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

This study is currently recruiting patients.

Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation

Purpose

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.

Condition Treatment or Intervention Phase
Multiple Myeloma
 Drug: Thalidomide
 Drug: Dexamethasone
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects with Multiple Myeloma

Further Study Details: 

Expected Total Enrollment:  436

Study start: February 2003;  Expected completion: February 2010

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Location and Contact Information


Alabama
      Clinical Research Consultants, Inc., Hoover,  Alabama,  35216,  United States; Recruiting
Linda Hammit  205-824-3635 
Luigi Bertoli, Dr.,  Principal Investigator

Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States; Recruiting
Maria Gallegos  520-290-9896 
Manuel Modiano, MD,  Principal Investigator

California
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States; Recruiting
Gary Schiller  310-825-5513 
Gary Schiller, MD,  Principal Investigator

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

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

      Mayo Clinic, Jacksonville,  Florida,  32224,  United States; Recruiting
Vivek Roy  904-953-6136 
Vivek Roy, MD,  Principal Investigator

      Jackson Memorial Hospital and Clinics, Miami,  Florida,  33136,  United States; Recruiting
Jim Hanlon  305-243-9115 
Hugo Fernandez, MD,  Principal Investigator

      University of Miami, Miami,  Florida,  33136,  United States; Recruiting
Jim Hanlon  305-243-9115 
Hugo Fernandez, MD,  Principal Investigator

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

Illinois
      Southern Illinois Hematology /Oncology, Centralia,  Illinois,  62801,  United States; Recruiting
Lynn Ann  618-533-5000 
James E Hays, Dr.,  Principal Investigator

      Rush Cancer Institute Section of Hematology, Chicago,  Illinois,  60612-3824,  United States; Recruiting
Terri O'Brien, RN  313-942-5689 
Stephanie Gregory, MD,  Principal Investigator

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

Louisiana
      Ocshner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States; Recruiting
Carol Marques, RN  504-842-3708 
David Oubre, MD,  Principal Investigator

Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0922,  United States; Recruiting
Joanne Goodson  734-647-8174 
Andrzej Jakubowiak, MD,  Principal Investigator

Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Ann Birgin  507-284-8828 
Vincent Rajkumar, MD,  Principal Investigator

New Jersey
      Hackensack University Hospital, Hackensack,  New Jersey,  07601,  United States; Recruiting
Laura McBride  201-336-8020 
David Siegel  201-996-5900 
David Siegel, MD,  Principal Investigator

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

North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157-1023,  United States; Recruiting
Karen Craver  336-713-4394 
David Hurd, MD,  Principal Investigator

Ohio
      Cleveland Clinic- Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Janice Reed  216-444-0589 
Mohammed Hussein, MD,  Principal Investigator

Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
G. David Roodman  412-692-4438 
G. David Roodman, MD,  Principal Investigator

South Carolina
      South Carolina Oncology Group, West Columbia,  South Carolina,  29169,  United States; Recruiting
Ashley McDougald, RN  803-791-1444 
Rosemary Lambert-Falls, MD,  Principal Investigator

Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Marilyn Cavington  414-805-4627 
David Vesole, MD,  Principal Investigator

Australia, Queensland
      Royal Brisbane Hospital, HERSTON,  Queensland,  4029,  Australia; Recruiting
Peter Wood  0061-413-726673    Peter_Wood@health.qld.gov.au 
Peter Wood, MD,  Principal Investigator

Australia, Victoria
      Frankston Hospital, Frankston,  Victoria,  3199,  Australia; Recruiting
John Catalano  0661-3-9784-7198    john.catalano@med.monash.edu.au 
John Catalano, MD,  Principal Investigator

      Peter MacCallum Cancer Institute, Melbourne,  Victoria,  3002,  Australia; Recruiting
Miles Prince  0061-3-9656-1700    mprince@petermac.unimelb.edu 
Miles Prince, MD,  Principal Investigator

