Clinical trial NCT00063726: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Sciences
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: Scripps Clinic, Green Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Washington
country: United States
facility: Lombardi Cancer Center, Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Med Star Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: Hematology/Oncology Associates, PA
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago,
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center
state: Illinois
city: Sheveport
country: United States
facility: LSU HC
state: Louisiana
city: Boston
country: United States
facility: Tufts England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Univ. of Michigan Comp. Cancer Center,
state: Michigan
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center, David Jurist Research Building
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University, NY Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center, James P. Wilmot Cancer Center
state: New York
city: Charlotte
country: United States
facility: Charlotte Hematology Oncology Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia,
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Palmetto Hematology/Oncology
state: South Carolina
city: Nashville
country: United States
facility: Division of Hematology/Stem Cell Transplant
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology at Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Wien
country: Austria
facility: Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie
city: Antwerpen
country: Belgium
facility: ACZA, Campus Stuivenberg
city: Brugge
country: Belgium
facility: AZ St. Jan, Dept of Haematology
city: Brussels
country: Belgium
facility: CHU Erasme / ULB University
city: Bruxelles
country: Belgium
facility: Institue Jules Bordet, Unite Sterile
city: Charleroi
country: Belgium
facility: C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Research Institute
state: Ontario
city: Montreal
country: Canada
facility: McGill University Clinical Research Program
state: Quebec
city: Lile
country: France
facility: Hospital Claude Huriez
state: Cedex
city: Paris
country: France
facility: Hoptial Hotel Dieu
state: Cedex
city: Toulouse
country: France
facility: Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
state: Cedex
city: Vandoeuvre
country: France
facility: Hopital de Brabois
state: Cedex
city: Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Paris
country: France
facility: Hospital Saint-Louis
city: Berlin
country: Germany
facility: Universitatsklinikum Charite Medizinische Klinik und Poliklinik
city: Bonn
country: Germany
facility: Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
city: Erlangen
country: Germany
facility: University of Erlangen-Nurenberg, Division of Hematology/Oncology
city: Hamburg
country: Germany
facility: Medical University Clinic (Oncology/Haematology)
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Mainz
country: Germany
facility: Johannes-Gutenberg-University Medical School, Department of Medicine III
city: Muenster
country: Germany
facility: Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
city: Belfast
country: Ireland
facility: Belfast City Hospital, Haematology Department
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Roma
country: Italy
facility: Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
city: Torino
country: Italy
facility: Azienda Ospedaliera, S. Giovanni Battista
city: Rotterdam
country: Netherlands
facility: Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
city: Barcelona
country: Spain
facility: Hospital Clinico Universitario de Barcelona, Hematologia
city: Salamanca
country: Spain
facility: University Hospital of Salamanca, Hematology Dept
city: Stockholm
country: Sweden
facility: Huddinge University Hospital M54, Department of Haematology
city: Withington
country: United Kingdom
facility: Adult Leukaemia Unit, Christie Hospital
state: Manchester
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary, Department of Haematology
city: London
country: United Kingdom
facility: Department of Haematology, ICSM
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
References:
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.