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Multiple MyelomaPhase 3NCT00048230

PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 93 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will compare the efficacy of PS-341 versus high dose dexamethasone. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
What is being tested?
bortezomib
How many people
620 participants
Where
93 sitesin 13 countries
Study dates
Jun 2002to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient is of a legally consenting age, as defined by local regulations.
  • 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.
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  • 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.

Who cannot join

  • Patient previously received treatment with VELCADE.
  • 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.
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  • 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.

Trial locations and contacts

93 sites in 13 countries.

93 sites in 13 countries

United States39 sites

  • Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center

    Ann Arbor, Michigan, 48109-0922

  • Emory University

    Atlanta, Georgia, 30322

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Center

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center, Kirstein Room 135

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Trident Palmetto Hematology/Oncology

    Charleston, South Carolina, 29406

  • Carolinas Hematology-Oncology Associates

    Charlotte, North Carolina, 28203

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Texas Oncology at Medical City Dallas Hospital

    Dallas, Texas, 75225

  • Baylor Institute for Immunology Research

    Dallas, Texas, 75246

  • City of Hope

    Duarte, California, 91010

  • Hackensack University Medical Center, David Jurist Research Building

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Hematology/Oncology Associates, PA

    Jacksonville, Florida, 32207

  • Scripps Clinic

    La Jolla, California, 92307

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Loyola University Medical Center: Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • VA Medical Center, Sections of Hematology/Oncology

    Minneapolis, Minnesota, 55417

  • Division of Hematology/Stem Cell Transplant

    Nashville, Tennessee, 37232-5505

  • Long Island Jewish Medical Center, Division of Hematology/Oncology

    New Hyde Park, New York, 11040

  • St. Vincent's Comprehensive Cancer Center, Research Department

    New York, New York, 10011

  • NY Presbyterian Hospital

    New York, New York, 10021

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Western Pennsylvania Hospital, Dept. of Human Oncology

    Pittsburgh, Pennsylvania, 15224

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rochester General Hospital, Lipson Cancer Blood Center

    Rochester, New York, 14621

  • University of Rochester Medical Center, James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • LSU HC

    Shreveport, Louisiana, 71130

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center, University of S. Florida

    Tampa, Florida, 33612

  • Kaiser Permanente Oncology Clinical Trials

    Vallejo, California, 94589

  • Lombardi Cancer Center, Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Med Star Institute, Washington Cancer Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Germany12 sites

  • Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie

    Berlin, 10098

  • Medizinische Klinik und Poliklinik 1

    Bonn, 53127

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

  • University of Erlangen-Nurenberg, Division of Hematology/Oncology

    Erlangen, 91054

  • Freiburg University Medical Center, Dept. of Hemayology/Oncology

    Freiburg im Breisgau, 79106

  • Medical University Clinic (Oncology/Haematology)

    Hamburg, 20246

  • St. Marien Hospital, Klinik fur Hamatologie und Onkologie

    Hamm, 59071

  • Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie

    Heidelberg, 69115

  • University of Essen Medical School, Dept. of Internal Medicine

    Hufelandstr, 55 45122

  • Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik

    Mainz, 55101

  • Uniklinikum Muenster

    Münster, 48129

  • Eberhard-Karls Universitat, Medizinische Klinik

    Tübingen, 72076

Other trials in Germany

France10 sites

  • Hopital Antoine Beclere, Hopital de Jour de Medecine Interne

    Clamart, 92140

  • Hospital Claude Huriez, Service des Maladies du Sang

    Lille, Cedex, 59037

  • Nantes Hotel Dieu Hospital

    Nantes, Cedex, 01 44093

  • Hopital Hotel Dieu, Service d'hematologie et oncologie medicale

    Paris, 75004

  • Hopital Saint-Louis, Direction Financiere

    Paris, 75010

  • Hopital Cochin, Service de Hematologie

    Paris, 75014

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

    Toulouse, Cedex, 31059

  • Hopital de Brabois, Service Hematologie et Medecine Interne

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave-Roussy, Service d'Hematologie

    Villejuif, Cedex, 94805

Other trials in France

Belgium7 sites

  • ACZA, Campus Stuivenberg

    Antwerp, 2060

  • Institut Jules Bordet, Unite Sterile

    Brussels, 1000

  • CHU Erasme / ULB University, Hematology 7th Floor

    Brussels, 1070

  • C.H. Notre Dame-Reine Fabiola

    Charleroi, 6000

  • UZ Gasthuisberg, Department of Hematology

    Leuven, 3000

  • AZ St. Jan, Dept. of Haematology

    Rugge, 8000

  • Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour

    Yvoir, 5530

Other trials in Belgium

United Kingdom6 sites

  • Department of Haematology, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • Department of Haematology, St. Bartholomew's Hospital

    London, EC1A 7BE

  • Department of Haematology, ICSM, Hammersmith Hospital

    London, W12 0NN

  • Royal Marsden Hospital, Leukaemia and Myeloma Units

    Sutton, SM2 5PT

  • Adult Leukaemia Unit, Christie Hospital

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Center

    London, Ontario, N6A 4G5

  • Royal Victoria Hospital

    Montreal, Quebec, H2W 1S6

  • Toronto General Research Institute, Princess Margaret Hospital

    Toronto, Ontario, M5G2M9

Other trials in Canada

Italy4 sites

  • Dipartmento Clinico esperimentale Di Oncologia et Ematolgia

    Bergamo, 24128

  • Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli

    Bologna, 40138

  • Dipartimento di Biotecnologie Cellulari ed Ematologia

    Roma, 00161

  • Azienda Ospedaliera, S. Giovanni Battista

    Torino, 10126

Other trials in Italy

Netherlands3 sites

  • Dept. of Clinical Hematology, Academic Medical Center

    Amsterdam, 1105

  • Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed

    Rotterdam, 3075

  • Dept. Hematology, University Medical Centre

    Utrecht, 3584 CX

Other trials in Netherlands

Israel2 sites

  • RAMBAM Medical Center, Department of Hematology and Bone

    Haifa, 31096

  • Hadassah University Hospital

    Jerusalem, 91120

Other trials in Israel

Spain2 sites

  • Hospital Clinico Universitario de Barcelona, Haematology Department

    Barcelona, 08036

  • University Hospital of Salamanca

    Salamanca, 37007

Other trials in Spain

Sweden2 sites

  • Department of Haematology, Huddinge University Hospital M54

    Stockholm, 14186

  • Karolinska Hospital, Dept. of Hematology

    Stockholm, 17176

Other trials in Sweden

Austria1 site

  • Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

    Vienna, 1171

Other trials in Austria

Ireland1 site

  • Belfast City Hospital

    Belfast, BT9 7AB

Other trials in Ireland

About this study

Official title: An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

This study will compare the efficacy of PS-341 versus high dose dexamethasone.

Being tested
bortezomib
Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2002 (estimated)
  2. Study startJun 2002
  3. Primary completionJul 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00048230
Sponsor's protocol ID
M34101-039
Status last verified
Jan 2012
First submitted
28 Oct 2002
Last updated
13 Jan 2012
Results posted
No

Publications

  • 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.

    PubMed 25261096

  • 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.

    PubMed 23018640

  • 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.

    PubMed 21791470

  • 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.

    PubMed 19725827

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 93 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Germany, France, Belgium, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00048230, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.

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