A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: A (Thalidomide + Dexamethasone)Drug: B (Placebo + Dexamethasone)
- Registration Number
- NCT00057564
- Lead Sponsor
- Celgene Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (Thalidomide & Dexamethasone) A (Thalidomide + Dexamethasone) Thalidomide 50mg/day + Dexamethasone 40mg B (Dexamethasone and placebo) B (Placebo + Dexamethasone) Dexamethasone and placebo
- Primary Outcome Measures
Name Time Method Time to tumor progression (TTP) Up to 3 years Time to tumor progression (TTP)
- Secondary Outcome Measures
Name Time Method Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) Up to 3 years Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Myeloma response rate Up to 3 years Myeloma response determination criteria developed by Bladé et al 1998
Number of patients who survived Up to 3 years Number of patients who survived
Number of participants with adverse events Up to 3 years Number of participants with adverse events
Trial Locations
- Locations (98)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
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
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
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
East Tennessee Oncology/Hematology Associates
🇺🇸Knoxville, Tennessee, United States
Royal Brisbane Hospital
🇦🇺Herston, Queensland, Australia
Haematology Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
UMHAT Alexandrovska
🇧🇬Alexandrovska, Bulgaria
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
🇩🇪Dusseldorf, Germany
St. Laszlo Hoszpital
🇭🇺Budapest, Hungary
Hadassah University Hospital Hematology Dep't
🇮🇱Ein 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 Hashomer, 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
Clinica Ematologica Policlinico Universitario
🇮🇹Udine, Italy
Ospedale Niguarda Ca Granda
🇮🇹Milano, Italy
Policlinico San Matteo
🇮🇹Pavia, Italy
Institute of Internal Diseases University of Medicine
🇵🇱Gdansk, Poland
Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
🇮🇹Roma, Italy
Medical Academy of Bialystok
🇵🇱Bialystok, Poland
Medical University of Lodz
🇵🇱Lodz, Poland
Chelyabinsk Regional Clinical Hospital Hematology Dpt
🇷🇺Chelyabinsk, Russian Federation
Burdenko Central Military Clinical Hospital Hematology Center
🇷🇺Moscow, Russian Federation
Nizhny Novgorod Clinical Hospital
🇷🇺Novgorod, Russian Federation
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 Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
🇺🇦Dnepropetrovsk, Ukraine
Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
🇺🇦Ivano-Frankovsk, Ukraine
Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
🇺🇦Kharkov, Ukraine
Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
🇺🇦Kiev, Ukraine
Belfast City Hospital Haematology Dpt.
🇬🇧Belfast, United Kingdom
Guys Hospital
🇬🇧London, United Kingdom
South Carolina Oncology Group
🇺🇸West Columbia, South Carolina, United States
The Family Centre, PLLC
🇺🇸Collierville, Tennessee, United States
Hackensack University Hospital
🇺🇸Hackensack, New Jersey, United States
Peter MacCallum Cancer Institute
🇦🇺Melbourne, Victoria, Australia
Institut Jules Bordet Dep't of Clinical Haematology
🇧🇪Brussels, Belgium
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
🇦🇺Parkville, Victoria, Australia
Dept. Of Haematology Academisch Ziekenhuis VUB
🇧🇪Brussels, Belgium
University Hospital Ghent Dep't of Haematology
🇧🇪Ghent, Belgium
National Center of Haematology and Transfusiology
🇧🇬Sofia, Bulgaria
Military Medical Academy
🇧🇬Sofia, Bulgaria
Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Petz Aladar County Hospital
🇭🇺Gyor, Hungary
Hope Directorate Dep't. Haematology St. James's Hospital
🇮🇪Dublin, Ireland
Saskatoon Cancer Centre University of Saskatoon
🇨🇦Saskatoon, Saskatchewan, Canada
Jagiellonian University Collegium Medicum Department of Hematology
🇵🇱Krakow, 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
Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
🇷🇺Ekaterinburg, Russian Federation
Republican Clinical Hospital #1 Hematology Dpt.
🇷🇺Izhevsk, Russian Federation
Novosibirsk State Regional Clinical Hospital Hematology Centre
🇷🇺Novosibirsk, Russian Federation
Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
🇷🇺Samara, Russian Federation
Russian Academy of Medical Sciences Scientific Center of Hematology
🇷🇺Moscow, Russian Federation
Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
🇷🇺Shosse, Russian Federation
Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
🇷🇺St. Petersburg, Russian Federation
St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
🇷🇺St. Petersburg, Russian Federation
Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
🇷🇺St. Petersburg, Russian Federation
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Cherkassy Regional Oncology Center
🇺🇦Cherkassy, 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
Odessa Regional Clinical Hospital Hematology Dep't
🇺🇦Odessa, Ukraine
Zaporozhje Regional Clinical Hospital Hematology Dpt
🇺🇦Zaporozhye, Ukraine
Zhitomir Regional Clinical Hospital Hematology Centre
🇺🇦Zhitomir, Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
🇺🇦Lvov, Ukraine
MidWestern Regional Hospital Haematology Dpt.
🇮🇪Dooradoyle, Limerick, Ireland
Jackson Memorial Hospital and Clinics
🇺🇸Miami, Florida, United States
University of Miami Miller School/Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Oncology Hematology Group of South Florida
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Cleveland Clinic- Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States