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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063726
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : January 13, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib Phase 3

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  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2002
Actual Primary Completion Date : May 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00063726

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00063726     History of Changes
Obsolete Identifiers: NCT00049478
Other Study ID Numbers: M34101-040
First Posted: July 11, 2003    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Millennium Pharmaceuticals, Inc.:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Disease Progression
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists