Clinical trial NCT00057564: A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2003-04-08
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Time to tumor progression (TTP)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of patients who survived
timeFrame: Up to 3 years
measure: Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
timeFrame: Up to 3 years
measure: Myeloma response rate
timeFrame: Up to 3 years
measure: Number of participants with adverse events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants, Inc.
state: Alabama
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: West Hollywood
country: United States
facility: James Berenson
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates Oncology
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital and Clinics
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School/Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Oncology Hematology Group of South Florida
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Centralia
country: United States
facility: Southern Illinois Hematology /Oncology
state: Illinois
city: Chicago
country: United States
facility: Rush Cancer Institute Section of Hematology
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital of Clinic
state: Iowa
city: New Orleans
country: United States
facility: Ocshner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Hospital
state: New Jersey
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic- Taussig Cancer Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: West Columbia
country: United States
facility: South Carolina Oncology Group
state: South Carolina
city: Collierville
country: United States
facility: The Family Centre, PLLC
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Oncology/Hematology Associates
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Haematology Princess Alexandra Hospital
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
state: Victoria
city: Brussels
country: Belgium
facility: Institut Jules Bordet Dep't of Clinical Haematology
city: Brussels
country: Belgium
facility: Dept. Of Haematology Academisch Ziekenhuis VUB
city: Ghent
country: Belgium
facility: University Hospital Ghent Dep't of Haematology
city: Alexandrovska
country: Bulgaria
facility: UMHAT Alexandrovska
city: Sofia
country: Bulgaria
facility: National Center of Haematology and Transfusiology
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre University of Saskatoon
state: Saskatchewan
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
city: Budapest
country: Hungary
facility: St. Laszlo Hoszpital
city: Gyor
country: Hungary
facility: Petz Aladar County Hospital
city: Dooradoyle
country: Ireland
facility: MidWestern Regional Hospital Haematology Dpt.
state: Limerick
city: Dublin
country: Ireland
facility: Hope Directorate Dep't. Haematology St. James's Hospital
city: Ein Kerem
country: Israel
facility: Hadassah University Hospital Hematology Dep't
state: Jerusalem
city: Haifa
country: Israel
facility: Rambam Medical Center Dep't. Of Hematology
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Hematology Institute
city: Tel Hashomer
country: Israel
facility: Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
city: Bari
country: Italy
facility: Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
city: Udine
country: Italy
facility: Clinica Ematologica Policlinico Universitario
city: Bialystok
country: Poland
facility: Medical Academy of Bialystok
city: Gdansk
country: Poland
facility: Institute of Internal Diseases University of Medicine
city: Krakow
country: Poland
facility: Jagiellonian University Collegium Medicum Department of Hematology
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Lublin
country: Poland
facility: Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
city: Warsaw
country: Poland
facility: Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital Hematology Dpt
city: Ekaterinburg
country: Russian Federation
facility: Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
city: Izhevsk
country: Russian Federation
facility: Republican Clinical Hospital #1 Hematology Dpt.
city: Moscow
country: Russian Federation
facility: Burdenko Central Military Clinical Hospital Hematology Center
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences Scientific Center of Hematology
city: Novgorod
country: Russian Federation
facility: Nizhny Novgorod Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital Hematology Centre
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
city: Shosse
country: Russian Federation
facility: Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
city: St. Petersburg
country: Russian Federation
facility: Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncology Center
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
city: Ivano-Frankovsk
country: Ukraine
facility: Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
city: Kharkov
country: Ukraine
facility: Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
city: Kiev
country: Ukraine
facility: Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
city: Kiev
country: Ukraine
facility: Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
city: Kiev
country: Ukraine
facility: Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
city: Lvov
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS
city: Odessa
country: Ukraine
facility: Odessa Regional Clinical Hospital Hematology Dep't
city: Zaporozhye
country: Ukraine
facility: Zaporozhje Regional Clinical Hospital Hematology Dpt
city: Zhitomir
country: Ukraine
facility: Zhitomir Regional Clinical Hospital Hematology Centre
city: Belfast
country: United Kingdom
facility: Belfast City Hospital Haematology Dpt.
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: Guys Hospital
Study officials:
affiliation: Celgene Corporation
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
citation: 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.