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Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma Clinical research trials and Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma. Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma



Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma

For Condition: Multiple Myeloma
Status: Recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Active Multiple Myeloma Stage II or III Durie Salmon - Measurable levels of myeloma paraprotein in serum or urine - 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 greater than or equal to grade 2 of the NCI CTC. - Prior history of malignancy unless subject has been free of disease for greater than or equal to 5 years - Lab abnormality: Absolute neutrophil count less than 1,000 cells/mm cubed - Lab abnormality: Platelet count less than 50,000 mm cubed - Lab abnormality: Serum creatinine greater than 3.0 mg/dL - Lab abnormality: Serum SGOT/AST or SGPT/ALT greater than 3 times the upper limit - Lab abnormality: Serum total bilirubin greater than 2.0 mg/dL.
Total Enrollment: 436

Location and Contact Information:

Jackson Memorial Hospital and Clinics *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Jim  Hanlon 305-243-9115

Medical Academy of Bialystok *Recruiting*
Bialystok,  ,  15-276
Poland
Recruiting Janusz  Kloczko 0048 85 7468603

Frankston Hospital *Recruiting*
Frankston,  Victoria,  3199
Australia
Recruiting John  Catalano 0661-3-9784-7198

Clinica Universitaria de Navarra *Recruiting*
Pamplona,  ,  31080
Spain
Recruiting Felipe  Prosper 0034 94 829 63 97

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0922
United States
Recruiting Joanne  Goodson 734-647-8174

Royal Brisbane Hospital *Recruiting*
HERSTON,  Queensland,  4029
Australia
Recruiting Peter  Wood 0061-413-726673

University of Iowa Hospital of Clinic *No longer recruiting*
Iowa City,  Iowa,  52242
United States
No longer recruiting  

Dalhousie University *Recruiting*
Halifax,  Nova Scotia,  B3H2Y9
Canada
Recruiting Darrell  White 902-473-4642

Policlinico San Matteo *Recruiting*
Pavia,  ,  27100
Italy
Recruiting Mario  Lazzarino 0039-0382-503596

UCLA School of Medicine *Recruiting*
Los Angeles,  California,  90095
United States
Recruiting Gary  Schiller 310-825-5513

Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli" *Recruiting*
Bologna,  ,  40138
Italy
Recruiting Michele  Baccarani 0039 051 6363680

Hospital Clinic *Recruiting*
Barcelona,  ,  08036
Spain
Recruiting Joan  Blade 0034 93 227 54 28

Southern Illinois Hematology /Oncology *Recruiting*
Centralia,  Illinois,  62801
United States
Recruiting Lynn  Ann 618-533-5000

McGill University *Recruiting*
Montreal,  Quebec,  PQ H2W 1S6
Canada
Recruiting Penny  Chipman 514-398-1444

Institute of Internal Diseases University of Medicine *Recruiting*
Gdansk,  ,  80-211
Poland
Recruiting Hanna  Ciepluch 0048 58 349 22 30

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Vivek  Roy 904-953-6136

Clinical Research Consultants, Inc. *Recruiting*
Hoover,  Alabama,  35216
United States
Recruiting Linda  Hammit 205-824-3635

University of Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15213
United States
Recruiting G.  Roodman 412-692-4438

Azienda Ospedaliera San Martino *Recruiting*
Genova,  ,  16132
Italy
Recruiting Marco  Gobbi 0039-010-3538995

Melbourne Internal Medicine Associates Oncology *No longer recruiting*
Melbourne,  Florida,  32901-3182
United States
No longer recruiting  

SUNY Upstate Medical University *No longer recruiting*
Syracuse,  New York,  13210
United States
No longer recruiting  

Clinica Ematologica Policlinico Universitario *Recruiting*
Udine,  ,  33100
Italy
Recruiting Renato  Fanin 0039 0432 559662-4

South Carolina Oncology Group *Recruiting*
West Columbia,  South Carolina,  29169
United States
Recruiting Ashley  McDougald 803-791-1444

Wake Forest University School of Medicine *Recruiting*
Winston Salem,  North Carolina,  27157-1023
United States
Recruiting Karen  Craver 336-713-4394

Ospedale Niguarda Ca Granda *Recruiting*
Milano,  ,  20162
Italy
Recruiting Enrica  Morra 0039 02 6444 2668

Medical College of Georgia *No longer recruiting*
Augusta,  Georgia,  30912-3125
United States
No longer recruiting  

Cleveland Clinic- Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Janice  Reed 216-444-0589

The Alfred Hospital *Recruiting*
Melbourne,  Victoria,  3004
Australia
Recruiting Andrew  Spencer 0061-3-9276-3392

Peter MacCallum Cancer Institute *Recruiting*
Melbourne,  Victoria,  3002
Australia
Recruiting Miles  Prince 0061-3-9656-1700

Rush Cancer Institute Section of Hematology *Recruiting*
Chicago,  Illinois,  60612-3824
United States
Recruiting Terri  O'Brien 313-942-5689

Hospital Universitario Marques de Valdecilla *Recruiting*
Santander,  ,  39008
Spain
Recruiting Aranzazu  Bermudez 0034 94 220 25 73

Universitatsspital Zurich *Recruiting*
Zurich,  ,  8091
Switzerland
Recruiting Christian  Taverna 0041-1-25-52-153

Ocshner Clinic Foundation *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Carol  Marques 504-842-3708

Oncology Hematology Group of South Florida *No longer recruiting*
Miami,  Florida,  33176
United States
No longer recruiting  

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Ann  Birgin 507-284-8828

Medical University of Lodz *Recruiting*
Lodz,  ,  93-509
Poland
Recruiting Anna  Pluzanska 0048 43 689 54 30

Hospital Universitario de la Princessa *Recruiting*
Madrid,  ,  28006
Spain
Recruiting Adrian  Alegre 0034 91 520 24 58

Hospital Universitario de Salamanca *Recruiting*
Salamanca,  ,  37007
Spain
Recruiting Jesus  Miguel 0034 92 329 13 84

Hackensack University Hospital *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Laura  McBride 201-336-8020

Medical College of Wisconsin *Recruiting*
Milwaukee,  Wisconsin,  53226
United States
Recruiting Marilyn  Cavington 414-805-4627

University of Miami *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Jim  Hanlon 305-243-9115

Guys Hospital *Recruiting*
London,  ,  SE19RT
United Kingdom
Recruiting Stephen  Schey 0044-207-955-4003

Arizona Clinical Research Center *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Maria  Gallegos 520-290-9896


Additional Information:
Study ID Numbers:
  THAL-MM-003; 
Study Start Date: February 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057564

Other Multiple Myeloma Studies:
1. A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

2. Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With Multiple Myeloma

3. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

4. A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients with Multiple Myeloma

5. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

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