34101-039 does not qualify as PD.
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from Screening through the End of Treatment visit.
  • Male patient agrees to use an acceptable barrier method for contraception from Screening through the End of Treatment visit.
  • Patient meets the following pretreatment laboratory criteria at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration). (Note that the End of Treatment assessments of MPI study M34101-039 may qualify as the Screening assessments for MPI study M34101-040 if performed within 14 days of the Baseline visit.):
  • Platelet count ≥20 X 10E+9/L, with or without transfusion support.
  • Hemoglobin ≥7.0 g/dL, with or without transfusion support.
  • Absolute neutrophil count (ANC)≥0.5 x 10E+9/L, without growth factor support.
  • Serum calcium <14 mg/dL (3.5 mmol/L).
  • Aspartate transaminase (AST):≤2.5 x the upper limit of normal (ULN).
  • Alanine transaminase (ALT):≤2.5 x the ULN.
  • Total bilirubin:≤1.5 x the ULN.
  • If calculated or measured creatinine clearance: ≥20 mL/minute, assessments are as specified in the protocol. If calculated or measured creatinine clearance is <20 mL/minute.

Exclusion Criteria

  • Patient participated in M34101-039 and did not have confirmed PD. Dexamethasone intolerance does not qualify as PD.
  • Patient had PD on the dexamethasone arm of the MPI Study M34101-039, and then received alternate anti-neoplastic therapy.
  • Patient has not recovered from dexamethasone-related toxicity experienced during MPI Study M34101-039.
  • Patient is known to be human immunodeficiency virus (HIV)-positive.(Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations.)
  • Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.(Patients assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local regulations.)
  • Female patient is pregnant or breast-feeding.
  • Patient developed a new or experienced worsening of an existing illness during or after completion of Study M34101-039 that, in the investigator's opinion, may put the patient at risk of participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

July 2, 2003

First Submitted That Met QC Criteria

July 10, 2003

First Posted (Estimate)

July 11, 2003

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M34101-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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