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

September 9, 2015 updated by: Celgene Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A (Thalidomide & Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Drug: A (Thalidomide + Dexamethasone)
Thalidomide 50mg/day + Dexamethasone 40mg
Other Names:
  • Thalidomide
Placebo Comparator: B (Dexamethasone and placebo)
Dexamethasone and placebo
Drug: B (Placebo + Dexamethasone)
Placebo + Dexamethasone 40mg
Other Names:
  • Dexamethasone
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to tumor progression (TTP)
Time Frame: Up to 3 years
Time to tumor progression (TTP)
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who survived
Time Frame: Up to 3 years
Number of patients who survived
Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Time Frame: Up to 3 years
Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)
Up to 3 years
Myeloma response rate
Time Frame: Up to 3 years
Myeloma response determination criteria developed by Bladé et al 1998
Up to 3 years
Number of participants with adverse events
Time Frame: Up to 3 years
Number of participants with adverse events
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 8, 2003

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THAL-MM-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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