A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
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
1 other identifier
interventional
600
13 countries
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Apr 2002
Shorter than P25 for phase_3 multiple-myeloma
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 2, 2003
CompletedFirst Posted
Study publicly available on registry
July 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedJanuary 13, 2012
January 1, 2012
3.1 years
July 2, 2003
January 12, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
University of Arkansas Medical Sciences
Little Rock, Arkansas, 72205, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
City of Hope
Duarte, California, 91010, United States
Scripps Clinic, Green Cancer Center
La Jolla, California, 92307, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Med Star Institute
Washington D.C., District of Columbia, 20010, United States
Hematology/Oncology Associates, PA
Jacksonville, Florida, 32207, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Loyola University Medical Center: Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
LSU HC
Sheveport, Louisiana, 71130, United States
Tufts England Medical Center
Boston, Massachusetts, 02111, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Center
Boston, Massachusetts, 02115, United States
Univ. of Michigan Comp. Cancer Center,
Ann Arbor, Michigan, 48109-0922, United States
VA Medical Center
Minneapolis, Minnesota, 55417, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center, David Jurist Research Building
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
Weill Medical College of Cornell University, NY Presbyterian Hospital
New York, New York, 10021, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Charlotte Hematology Oncology Associates
Charlotte, North Carolina, 28203, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Trident Palmetto Hematology/Oncology
Charleston, South Carolina, 29406, United States
Division of Hematology/Stem Cell Transplant
Nashville, Tennessee, 37232-5505, United States
Texas Oncology at Medical City Dallas Hospital
Dallas, Texas, 75225, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
Vienna, 1171, Austria
ACZA, Campus Stuivenberg
Antwerp, 2060, Belgium
AZ St. Jan, Dept of Haematology
Bruges, 8000, Belgium
Institue Jules Bordet, Unite Sterile
Brussels, 1000, Belgium
CHU Erasme / ULB University
Brussels, 1070, Belgium
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
Charleroi, 6000, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
London Health Sciences Center
London, Ontario, N6A 4G5, Canada
Toronto General Research Institute
Toronto, Ontario, M5G2M9, Canada
McGill University Clinical Research Program
Montreal, Quebec, H2W 1S6, Canada
Hospital Claude Huriez
Lille, Cedex, 59037, France
Hoptial Hotel Dieu
Paris, Cedex, 75181, France
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
Toulouse, Cedex, 31059, France
Hopital de Brabois
Vandœuvre-lès-Nancy, Cedex, 54511, France
Centre Hospitalier Lyon Sud
Cedex, 69495, France
Hopital Antoine Beclere
Clamart, 92140, France
Hospital Saint-Louis
Paris, 75010, France
Universitatsklinikum Charite Medizinische Klinik und Poliklinik
Berlin, 10098, Germany
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
Bonn, 53127, Germany
University of Erlangen-Nurenberg, Division of Hematology/Oncology
Erlangen, 91054, Germany
Medical University Clinic (Oncology/Haematology)
Hamburg, 20246, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69115, Germany
Johannes-Gutenberg-University Medical School, Department of Medicine III
Mainz, 55101, Germany
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
Münster, 48129, Germany
Belfast City Hospital, Haematology Department
Belfast, BT9 7AB, Ireland
Hadassah University Hospital
Jerusalem, 91120, Israel
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
Roma, 00161, Italy
Azienda Ospedaliera, S. Giovanni Battista
Torino, 10126, Italy
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
Rotterdam, 3075, Netherlands
Hospital Clinico Universitario de Barcelona, Hematologia
Barcelona, 08036, Spain
University Hospital of Salamanca, Hematology Dept
Salamanca, 37007, Spain
Huddinge University Hospital M54, Department of Haematology
Stockholm, 14186, Sweden
Adult Leukaemia Unit, Christie Hospital
Withington, Manchester, M20 4BX, United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Leeds General Infirmary, Department of Haematology
Leeds, LS1 3EX, United Kingdom
Department of Haematology, ICSM
London, W12 0NN, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 21791470DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 2, 2003
First Posted
July 11, 2003
Study Start
April 1, 2002
Primary Completion
May 1, 2005
Study Completion
July 1, 2005
Last Updated
January 13, 2012
Record last verified: 2012-01