      The Alfred Hospital, Melbourne,  Victoria,  3004,  Australia; Recruiting
Andrew Spencer  0061-3-9276-3392    aspencer@netspace.net.au 
Andrew Spencer, MD,  Principal Investigator

Canada, Nova Scotia
      Dalhousie University, Halifax,  Nova Scotia,  B3H2Y9,  Canada; Recruiting
Darrell White  902-473-4642 
Darrell White, MD,  Principal Investigator

Canada, Quebec
      McGill University, Montreal,  Quebec,  PQ H2W 1S6,  Canada; Recruiting
Penny Chipman  514-398-1444 
Barbara Adanska  514-842-1231  Ext. 35033 
Chaim Shustik, MD,  Principal Investigator

Italy
      Clinica Ematologica Policlinico Universitario, Udine,  33100,  Italy; Recruiting
Renato Fanin  0039 0432 559662-4 
Renato Fanin, Prof,  Principal Investigator

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

      Ospedale Niguarda Ca Granda, Milano,  20162,  Italy; Recruiting
Enrica Morra  0039 02 6444 2668 
Enrica Morra, MD,  Principal Investigator

      Azienda Ospedaliera San Martino, Genova,  16132,  Italy; Recruiting
Marco Gobbi  0039-010-3538995    gobbi@uniqe.it 
Marco Gobbi, MD,  Principal Investigator

      Policlinico San Matteo, Pavia,  27100,  Italy; Recruiting
Mario Lazzarino  0039-0382-503596    m.lazzarino@smatteo.pv.it 
Mario Lazzarino, MD,  Principal Investigator

Poland
      Institute of Internal Diseases University of Medicine, Gdansk,  80-211,  Poland; Recruiting
Hanna Ciepluch  0048 58 349 22 30 
Andrezej Hellman, MD,  Principal Investigator

      Medical Academy of Bialystok, Bialystok,  15-276,  Poland; Recruiting
Janusz Kloczko  0048 85 7468603    hem@amb.ac.bialystok.pl 
Janusz Kloczko, MD,  Principal Investigator

      Medical University of Lodz, Lodz,  93-509,  Poland; Recruiting
Anna Pluzanska  0048 43 689 54 30 
Anna Pluzanska, MD,  Principal Investigator

Spain
      Clinica Universitaria de Navarra, Pamplona,  31080,  Spain; Recruiting
Felipe Prosper  0034 94 829 63 97 
Felipe Prosper, MD,  Principal Investigator

      Hospital Universitario Marques de Valdecilla, Santander,  39008,  Spain; Recruiting
Aranzazu Bermudez  0034 94 220 25 73 
Julio Baro, MD,  Principal Investigator

      Hospital Clinic, Barcelona,  08036,  Spain; Recruiting
Joan Blade  0034 93 227 54 28 
Joan Blade, MD,  Principal Investigator

      Hospital Universitario de la Princessa, Madrid,  28006,  Spain; Recruiting
Adrian Alegre  0034 91 520 24 58 
Adrian Alegre, MD,  Principal Investigator

      Hospital Universitario de Salamanca, Salamanca,  37007,  Spain; Recruiting
Jesus San Miguel  0034 92 329 13 84 
Jesus San Miguel, MD,  Principal Investigator

Switzerland
      Universitatsspital Zurich, Zurich,  8091,  Switzerland; Recruiting
Christian Taverna  0041-1-25-52-153    christian.taverna@dim.usz.ch 
Christian Taverna, MD,  Principal Investigator

United Kingdom
      Guys Hospital, London,  SE19RT,  United Kingdom; Recruiting
Stephen Schey  0044-207-955-4003    steve.schey@gstt.sthames.nhs.uk 
Stephen Schey, MD,  Principal Investigator

More Information

Study ID Numbers:  THAL-MM-003
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  April 4, 2003
ClinicalTrials.gov Identifier:  NCT00057564
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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