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A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
A (Thalidomide + Dexamethasone)
B (Placebo + Dexamethasone)
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Newly Diagnosed Multiple Myeloma, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Clinical Research Consultants, Inc.
  • Arizona Clinical Research Center
  • UCLA School of Medicine
  • James Berenson
  • Mayo Clinic
  • Melbourne Internal Medicine Associates Oncology
  • Jackson Memorial Hospital and Clinics
  • University of Miami Miller School/Jackson Memorial Hospital
  • University of Miami
  • Oncology Hematology Group of South Florida
  • Medical College of Georgia
  • Southern Illinois Hematology /Oncology
  • Rush Cancer Institute Section of Hematology
  • University of Iowa Hospital of Clinic
  • Ocshner Clinic Foundation
  • University of Michigan Comprehensive Cancer Center
  • Mayo Clinic Cancer Center
  • Hackensack University Hospital
  • SUNY Upstate Medical University
  • Wake Forest University School of Medicine
  • Cleveland Clinic- Taussig Cancer Center
  • University of Pittsburgh
  • South Carolina Oncology Group
  • The Family Centre, PLLC
  • East Tennessee Oncology/Hematology Associates
  • Medical College of Wisconsin
  • Royal Brisbane Hospital
  • Haematology Princess Alexandra Hospital
  • Frankston Hospital
  • Peter MacCallum Cancer Institute
  • The Alfred Hospital
  • Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
  • Institut Jules Bordet Dep't of Clinical Haematology
  • Dept. Of Haematology Academisch Ziekenhuis VUB
  • University Hospital Ghent Dep't of Haematology
  • UMHAT Alexandrovska
  • National Center of Haematology and Transfusiology
  • Military Medical Academy
  • Dalhousie University
  • Princess Margaret Hospital
  • University Health Network Princess Margaret Hospital
  • Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
  • McGill University
  • Saskatoon Cancer Centre University of Saskatoon
  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
  • St. Laszlo Hoszpital
  • Petz Aladar County Hospital
  • MidWestern Regional Hospital Haematology Dpt.
  • Hope Directorate Dep't. Haematology St. James's Hospital
  • Hadassah University Hospital Hematology Dep't
  • Rambam Medical Center Dep't. Of Hematology
  • Tel Aviv Sourasky Medical Center Hematology Institute
  • Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
  • Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
  • Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
  • Azienda Ospedaliera San Martino
  • Ospedale Niguarda Ca Granda
  • Policlinico San Matteo
  • Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
  • Clinica Ematologica Policlinico Universitario
  • Medical Academy of Bialystok
  • Institute of Internal Diseases University of Medicine
  • Jagiellonian University Collegium Medicum Department of Hematology
  • Medical University of Lodz
  • Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
  • Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
  • Chelyabinsk Regional Clinical Hospital Hematology Dpt
  • Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
  • Republican Clinical Hospital #1 Hematology Dpt.
  • Burdenko Central Military Clinical Hospital Hematology Center
  • Russian Academy of Medical Sciences Scientific Center of Hematology
  • Nizhny Novgorod Clinical Hospital
  • Novosibirsk State Regional Clinical Hospital Hematology Centre
  • Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
  • Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
  • Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
  • St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
  • Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
  • Hospital Clinic
  • Hospital Universitario de la Princessa
  • Hospital Doce de Octubre
  • Clinica Universitaria de Navarra
  • Hospital Universitario de Salamanca
  • Hospital Universitario Marques de Valdecilla
  • Universitatsspital Zurich
  • Cherkassy Regional Oncology Center
  • Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
  • Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
  • Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
  • Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
  • Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
  • Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
  • Institute of Blood Pathology and Transfusion Medicine of the UAMS
  • Odessa Regional Clinical Hospital Hematology Dep't
  • Zaporozhje Regional Clinical Hospital Hematology Dpt
  • Zhitomir Regional Clinical Hospital Hematology Centre
  • Belfast City Hospital Haematology Dpt.
  • Guys Hospital
  • Guys Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A (Thalidomide & Dexamethasone)

B (Dexamethasone and placebo)

Arm Description

Thalidomide 50mg/day + Dexamethasone 40mg

Dexamethasone and placebo

Outcomes

Primary Outcome Measures

Time to tumor progression (TTP)
Time to tumor progression (TTP)

Secondary Outcome Measures

Number of patients who survived
Number of patients who survived
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Myeloma response rate
Myeloma response determination criteria developed by Bladé et al 1998
Number of participants with adverse events
Number of participants with adverse events

