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

NCT ID: NCT00063726

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2005-07-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Locations

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 D.C., District of Columbia, United States

Med Star Institute

Washington D.C., District of Columbia, United States

Hematology/Oncology Associates, PA

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University Medical School

Chicago, Illinois, United States

Loyola University Medical Center: Cardinal Bernardin Cancer Center

Maywood, Illinois, United States

LSU HC

Sheveport, Louisiana, United States

Tufts England Medical Center

Boston, Massachusetts, United States

Mass General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Center

Boston, Massachusetts, United States

Univ. of Michigan Comp. Cancer Center,

Ann Arbor, Michigan, United States

VA Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center, David Jurist Research Building

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Weill Medical College of Cornell University, NY Presbyterian Hospital

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

University of Rochester Medical Center, James P. Wilmot Cancer Center

Rochester, New York, United States

Charlotte Hematology Oncology Associates

Charlotte, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Trident Palmetto Hematology/Oncology

Charleston, South Carolina, United States

Division of Hematology/Stem Cell Transplant

Nashville, Tennessee, United States

Texas Oncology at Medical City Dallas Hospital

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

Vienna, , Austria

ACZA, Campus Stuivenberg

Antwerp, , Belgium

AZ St. Jan, Dept of Haematology

Bruges, , Belgium

Institue Jules Bordet, Unite Sterile

Brussels, , Belgium

CHU Erasme / ULB University

Brussels, , Belgium

C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie

Charleroi, , Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

London Health Sciences Center

London, Ontario, Canada

Toronto General Research Institute

Toronto, Ontario, Canada

McGill University Clinical Research Program

Montreal, Quebec, Canada

Hospital Claude Huriez

Lille, Cedex, France

Hoptial Hotel Dieu

Paris, Cedex, France

Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

Toulouse, Cedex, France

Hopital de Brabois

Vandœuvre-lès-Nancy, Cedex, France

Centre Hospitalier Lyon Sud

Cedex, , France

Hopital Antoine Beclere

Clamart, , France

Hospital Saint-Louis

Paris, , France

Universitatsklinikum Charite Medizinische Klinik und Poliklinik

Berlin, , Germany

Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet

Bonn, , Germany

University of Erlangen-Nurenberg, Division of Hematology/Oncology

Erlangen, , Germany

Medical University Clinic (Oncology/Haematology)

Hamburg, , Germany

Universitatsklinikum Heidelberg

Heidelberg, , Germany

Johannes-Gutenberg-University Medical School, Department of Medicine III

Mainz, , Germany

Uniklinikum Muenster, Medizinische Klinik und Poliklinik A

Münster, , Germany

Belfast City Hospital, Haematology Department

Belfast, , Ireland

Hadassah University Hospital

Jerusalem, , Israel

Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1

Roma, , Italy

Azienda Ospedaliera, S. Giovanni Battista

Torino, , Italy

Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology

Rotterdam, , Netherlands

Hospital Clinico Universitario de Barcelona, Hematologia

Barcelona, , Spain

University Hospital of Salamanca, Hematology Dept

Salamanca, , Spain

Huddinge University Hospital M54, Department of Haematology

Stockholm, , Sweden

Adult Leukaemia Unit, Christie Hospital

Withington, Manchester, United Kingdom

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Leeds General Infirmary, Department of Haematology

Leeds, , United Kingdom

Department of Haematology, ICSM

London, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Austria; Belgium; Canada; France; Germany; Ireland; Israel; Italy; Netherlands; Spain; Sweden; United Kingdom

References

van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.

Reference Type: DERIVED

PMID: 21791470 (View on PubMed)

Other Identifiers

M34101-040

Identifier Type: -

Identifier Source: org_study_id

NCT00049478

Identifier Type: -

Identifier Source: nct_alias