PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

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

An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

This study will compare the efficacy of PS-341 versus high dose dexamethasone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

620

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
      • Brussels, Belgium, 1070
        • CHU Erasme / ULB University, Hematology 7th Floor
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet, Unite Sterile
      • Charleroi, Belgium, 6000
        • C.H. Notre Dame-Reine Fabiola
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg, Department of Hematology
      • Rugge, Belgium, 8000
        • AZ St. Jan, Dept. of Haematology
      • Yvoir, Belgium, 5530
        • Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour
  • 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, Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • Royal Victoria Hospital
  • France
      • Clamart, France, 92140
        • Hopital Antoine Beclere, Hopital de Jour de Medecine Interne
      • Paris, France, 75004
        • Hopital Hotel Dieu, Service d'hematologie et oncologie medicale
      • Paris, France, 75010
        • Hopital Saint-Louis, Direction Financiere
      • Paris, France, 75014
        • Hopital Cochin, Service de Hematologie
      • Pierre Benite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
      • Vandoeuvre, France, 54511
        • Hopital de Brabois, Service Hematologie et Medecine Interne
    • Cedex
      • Lile, Cedex, France, 59037
        • Hospital Claude Huriez, Service des Maladies du Sang
      • Nantes, Cedex, France, 01 44093
        • Nantes Hotel Dieu Hospital
      • Toulouse, Cedex, France, 31059
        • Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
      • Villejuif, Cedex, France, 94805
        • Institut Gustave-Roussy, Service d'Hematologie
  • Germany
      • Berlin, Germany, 10098
        • Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie
      • Bonn, Germany, 53127
        • Medizinische Klinik und Poliklinik 1
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Erlangen, Germany, 91054
        • University of Erlangen-Nurenberg, Division of Hematology/Oncology
      • Freiburg, Germany, 79106
        • Freiburg University Medical Center, Dept. of Hemayology/Oncology
      • Hamburg, Germany, 20246
        • Medical University Clinic (Oncology/Haematology)
      • Hamm, Germany, 59071
        • St. Marien Hospital, Klinik fur Hamatologie und Onkologie
      • Heidelberg, Germany, 69115
        • Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie
      • Hufelandstr, Germany, 55 45122
        • University of Essen Medical School, Dept. of Internal Medicine
      • Mainz, Germany, 55101
        • Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik
      • Muenster, Germany, 48129
        • Uniklinikum Muenster
      • Tubingen, Germany, 72076
        • Eberhard-Karls Universitat, Medizinische Klinik
  • Ireland
      • Belfast, Ireland, BT9 7AB
        • Belfast City Hospital
  • Israel
      • Haifa, Israel, 31096
        • RAMBAM Medical Center, Department of Hematology and Bone
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
  • Italy
      • Bergamo, Italy, 24128
        • Dipartmento Clinico esperimentale Di Oncologia et Ematolgia
      • Bologna, Italy, 40138
        • Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli
      • Roma, Italy, 00161
        • Dipartimento di Biotecnologie Cellulari ed Ematologia
      • Torino, Italy, 10126
        • Azienda Ospedaliera, S. Giovanni Battista
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Dept. of Clinical Hematology, Academic Medical Center
      • Rotterdam, Netherlands, 3075
        • Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed
      • Utrecht, Netherlands, 3584 CX
        • Dept. Hematology, University Medical Centre
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico Universitario de Barcelona, Haematology Department
      • Salamanca, Spain, 37007
        • University Hospital of Salamanca
  • Sweden
      • Stockholm, Sweden, 14186
        • Department of Haematology, Huddinge University Hospital M54
      • Stockholm, Sweden, 17176
        • Karolinska Hospital, Dept. of Hematology
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Department of Haematology, Queen Elizabeth Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • London, United Kingdom, EC1A 7BE
        • Department of Haematology, St. Bartholomew's Hospital
      • London, United Kingdom, W12 0NN
        • Department of Haematology, ICSM, Hammersmith Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital, Leukaemia and Myeloma Units
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Adult Leukaemia Unit, Christie Hospital
  • United States
    • 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
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Oncology Clinical Trials
    • 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, Washington Cancer Center
    • 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, University of S. Florida
    • 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
      • Shreveport, Louisiana, United States, 71130
        • LSU HC
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts New England Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Center
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center, Kirstein Room 135
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center, Sections of Hematology/Oncology
      • 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, Division of Hematology/Oncology
      • New York, New York, United States, 10021
        • NY Presbyterian Hospital
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center, Research Department
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center, James P. Wilmot Cancer Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital, Lipson Cancer Blood Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas 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, Dept. of Human Oncology
    • 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
      • Dallas, Texas, United States, 75246
        • Baylor Institute for Immunology Research
      • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patient is of a legally consenting age, as defined by local regulations.
  • 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 either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male patient agrees to use an acceptable method for contraception for the duration of the study.
  • Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second-, third-, or fourth-line therapy because of PD, defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or relapse from CR.
  • Patient has measurable disease, defined as follows:
  • For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, greater than 1 g/dL of IgG M-Protein and greater than 0.5g/dL IgA) and, where applicable, urine light-chain excretion of ≥200 mg/24 hours.
  • For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessments. Therefore, other disease sites (bone marrow; extramedullary mass) must be assessed and followed. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation.
  • Patient has a Karnofsky performance status ≥60%.
  • Patient has a life-expectancy >3 months.
  • Patient has the following laboratory values at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration):
  • Platelet count ≥50 x 10E+9/L without transfusion support within 7 days before the laboratory test.
  • Hemoglobin ≥7.5 g/dL, without transfusion support within 7 days before the laboratory test.
  • Absolute neutrophil count (ANC) ≥0.75 x 10E+9/L without the use of colony stimulating factors.
  • Corrected 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.
  • Calculated or measured creatinine clearance: ≥20 mL/minute.

Exclusion Criteria

  • Patient previously received treatment with VELCADE.
  • Patient previously was refractory to treatment with high-dose dexamethasone, as experiencing less than a partial response to or PD within 6 months after discontinuing dexamethasone, or discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity.
  • Previous high-dose dexamethasone therapy is defined as >500 mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen.
  • Patient received nitrosoureas within 6 weeks or any other chemotherapy, including thalidomide or clarithromycin, or radiation therapy within 3 weeks before enrollment.
  • Patient received corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
  • Patient received immunotherapy or antibody therapy within 8 weeks before enrollment.
  • Patient received plasmapheresis within 4 weeks before enrollment.
  • Patient had major surgery within 4 weeks before enrollment. (Kyphoplasty is not considered major surgery.)
  • Patient has a history of allergic reaction attributable to compounds containing boron or mannitol.
  • Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC):
  • Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs).
  • Grade 3: Sensory loss or paresthesia interfering with ADLs.
  • Grade 4: Permanent sensory loss that interferes with function.
  • Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Patient was treated for a cancer other than multiple myeloma within 5 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
  • Patient has cardiac amyloidosis.
  • Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • 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.
  • Patient has an active systemic infection requiring treatment.
  • Female patient is pregnant or breast-feeding.
  • Patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

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
  • Masking: NONE

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

June 1, 2002

Primary Completion (ACTUAL)

July 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

October 28, 2002

First Submitted That Met QC Criteria

October 29, 2002

First Posted (ESTIMATE)

October 30, 2002

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

  • M34101-039

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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