PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT00048230
Last Updated: 2012-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
620 participants
INTERVENTIONAL
2002-06-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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bortezomib
Eligibility Criteria
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Inclusion Criteria
* 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* Male patient agrees to use an acceptable method for contraception for the duration of the study.
* Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second-, third-, or fourth-line therapy because of PD, defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium \>11.5 mg/dL), or relapse from CR.
* Patient has measurable disease, defined as follows:
* For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, greater than 1 g/dL of IgG M-Protein and greater than 0.5g/dL IgA) and, where applicable, urine light-chain excretion of ≥200 mg/24 hours.
* For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessments. Therefore, other disease sites (bone marrow; extramedullary mass) must be assessed and followed. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation.
* Patient has a Karnofsky performance status ≥60%.
* Patient has a life-expectancy \>3 months.
* Patient has the following laboratory values at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration):
* Platelet count ≥50 x 10E+9/L without transfusion support within 7 days before the laboratory test.
* Hemoglobin ≥7.5 g/dL, without transfusion support within 7 days before the laboratory test.
* Absolute neutrophil count (ANC) ≥0.75 x 10E+9/L without the use of colony stimulating factors.
* Corrected 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.
* Calculated or measured creatinine clearance: ≥20 mL/minute.
Exclusion Criteria
* Patient previously was refractory to treatment with high-dose dexamethasone, as experiencing less than a partial response to or PD within 6 months after discontinuing dexamethasone, or discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity.
* Previous high-dose dexamethasone therapy is defined as \>500 mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen.
* Patient received nitrosoureas within 6 weeks or any other chemotherapy, including thalidomide or clarithromycin, or radiation therapy within 3 weeks before enrollment.
* Patient received corticosteroids (\>10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
* Patient received immunotherapy or antibody therapy within 8 weeks before enrollment.
* Patient received plasmapheresis within 4 weeks before enrollment.
* Patient had major surgery within 4 weeks before enrollment. (Kyphoplasty is not considered major surgery.)
* Patient has a history of allergic reaction attributable to compounds containing boron or mannitol.
* Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC):
* Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs).
* Grade 3: Sensory loss or paresthesia interfering with ADLs.
* Grade 4: Permanent sensory loss that interferes with function.
* Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Patient was treated for a cancer other than multiple myeloma within 5 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.
* Patient has cardiac amyloidosis.
* Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
* 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.
* Patient has an active systemic infection requiring treatment.
* Female patient is pregnant or breast-feeding.
* Patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
City of Hope
Duarte, California, United States
Scripps Clinic
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente Oncology Clinical Trials
Vallejo, California, United States
Lombardi Cancer Center, Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Med Star Institute, Washington Cancer Center
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, University of S. Florida
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
Shreveport, Louisiana, United States
Tufts New England Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Kirstein Room 135
Boston, Massachusetts, United States
Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center
Ann Arbor, Michigan, United States
VA Medical Center, Sections of Hematology/Oncology
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, Division of Hematology/Oncology
New Hyde Park, New York, United States
St. Vincent's Comprehensive Cancer Center, Research Department
New York, New York, United States
NY Presbyterian Hospital
New York, New York, United States
Rochester General Hospital, Lipson Cancer Blood Center
Rochester, New York, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, United States
Carolinas 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, Dept. of Human Oncology
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
Baylor Institute for Immunology Research
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
Institut Jules Bordet, Unite Sterile
Brussels, , Belgium
CHU Erasme / ULB University, Hematology 7th Floor
Brussels, , Belgium
C.H. Notre Dame-Reine Fabiola
Charleroi, , Belgium
UZ Gasthuisberg, Department of Hematology
Leuven, , Belgium
AZ St. Jan, Dept. of Haematology
Rugge, , Belgium
Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour
Yvoir, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
London Health Sciences Center
London, Ontario, Canada
Toronto General Research Institute, Princess Margaret Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hospital Claude Huriez, Service des Maladies du Sang
Lille, Cedex, France
Nantes Hotel Dieu Hospital
Nantes, Cedex, France
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
Toulouse, Cedex, France
Institut Gustave-Roussy, Service d'Hematologie
Villejuif, Cedex, France
Hopital Antoine Beclere, Hopital de Jour de Medecine Interne
Clamart, , France
Hopital Hotel Dieu, Service d'hematologie et oncologie medicale
Paris, , France
Hopital Saint-Louis, Direction Financiere
Paris, , France
Hopital Cochin, Service de Hematologie
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital de Brabois, Service Hematologie et Medecine Interne
Vandœuvre-lès-Nancy, , France
Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie
Berlin, , Germany
Medizinische Klinik und Poliklinik 1
Bonn, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
University of Erlangen-Nurenberg, Division of Hematology/Oncology
Erlangen, , Germany
Freiburg University Medical Center, Dept. of Hemayology/Oncology
Freiburg im Breisgau, , Germany
Medical University Clinic (Oncology/Haematology)
Hamburg, , Germany
St. Marien Hospital, Klinik fur Hamatologie und Onkologie
Hamm, , Germany
Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie
Heidelberg, , Germany
University of Essen Medical School, Dept. of Internal Medicine
Hufelandstr, , Germany
Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik
Mainz, , Germany
Uniklinikum Muenster
Münster, , Germany
Eberhard-Karls Universitat, Medizinische Klinik
Tübingen, , Germany
Belfast City Hospital
Belfast, , Ireland
RAMBAM Medical Center, Department of Hematology and Bone
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Dipartmento Clinico esperimentale Di Oncologia et Ematolgia
Bergamo, , Italy
Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli
Bologna, , Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia
Roma, , Italy
Azienda Ospedaliera, S. Giovanni Battista
Torino, , Italy
Dept. of Clinical Hematology, Academic Medical Center
Amsterdam, , Netherlands
Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed
Rotterdam, , Netherlands
Dept. Hematology, University Medical Centre
Utrecht, , Netherlands
Hospital Clinico Universitario de Barcelona, Haematology Department
Barcelona, , Spain
University Hospital of Salamanca
Salamanca, , Spain
Department of Haematology, Huddinge University Hospital M54
Stockholm, , Sweden
Karolinska Hospital, Dept. of Hematology
Stockholm, , Sweden
Adult Leukaemia Unit, Christie Hospital
Withington, Manchester, United Kingdom
Department of Haematology, Queen Elizabeth Hospital
Birmingham, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Department of Haematology, St. Bartholomew's Hospital
London, , United Kingdom
Department of Haematology, ICSM, Hammersmith Hospital
London, , United Kingdom
Royal Marsden Hospital, Leukaemia and Myeloma Units
Sutton, , United Kingdom
Countries
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References
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Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.
Lichter DI, Danaee H, Pickard MD, Tayber O, Sintchak M, Shi H, Richardson PG, Cavenagh J, Blade J, Facon T, Niesvizky R, Alsina M, Dalton W, Sonneveld P, Lonial S, van de Velde H, Ricci D, Esseltine DL, Trepicchio WL, Mulligan G, Anderson KC. Sequence analysis of beta-subunit genes of the 20S proteasome in patients with relapsed multiple myeloma treated with bortezomib or dexamethasone. Blood. 2012 Nov 29;120(23):4513-6. doi: 10.1182/blood-2012-05-426924. Epub 2012 Sep 27.
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.
Vogl DT, Stadtmauer EA, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Facon T, Harousseau JL, Boral A, Neuwirth R, Anderson KC. Impact of prior therapies on the relative efficacy of bortezomib compared with dexamethasone in patients with relapsed/refractory multiple myeloma. Br J Haematol. 2009 Nov;147(4):531-4. doi: 10.1111/j.1365-2141.2009.07875.x. Epub 2009 Sep 1.
Other Identifiers
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M34101-039
Identifier Type: -
Identifier Source: org_study_id
NCT00052260
Identifier Type: -
Identifier Source: nct_alias
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