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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063726
• Other study ID #: M34101-040
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2003
• Last updated: January 12, 2012
• Start date: April 2002
• Est. completion date: July 2005

Study information

• Verified date: January 2012
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00049478

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• bortezomib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

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