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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed Multiple Myeloma, Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Sites / Locations

  • University of Arkansas Medical Sciences
  • Alta Bates Comprehensive Cancer Center
  • City of Hope
  • Scripps Clinic, Green Cancer Center
  • Loma Linda University Medical Center
  • Kaiser Permanente Medical Center
  • Lombardi Cancer Center, Georgetown University Medical Center
  • Med Star Institute
  • Hematology/Oncology Associates, PA
  • University of Miami
  • H. Lee Moffitt Cancer Center
  • Emory University
  • Northwestern University Medical School
  • Loyola University Medical Center: Cardinal Bernardin Cancer Center
  • LSU HC
  • Tufts England Medical Center
  • Mass General Hospital
  • Dana-Farber Cancer Center
  • Univ. of Michigan Comp. Cancer Center,
  • VA Medical Center
  • Mayo Clinic
  • Washington University School of Medicine
  • Hackensack University Medical Center, David Jurist Research Building
  • Roswell Park Cancer Institute
  • Long Island Jewish Medical Center
  • St. Vincent's Comprehensive Cancer Center
  • Weill Medical College of Cornell University, NY Presbyterian Hospital
  • Rochester General Hospital
  • University of Rochester Medical Center, James P. Wilmot Cancer Center
  • Charlotte Hematology Oncology Associates
  • Cleveland Clinic Foundation
  • University of Pennsylvania Cancer Center
  • Western Pennsylvania Hospital
  • Trident Palmetto Hematology/Oncology
  • Division of Hematology/Stem Cell Transplant
  • Texas Oncology at Medical City Dallas Hospital
  • MD Anderson Cancer Center
  • Fred Hutchinson Cancer Center
  • Medical College of Wisconsin
  • Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
  • ACZA, Campus Stuivenberg
  • AZ St. Jan, Dept of Haematology
  • CHU Erasme / ULB University
  • Institue Jules Bordet, Unite Sterile
  • C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
  • Cross Cancer Institute
  • London Health Sciences Center
  • Toronto General Research Institute
  • McGill University Clinical Research Program
  • Hospital Claude Huriez
  • Hoptial Hotel Dieu
  • Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
  • Hopital de Brabois
  • Centre Hospitalier Lyon Sud
  • Hopital Antoine Beclere
  • Hospital Saint-Louis
  • Universitatsklinikum Charite Medizinische Klinik und Poliklinik
  • Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
  • University of Erlangen-Nurenberg, Division of Hematology/Oncology
  • Medical University Clinic (Oncology/Haematology)
  • Universitatsklinikum Heidelberg
  • Johannes-Gutenberg-University Medical School, Department of Medicine III
  • Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
  • Belfast City Hospital, Haematology Department
  • Hadassah University Hospital
  • Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
  • Azienda Ospedaliera, S. Giovanni Battista
  • Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
  • Hospital Clinico Universitario de Barcelona, Hematologia
  • University Hospital of Salamanca, Hematology Dept
  • Huddinge University Hospital M54, Department of Haematology
  • Adult Leukaemia Unit, Christie Hospital
  • Queen Elizabeth Hospital
  • Leeds General Infirmary, Department of Haematology
  • Department of Haematology, ICSM
  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2003
Last Updated
January 12, 2012
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00063726
Brief Title
A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Arkansas Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Scripps Clinic, Green Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92307
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Lombardi Cancer Center, Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Med Star Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Hematology/Oncology Associates, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago,
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center: Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
LSU HC
City
Sheveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Tufts England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mass General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Univ. of Michigan Comp. Cancer Center,
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0922
Country
United States
Facility Name
VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center, David Jurist Research Building
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Weill Medical College of Cornell University, NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
University of Rochester Medical Center, James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Charlotte Hematology Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia,
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Trident Palmetto Hematology/Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Division of Hematology/Stem Cell Transplant
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5505
Country
United States
Facility Name
Texas Oncology at Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
City
Wien
ZIP/Postal Code
1171
Country
Austria
Facility Name
ACZA, Campus Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ St. Jan, Dept of Haematology
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHU Erasme / ULB University
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Institue Jules Bordet, Unite Sterile
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Toronto General Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
McGill University Clinical Research Program
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hospital Claude Huriez
City
Lile
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hoptial Hotel Dieu
City
Paris
State/Province
Cedex
ZIP/Postal Code
75181
Country
France
Facility Name
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
City
Toulouse
State/Province
Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital de Brabois
City
Vandoeuvre
State/Province
Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hospital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Universitatsklinikum Charite Medizinische Klinik und Poliklinik
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
University of Erlangen-Nurenberg, Division of Hematology/Oncology
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Medical University Clinic (Oncology/Haematology)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Johannes-Gutenberg-University Medical School, Department of Medicine III
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Belfast City Hospital, Haematology Department
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
Ireland
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera, S. Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
City
Rotterdam
ZIP/Postal Code
3075
Country
Netherlands
Facility Name
Hospital Clinico Universitario de Barcelona, Hematologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
University Hospital of Salamanca, Hematology Dept
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Huddinge University Hospital M54, Department of Haematology
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Adult Leukaemia Unit, Christie Hospital
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Leeds General Infirmary, Department of Haematology
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Department of Haematology, ICSM
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21791470
Citation
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.
Results Reference
derived

Learn more about this trial

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

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