Full Information

First Posted
April 4, 2003
Last Updated
September 9, 2015
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00057564
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Newly Diagnosed Multiple Myeloma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A (Thalidomide & Dexamethasone)
Arm Type
Experimental
Arm Description
Thalidomide 50mg/day + Dexamethasone 40mg
Arm Title
B (Dexamethasone and placebo)
Arm Type
Placebo Comparator
Arm Description
Dexamethasone and placebo
Intervention Type
Drug
Intervention Name(s)
A (Thalidomide + Dexamethasone)
Other Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide 50mg/day + Dexamethasone 40mg
Intervention Type
Drug
Intervention Name(s)
B (Placebo + Dexamethasone)
Other Intervention Name(s)
Dexamethasone, placebo
Intervention Description
Placebo + Dexamethasone 40mg
Primary Outcome Measure Information:
Title
Time to tumor progression (TTP)
Description
Time to tumor progression (TTP)
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Number of patients who survived
Description
Number of patients who survived
Time Frame
Up to 3 years
Title
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Description
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Time Frame
Up to 3 years
Title
Myeloma response rate
Description
Myeloma response determination criteria developed by Bladé et al 1998
Time Frame
Up to 3 years
Title
Number of participants with adverse events
Description
Number of participants with adverse events
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Consultants, Inc.
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
James Berenson
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Melbourne Internal Medicine Associates Oncology
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901-3182
Country
United States
Facility Name
Jackson Memorial Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Miller School/Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Oncology Hematology Group of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3125
Country
United States
Facility Name
Southern Illinois Hematology /Oncology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Rush Cancer Institute Section of Hematology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3824
Country
United States
Facility Name
University of Iowa Hospital of Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ocshner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0922
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hackensack University Hospital
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1023
Country
United States
Facility Name
Cleveland Clinic- Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
South Carolina Oncology Group
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
The Family Centre, PLLC
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
East Tennessee Oncology/Hematology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Haematology Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Institut Jules Bordet Dep't of Clinical Haematology
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Dept. Of Haematology Academisch Ziekenhuis VUB
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Hospital Ghent Dep't of Haematology
City
Ghent
ZIP/Postal Code
900
Country
Belgium
Facility Name
UMHAT Alexandrovska
City
Alexandrovska
Country
Bulgaria
Facility Name
National Center of Haematology and Transfusiology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
University Health Network Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
PQ H2W 1S6
Country
Canada
Facility Name
Saskatoon Cancer Centre University of Saskatoon
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
City
Dusseldorf
Country
Germany
Facility Name
St. Laszlo Hoszpital
City
Budapest
Country
Hungary
Facility Name
Petz Aladar County Hospital
City
Gyor
ZIP/Postal Code
9002
Country
Hungary
Facility Name
MidWestern Regional Hospital Haematology Dpt.
City
Dooradoyle
State/Province
Limerick
Country
Ireland
Facility Name
Hope Directorate Dep't. Haematology St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Hadassah University Hospital Hematology Dep't
City
Ein Kerem
State/Province
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rambam Medical Center Dep't. Of Hematology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Hematology Institute
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico
City
Bari
ZIP/Postal Code
11
Country
Italy
Facility Name
Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Clinica Ematologica Policlinico Universitario
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Medical Academy of Bialystok
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Institute of Internal Diseases University of Medicine
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Jagiellonian University Collegium Medicum Department of Hematology
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
Facility Name
Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Chelyabinsk Regional Clinical Hospital Hematology Dpt
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Republican Clinical Hospital #1 Hematology Dpt.
City
Izhevsk
ZIP/Postal Code
426039
Country
Russian Federation
Facility Name
Burdenko Central Military Clinical Hospital Hematology Center
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences Scientific Center of Hematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Nizhny Novgorod Clinical Hospital
City
Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital Hematology Centre
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy
City
Shosse
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit
City
St. Petersburg
ZIP/Postal Code
193024
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de la Princessa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31080
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Cherkassy Regional Oncology Center
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre
City
Dnepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department
City
Ivano-Frankovsk
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kiev Institute of Oncology of the UAMS Systemic Malignancies Department
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group
City
Kiev
ZIP/Postal Code
04060
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine of the UAMS
City
Lvov
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Odessa Regional Clinical Hospital Hematology Dep't
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Zaporozhje Regional Clinical Hospital Hematology Dpt
City
Zaporozhye
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Zhitomir Regional Clinical Hospital Hematology Centre
City
Zhitomir
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Belfast City Hospital Haematology Dpt.
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18362366
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.
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A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

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