A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma
1 other identifier
interventional
470
16 countries
99
Brief Summary
To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Feb 2003
Longer than P75 for phase_3 multiple-myeloma
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 4, 2003
CompletedFirst Posted
Study publicly available on registry
April 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 11, 2015
September 1, 2015
3.2 years
April 4, 2003
September 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to tumor progression (TTP)
Time to tumor progression (TTP)
Up to 3 years
Secondary Outcomes (4)
Number of patients who survived
Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Up to 3 years
Myeloma response rate
Up to 3 years
Number of participants with adverse events
Up to 3 years
Study Arms (2)
A (Thalidomide & Dexamethasone)
EXPERIMENTALThalidomide 50mg/day + Dexamethasone 40mg
B (Dexamethasone and placebo)
PLACEBO COMPARATORDexamethasone and placebo
Interventions
Thalidomide 50mg/day + Dexamethasone 40mg
Placebo + Dexamethasone 40mg
Eligibility Criteria
You may qualify if:
- Active Multiple Myeloma Stage II or III Durie Salmon
- 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
You may not qualify if:
- Pregnant or lactating females
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216, United States
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
James Berenson
West Hollywood, California, 90069, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Melbourne Internal Medicine Associates Oncology
Melbourne, Florida, 32901-3182, United States
Jackson Memorial Hospital and Clinics
Miami, Florida, 33136, United States
University of Miami Miller School/Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Oncology Hematology Group of South Florida
Miami, Florida, 33176, United States
Medical College of Georgia
Augusta, Georgia, 30912-3125, United States
Southern Illinois Hematology /Oncology
Centralia, Illinois, 62801, United States
Rush Cancer Institute Section of Hematology
Chicago, Illinois, 60612-3824, United States
University of Iowa Hospital of Clinic
Iowa City, Iowa, 52242, United States
Ocshner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0922, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Hackensack University Hospital
Hackensack, New Jersey, 07601, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1023, United States
Cleveland Clinic- Taussig Cancer Center
Cleveland, Ohio, 44195, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
South Carolina Oncology Group
West Columbia, South Carolina, 29169, United States
The Family Centre, PLLC
Collierville, Tennessee, 38017, United States
East Tennessee Oncology/Hematology Associates
Knoxville, Tennessee, 37920, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Haematology Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
Parkville, Victoria, 3050, Australia
Institut Jules Bordet Dep't of Clinical Haematology
Brussels, 1000, Belgium
Dept. Of Haematology Academisch Ziekenhuis VUB
Brussels, 1090, Belgium
University Hospital Ghent Dep't of Haematology
Ghent, 900, Belgium
UMHAT Alexandrovska
Alexandrovska, Bulgaria
National Center of Haematology and Transfusiology
Sofia, 1756, Bulgaria
Military Medical Academy
Sofia, Bulgaria
Dalhousie University
Halifax, Nova Scotia, B3H2Y9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
University Health Network Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
McGill University
Montreal, Quebec, PQ H2W 1S6, Canada
Saskatoon Cancer Centre University of Saskatoon
Saskatoon, Saskatchewan, S7N 4H4, Canada
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, Germany
St. Laszlo Hoszpital
Budapest, Hungary
Petz Aladar County Hospital
Győr, 9002, Hungary
MidWestern Regional Hospital Haematology Dpt.
Dooradoyle, Limerick, Ireland
Hope Directorate Dep't. Haematology St. James's Hospital
Dublin, 8, Ireland
Hadassah University Hospital Hematology Dep't
‘En Kerem, Jerusalem, 91120, Israel
Rambam Medical Center Dep't. Of Hematology
Haifa, 31096, Israel
Tel Aviv Sourasky Medical Center Hematology Institute
Tel Aviv, 64239, Israel
Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
Bari, 11, Italy
Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
Bologna, 40138, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
Ospedale Niguarda Ca Granda
Milan, 20162, Italy
Policlinico San Matteo
Pavia, 27100, Italy
Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
Roma, 00161, Italy
Clinica Ematologica Policlinico Universitario
Udine, 33100, Italy
Medical Academy of Bialystok
Bialystok, 15-276, Poland
Institute of Internal Diseases University of Medicine
Gdansk, 80-211, Poland
Jagiellonian University Collegium Medicum Department of Hematology
Krakow, 31-501, Poland
Medical University of Lodz
Lodz, 93-509, Poland
Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
Lublin, 20-022, Poland
Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
Warsaw, 02-097, Poland
Chelyabinsk Regional Clinical Hospital Hematology Dpt
Chelyabinsk, 454076, Russia
Republican Clinical Hospital #1 Hematology Dpt.
Izhevsk, 426039, Russia
Burdenko Central Military Clinical Hospital Hematology Center
Moscow, 105229, Russia
Russian Academy of Medical Sciences Scientific Center of Hematology
Moscow, 125167, Russia
Novosibirsk State Regional Clinical Hospital Hematology Centre
Novosibirsk, 630087, Russia
Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
Saint Petersburg, 193024, Russia
St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
Saint Petersburg, 197022, Russia
Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
Saint Petersburg, 197110, Russia
Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
Samara, 443095, Russia
Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
Shosse, 115478, Russia
Nizhny Novgorod Clinical Hospital
Veliky Novgorod, 603126, Russia
Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
Yekaterinburg, 620102, Russia
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario de la Princessa
Madrid, 28006, Spain
Hospital Doce de Octubre
Madrid, 28041, Spain
Clinica Universitaria de Navarra
Pamplona, 31080, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Universitatsspital Zurich
Zurich, 8091, Switzerland
Cherkassy Regional Oncology Center
Cherkassy, 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
Dnipro, 49044, Ukraine
Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
Ivano-Frankivsk, 76000, Ukraine
Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
Kharkiv, 61070, Ukraine
Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
Kiev, 03022, Ukraine
Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
Kiev, 03115, Ukraine
Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
Kiev, 04060, Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lviv, 79044, Ukraine
Odessa Regional Clinical Hospital Hematology Dep't
Odesa, 65025, Ukraine
Zaporozhje Regional Clinical Hospital Hematology Dpt
Zaporizhzhya, 69600, Ukraine
Zhitomir Regional Clinical Hospital Hematology Centre
Zhytomyr, 10002, Ukraine
Belfast City Hospital Haematology Dpt.
Belfast, BT9 7AB, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Guys Hospital
London, SE19RT, United Kingdom
Related Publications (1)
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.
PMID: 18362366RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2003
First Posted
April 7, 2003
Study Start
February 1, 2003
Primary Completion
April 1, 2006
Study Completion
August 1, 2013
Last Updated
September 11, 2015
Record last verified: 2015-09