A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
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.
1 other identifier
interventional
351
14 countries
60
Brief 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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Jan 2003
Longer than P75 for phase_3 multiple-myeloma
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 17, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2013
CompletedResults Posted
Study results publicly available
March 4, 2015
CompletedOctober 19, 2017
September 1, 2017
2.8 years
January 17, 2007
February 13, 2015
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
From randomization up to cut-off date of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
From randomization up to cut-off date of 02 March 2008; up to 51 months
Secondary Outcomes (8)
Kaplan-Meier Estimate of Overall Survival (OS)
Randomization to data cut off of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Randomization to data cut off of 02 March 2008; up to 51 months
Summary of Myeloma Response Rates Based on Best Response Assessment
Randomization to 03 August 2005; up to 24 months
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Randomization to data cut-off of 02 Mar 2008; up to 51 months
Number of Participants With Adverse Events (AE)
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
- +3 more secondary outcomes
Study Arms (2)
CC-5013 plus dexamethasone
EXPERIMENTALArm 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.
Dexamethasone plus placebo
EXPERIMENTALArm 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.
Interventions
25 mg daily for 21 days 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 placebo capsules will be administered for 28 days of every cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (69)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
East Melbourne, Victoria, 3006, Australia
The Alfred Hospital
Prahran, Victoria, 3121, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Box Hill Hospital
Box Hill, VIC 3128, Australia
Frankston Hospital Oncology Research
Frankston, VIC 3199, Australia
Royal Brisbane Hospital
Herston, QLD4029, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
Mater Public Hospital
South Brisbane, QLD 4101, Australia
University Hospital of Salzburg St Johanns Spital
Salzburg, A -5020, Austria
Wilhelminenspital
Vienna, 1160, Austria
CHU Saint-Luc
Brussels, 1200, Belgium
UZ Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Lyon Sud
Chemin Grand Revoyet, 69495 Pierre Benite cedex, France
Hopital Claude Huriez
Lille, 59037, France
Centre Hospitalier Hotel-Dieu
Nantes, France
Hopital Saint-Loius
Paris, 75010, France
Chu de Bordeaux Groupe Hospitalier Sud
Pessac, 33640, France
CHU Purpan
Toulouse, TSA 40031-31059, France
CHU Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Charite
Berlin, 13125, Germany
Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
Berlin, 13353, Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, 40225, Germany
Universitaetsklinkum Erlangen
Erlangen, 91054, Germany
Klininkum der Johann-Wolfgang-Goethe-Universtat
Frankfurt am Main, 60590, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
Heidelberg, 69120, Germany
Klinikum der Univeristact Muenchen
München, 80336, Germany
Universitatsklinik Muenster Medizinische Klinik A
Münster, 48129, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
"Alexandras" General Hospital of Athens
Athens, 11538, Greece
University Hospital GalwayHaematology Department
Galway, Co. Galway, Ireland
Belfast City HospitalHaematology Department
Belfast, BT9 7AB, Ireland
Hope Directorate Haematology Oncology Service St. James Hospital
Dublin, Ireland
MidWestern Regional Hospital
Limerick, Ireland
Rambam Medical Center
Haifa, 31096, Israel
Hadassah University Hospital
Jerusalem, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Policlinico Sant'Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera San Martino
Genova, 16132, Italy
Ospedale Niguarda Ca Granda
Milan, 20162, Italy
Policlinico San Matteo
Pavia, 27100, Italy
Univerita La Sapien
Roma, 00161, Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torio, 10126, Italy
Policlinico Universitario a Gesttione diretta di Udine
Udine, 33100, Italy
Institute of Internal Diseases University of Medicine
Gdansk, 80-211, Poland
University School of Medicine
Lublin, 20-290, Poland
Institute of Haematology and Blood Transfusion
Warsaw, 00-957, Poland
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario de la Princessa
Madrid, 28006, Spain
Hospital Doce de Octubre
Madrid, 28041, Spain
Clinica Universitaria de Navarra
Pamplona, 31080, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universtario Marques de Valdecilla
Santander, 39008, Spain
Sahlgrenska University Hospital Department of Hematology and Coagulation
Gothenburg, S-413 45, Sweden
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Cherkassy Regional Oncology Center
Cherkassy, 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4
Dnipro, 49044, Ukraine
Kiev Bone Marrow Transplantation Center Bone Marrow Department
Kiev, 03115, Ukraine
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
Kiev, 04060, Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
Lviv, 79044, Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lviv, 79044, Ukraine
Odess Regional Clinical Hospital
Odesa, 65025, Ukraine
Zhitomir Regional Clinical Hospital
Zhytomyr, 10003, Ukraine
University College Hospital Trust
London, Bloomsbury, WC1E 6AU, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Haematology Dept, 4th Floor Thomas Guy House
London, SE1 9RT, United Kingdom
Related Publications (4)
Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
PMID: 18032762RESULTSan-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.
PMID: 21273172DERIVEDZangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.
PMID: 19901114DERIVEDWang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.
PMID: 18799726DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain, Senior Manager
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2007
First Posted
January 18, 2007
Study Start
January 1, 2003
Primary Completion
November 1, 2005
Study Completion
November 12, 2013
Last Updated
October 19, 2017
Results First Posted
March 4, 2015
Record last verified: 2017-09