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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00424047
First received: January 17, 2007
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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."


Condition Intervention Phase
Multiple Myeloma
Drug: CC-5013 plus dexamethasone
Drug: Dexamethasone plus Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Time to tumor progression (TTP) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Time from randomization to the first documentation of progressive disease based on the Myeloma response determination criteria developed by Bladé et al 1998


Secondary Outcome Measures:
  • Number of patients who survived [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]
    Time from randomization to death from any cause

  • Number of participants with adverse events [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Myeloma response rate [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Myeloma response determination criteria developed by Bladé et al 1998

  • Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Time for randomization to the date of the first occurred of a symptomatic SRE (clinical need for radiotherapy or surgery to bone)

  • Time to first worsening on the Eastern Cooperative Oncology Group (ECOG) performance scale [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]
    Time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization


Estimated Enrollment: 351
Study Start Date: January 2003
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-5013 plus dexamethasone
Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.
Drug: CC-5013 plus dexamethasone
25 mg daily for 21 days every 28 days.
Other Names:
  • Revlimid
  • lenalidomide
Experimental: Dexamethasone plus placebo
Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Drug: Dexamethasone plus Placebo
Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Other Names:
  • Dexamethasone
  • Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 collection sample).
  • 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 test within 7 days of starting study drug

Exclusion Criteria:

  • Prior development of disease progression during high-dose dexamethasone containing therapy
  • 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 randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
  • 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 been free of the disease for ≥ 3 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424047

  Hide Study Locations
Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
East Melbourne, Victoria, Australia, 3006
The Alfred Hospital
Prahran, Victoria, Australia, 3121
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Australia
Box Hill Hospital
Box Hill, Australia, VIC 3128
Frankston Hospital Oncology Research
Frankston, Australia, VIC 3199
Royal Brisbane Hospital
Herston, Australia, QLD4029
The Royal Melbourne Hospital
Parkville, Australia, 3050
Mater Public Hospital
South Brisbane, Australia, QLD 4101
Austria
University Hospital of Salzburg St Johanns Spital
Salzburg, Austria, A -5020
Wilhelminenspital
Vienna, Austria, 1160
Belgium
CHU Saint-Luc
Brussel, Belgium, 1200
UZ Gasthuisberg
Leuven, Belgium, 3000
France
Centre Hospitalier Lyon Sud
Chemin Grand Revoyet, France, 69495 Pierre Benite cedex
Hopital Claude Huriez
Lille, France, 59037
Centre Hospitalier Hotel-Dieu
Nantes, France
Hopital Saint-Loius
Paris, France, 75010
Chu de Bordeaux Groupe Hospitalier Sud
Pessac, France, 33640
CHU Purpan
Toulouse cedex 9, France, TSA 40031-31059
CHU Nancy - Hopital Brabois
Vandoeuvre, France, 54511
Germany
Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
Berlin, Germany, 13353
Universitaetsklinikum Charite
Berlin, Germany, 13125
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Dusseldorf, Germany, 40225
Universitaetsklinkum Erlangen
Erlangen, Germany, 91054
Klininkum der Johann-Wolfgang-Goethe-Universtat
Frankfurt am Main, Germany, 60590
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
Heidelberg, Germany, 69120
Universitatsklinik Muenster Medizinische Klinik A
Muenster, Germany, 48129
Klinikum der Univeristact Muenchen
Munchen, Germany, 80336
Universitaetsklinikum Tuebingen
Tubingen, Germany, 72076
Greece
"Alexandras" General Hospital of Athens
Athens, Greece, 11538
Ireland
University Hospital GalwayHaematology Department
Galway, Co. Galway, Ireland
Belfast City HospitalHaematology Department
Belfast, Ireland, BT9 7AB
Hope Directorate Haematology Oncology Service St. James Hospital
Dublin 8, Ireland
MidWestern Regional Hospital
Limerick, Ireland
Israel
Rambam Medical Center
Haifa, Israel, 31096
Hadassah University Hospital
Jerusalem, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, Israel, 64239
The Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera San Martino
Genova, Italy, 16132
Ospedale Niguarda Ca Granda
Milano, Italy, 20162
Policlinico San Matteo
Pavia, Italy, 27100
Univerita La Sapien
Roma, Italy, 00161
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torio, Italy, 10126
Policlinico Universitario a Gesttione diretta di Udine
Udine, Italy, 33100
Poland
Institute of Internal Diseases University of Medicine
Gdansk, Poland, 80-211
University School of Medicine
Lublin, Poland, 20-290
Institute of Haematology and Blood Transfusion
Warsaw, Poland, 00-957
Spain
Hospital Clinic
Barcelona, Spain, 08036
Hospital Doce de Octubre
Madrid, Spain, 28041
Hospital Universitario de la Princessa
Madrid, Spain, 28006
Clinica Universitaria de Navarra
Pamplona, Spain, 31080
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universtario Marques de Valdecilla
Santander, Spain, 39008
Sweden
Sahlgrenska University Hospital Department of Hematology and Coagulation
Goteborg, Sweden, S-413 45
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Kantonsspital St. Gallen
St. Gallen, Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Ukraine
Cherkassy Regional Oncology Center
Cherkassy, Ukraine, 18009
Dnepropetrovsk City Clinical Hospital #4
Dnepropetrovsk, Ukraine, 49044
Kiev Bone Marrow Transplantation Center Bone Marrow Department
Kiev, Ukraine, 03115
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
Kiev, Ukraine, 04060
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lviv, Ukraine, 79044
Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
Lvov, Ukraine, 79044
Odess Regional Clinical Hospital
Odessa, Ukraine, 65025
Zhitomir Regional Clinical Hospital
Zhitomir, Ukraine, 10003
United Kingdom
University College Hospital Trust
London, Bloomsbury, United Kingdom, WC1E 6AU
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Haematology Dept, 4th Floor Thomas Guy House
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Knight, MD Celgene Corporation
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00424047     History of Changes
Other Study ID Numbers: CC-5013-MM-010
Study First Received: January 17, 2007
Last Updated: September 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Multiple Myeloma
Celgene
Revlimid
CC-5013

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 17, 2014