A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
NCT ID: NCT00057564
Last Updated: 2015-09-11
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
470 participants
INTERVENTIONAL
2003-02-28
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A (Thalidomide & Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
B (Dexamethasone and placebo)
Dexamethasone and placebo
B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Interventions
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A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
* Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
* Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
Exclusion Criteria
* Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
* Prior history of malignancy unless subject has been free of disease for ≥ 3 years
* Lab abnormality: Absolute neutrophil count (ANC) \<1,000 cells/mm\^3 (1.0 x 10\^9/L)
* Lab abnormality: Platelet count \<50,000/mm\^3 (50.0 x 10\^9/L)
* Lab abnormality: Serum creatinine \>3.0 mg/dL (265 µmol/L)
* Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) \>3.0 x upper limit of normal (ULN)
* Lab abnormality: Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Knight, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Clinical Research Consultants, Inc.
Hoover, Alabama, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
James Berenson
West Hollywood, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Melbourne Internal Medicine Associates Oncology
Melbourne, Florida, United States
Jackson Memorial Hospital and Clinics
Miami, Florida, United States
University of Miami Miller School/Jackson Memorial Hospital
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Oncology Hematology Group of South Florida
Miami, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Southern Illinois Hematology /Oncology
Centralia, Illinois, United States
Rush Cancer Institute Section of Hematology
Chicago, Illinois, United States
University of Iowa Hospital of Clinic
Iowa City, Iowa, United States
Ocshner Clinic Foundation
New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Hackensack University Hospital
Hackensack, New Jersey, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Cleveland Clinic- Taussig Cancer Center
Cleveland, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
South Carolina Oncology Group
West Columbia, South Carolina, United States
The Family Centre, PLLC
Collierville, Tennessee, United States
East Tennessee Oncology/Hematology Associates
Knoxville, Tennessee, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Brisbane Hospital
Herston, Queensland, Australia
Haematology Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Frankston Hospital
Frankston, Victoria, Australia
Peter MacCallum Cancer Institute
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
Parkville, Victoria, Australia
Institut Jules Bordet Dep't of Clinical Haematology
Brussels, , Belgium
Dept. Of Haematology Academisch Ziekenhuis VUB
Brussels, , Belgium
University Hospital Ghent Dep't of Haematology
Ghent, , Belgium
UMHAT Alexandrovska
Alexandrovska, , Bulgaria
National Center of Haematology and Transfusiology
Sofia, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
Dalhousie University
Halifax, Nova Scotia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada
Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
Fleurimont, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Saskatoon Cancer Centre University of Saskatoon
Saskatoon, Saskatchewan, Canada
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, , Germany
St. Laszlo Hoszpital
Budapest, , Hungary
Petz Aladar County Hospital
Győr, , Hungary
MidWestern Regional Hospital Haematology Dpt.
Dooradoyle, Limerick, Ireland
Hope Directorate Dep't. Haematology St. James's Hospital
Dublin, , Ireland
Hadassah University Hospital Hematology Dep't
‘En Kerem, Jerusalem, Israel
Rambam Medical Center Dep't. Of Hematology
Haifa, , Israel
Tel Aviv Sourasky Medical Center Hematology Institute
Tel Aviv, , Israel
Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
Bari, , Italy
Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
Bologna, , Italy
Azienda Ospedaliera San Martino
Genova, , Italy
Ospedale Niguarda Ca Granda
Milan, , Italy
Policlinico San Matteo
Pavia, , Italy
Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
Roma, , Italy
Clinica Ematologica Policlinico Universitario
Udine, , Italy
Medical Academy of Bialystok
Bialystok, , Poland
Institute of Internal Diseases University of Medicine
Gdansk, , Poland
Jagiellonian University Collegium Medicum Department of Hematology
Krakow, , Poland
Medical University of Lodz
Lodz, , Poland
Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
Lublin, , Poland
Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
Warsaw, , Poland
Chelyabinsk Regional Clinical Hospital Hematology Dpt
Chelyabinsk, , Russia
Republican Clinical Hospital #1 Hematology Dpt.
Izhevsk, , Russia
Burdenko Central Military Clinical Hospital Hematology Center
Moscow, , Russia
Russian Academy of Medical Sciences Scientific Center of Hematology
Moscow, , Russia
Novosibirsk State Regional Clinical Hospital Hematology Centre
Novosibirsk, , Russia
Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
Saint Petersburg, , Russia
Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
Saint Petersburg, , Russia
Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
Samara, , Russia
Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
Shosse, , Russia
Nizhny Novgorod Clinical Hospital
Veliky Novgorod, , Russia
Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
Yekaterinburg, , Russia
Hospital Clinic
Barcelona, , Spain
Hospital Universitario de la Princessa
Madrid, , Spain
Hospital Doce de Octubre
Madrid, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Universitatsspital Zurich
Zurich, , Switzerland
Cherkassy Regional Oncology Center
Cherkassy, , Ukraine
Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
Dnipro, , Ukraine
Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
Ivano-Frankivsk, , Ukraine
Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
Kharkiv, , Ukraine
Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
Kiev, , Ukraine
Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
Kiev, , Ukraine
Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
Kiev, , Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lviv, , Ukraine
Odessa Regional Clinical Hospital Hematology Dep't
Odesa, , Ukraine
Zaporozhje Regional Clinical Hospital Hematology Dpt
Zaporizhzhya, , Ukraine
Zhitomir Regional Clinical Hospital Hematology Centre
Zhytomyr, , Ukraine
Belfast City Hospital Haematology Dpt.
Belfast, , United Kingdom
Guys Hospital
London, , United Kingdom
Guys Hospital
London, , United Kingdom
Countries
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References
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Rajkumar SV, Rosinol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Blade J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. doi: 10.1200/JCO.2007.14.1853. Epub 2008 Mar 24.
Other Identifiers
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THAL-MM-003
Identifier Type: -
Identifier Source: org_study_id
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