A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Last updated: September 18, 2017
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT00424047
CC-5013-MM-010
  • Ages > 18
  • All Genders

Study Summary

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

  • Measurable levels of myeloma paraprotein in serum or urine (24-hour collectionsample).

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2

  • Females of childbearing potential must have a negative serum or urine pregnancy testwithin 7 days of starting study drug

Exclusion

Exclusion Criteria:

  • Prior development of disease progression during high-dose dexamethasone containingtherapy

  • Pregnant or lactating females

  • The development of a desquamating rash while taking thalidomide

  • Use of any standard/experimental anti-myeloma therapy within 28 days of randomizationor use of any experimental non-drug therapy within 56 days of initiation of drugtreatment

  • Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3

  • Laboratory abnormalities: Platelet count < 75,000/mm3

  • Laboratory abnormalities: Serum creatinine > 2.5 mg/dL

  • Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal

  • Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL

  • Prior history of malignancies other than multiple myeloma unless the subject has beenfree of the disease for ≥ 3 years.

Study Design

Total Participants: 351
Study Start date:
January 01, 2003
Estimated Completion Date:
November 12, 2013

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology

    East Melbourne, Victoria 3006
    Australia

    Site Not Available

  • The Alfred Hospital

    Prahran, Victoria 3121
    Australia

    Site Not Available

  • Border Medical Oncology

    Wodonga, Victoria 3690
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, VIC 3128
    Australia

    Site Not Available

  • Frankston Hospital Oncology Research

    Frankston, VIC 3199
    Australia

    Site Not Available

  • Royal Brisbane Hospital

    Herston, QLD4029
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville, 3050
    Australia

    Site Not Available

  • Mater Public Hospital

    South Brisbane, QLD 4101
    Australia

    Site Not Available

  • University Hospital of Salzburg St Johanns Spital

    Salzburg, A -5020
    Austria

    Site Not Available

  • Wilhelminenspital

    Vienna, 1160
    Austria

    Site Not Available

  • CHU Saint-Luc

    Brussel, 1200
    Belgium

    Site Not Available

  • UZ Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Chemin Grand Revoyet, 69495 Pierre Benite cedex
    France

    Site Not Available

  • Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Centre Hospitalier Hotel-Dieu

    Nantes,
    France

    Site Not Available

  • Hopital Saint-Loius

    Paris, 75010
    France

    Site Not Available

  • Chu de Bordeaux Groupe Hospitalier Sud

    Pessac, 33640
    France

    Site Not Available

  • CHU Purpan

    Toulouse cedex 9, TSA 40031-31059
    France

    Site Not Available

  • CHU Nancy - Hopital Brabois

    Vandoeuvre, 54511
    France

    Site Not Available

  • Universitatsklinik Charite Medizinische Fakultaet der Humboldt Universitaet zu Berlin

    13353 Berlin,
    Germany

    Site Not Available

  • Universitaetsklinikum Charite

    Berlin, 13125
    Germany

    Site Not Available

  • Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

    Dusseldorf, 40225
    Germany

    Site Not Available

  • Universitaetsklinkum Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Klininkum der Johann-Wolfgang-Goethe-Universtat

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitatsklinik Muenster Medizinische Klinik A

    Muenster, 48129
    Germany

    Site Not Available

  • Klinikum der Univeristact Muenchen

    Munchen, 80336
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tubingen, 72076
    Germany

    Site Not Available

  • "Alexandras" General Hospital of Athens

    Athens, 11538
    Greece

    Site Not Available

  • University Hospital GalwayHaematology Department

    Galway, Co. Galway
    Ireland

    Site Not Available

  • Belfast City HospitalHaematology Department

    Belfast, BT9 7AB
    Ireland

    Site Not Available

  • Hope Directorate Haematology Oncology Service St. James Hospital

    Dublin 8,
    Ireland

    Site Not Available

  • MidWestern Regional Hospital

    Limerick,
    Ireland

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Hadassah University Hospital

    Jerusalem,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Policlinico Sant'Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Ospedale Niguarda Ca Granda

    Milano, 20162
    Italy

    Site Not Available

  • Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Univerita La Sapien

    Roma, 00161
    Italy

    Site Not Available

  • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

    Torio, 10126
    Italy

    Site Not Available

  • Policlinico Universitario a Gesttione diretta di Udine

    Udine, 33100
    Italy

    Site Not Available

  • Institute of Internal Diseases University of Medicine

    Gdansk, 80-211
    Poland

    Site Not Available

  • University School of Medicine

    Lublin, 20-290
    Poland

    Site Not Available

  • Institute of Haematology and Blood Transfusion

    Warsaw, 00-957
    Poland

    Site Not Available

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Doce de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario de la Princessa

    Madrid, 28006
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, 31080
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universtario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Sahlgrenska University Hospital Department of Hematology and Coagulation

    Goteborg, S-413 45
    Sweden

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen,
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Cherkassy Regional Oncology Center

    Cherkassy, 18009
    Ukraine

    Site Not Available

  • Dnepropetrovsk City Clinical Hospital #4

    Dnepropetrovsk, 49044
    Ukraine

    Site Not Available

  • Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

    Kiev, 04060
    Ukraine

    Site Not Available

  • Kiev Bone Marrow Transplantation Center Bone Marrow Department

    Kiev, 03115
    Ukraine

    Site Not Available

  • Institute of Blood Pathology and Transfusion Medicine of the UAMS

    Lviv, 79044
    Ukraine

    Site Not Available

  • Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department

    Lvov, 79044
    Ukraine

    Site Not Available

  • Odess Regional Clinical Hospital

    Odessa, 65025
    Ukraine

    Site Not Available

  • Zhitomir Regional Clinical Hospital

    Zhitomir, 10003
    Ukraine

    Site Not Available

  • University College Hospital Trust

    London, Bloomsbury WC1E 6AU
    United Kingdom

    Site Not Available

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • Haematology Dept, 4th Floor Thomas Guy House

    London, SE1 9RT
    United Kingdom

    Site Not Available

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