Clinical trial NCT00424047: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Celgene
Revlimid
CC-5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."


Eligibility 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.

Primary outcomes:
measure: Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
timeFrame: From randomization up to cut-off date of 03 August 2005; up to 24 months
measure: Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
timeFrame: From randomization up to cut-off date of 02 March 2008; up to 51 months
Secondary outcomes:
measure: Kaplan-Meier Estimate of Overall Survival (OS)
timeFrame: Randomization to data cut off of 03 August 2005; up to 24 months
measure: Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
timeFrame: Randomization to data cut off of 02 March 2008; up to 51 months
measure: Summary of Myeloma Response Rates Based on Best Response Assessment
timeFrame: Randomization to 03 August 2005; up to 24 months
measure: Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
timeFrame: Randomization to data cut-off of 02 Mar 2008; up to 51 months
measure: Number of Participants With Adverse Events (AE)
timeFrame: 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
measure: Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
timeFrame: Up to unblinding data cut off of 03 August 2005; up to 24 months
measure: Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
timeFrame: Randomization to cut off date of 03 August 2005; up to 24 months
measure: Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
timeFrame: Randomization to cut off date of 02 March 2008; up to 51 months
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
state: Victoria
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Frankston
country: Australia
facility: Frankston Hospital Oncology Research
city: Herston
country: Australia
facility: Royal Brisbane Hospital
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
city: South Brisbane
country: Australia
facility: Mater Public Hospital
city: Salzburg
country: Austria
facility: University Hospital of Salzburg St Johanns Spital
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Brussel
country: Belgium
facility: CHU Saint-Luc
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Chemin Grand Revoyet
country: France
facility: Centre Hospitalier Lyon Sud
city: Lille
country: France
facility: Hopital Claude Huriez
city: Nantes
country: France
facility: Centre Hospitalier Hotel-Dieu
city: Paris
country: France
facility: Hopital Saint-Loius
city: Pessac
country: France
facility: Chu de Bordeaux Groupe Hospitalier Sud
city: Toulouse cedex 9
country: France
facility: CHU Purpan
city: Vandoeuvre
country: France
facility: CHU Nancy - Hopital Brabois
city: Berlin
country: Germany
facility: Universitaetsklinikum Charite
city: Berlin
country: Germany
facility: Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
city: Dusseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
city: Erlangen
country: Germany
facility: Universitaetsklinkum Erlangen
city: Frankfurt am Main
country: Germany
facility: Klininkum der Johann-Wolfgang-Goethe-Universtat
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
city: Muenster
country: Germany
facility: Universitatsklinik Muenster Medizinische Klinik A
city: Munchen
country: Germany
facility: Klinikum der Univeristact Muenchen
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Athens
country: Greece
facility: "Alexandras" General Hospital of Athens
city: Galway
country: Ireland
facility: University Hospital GalwayHaematology Department
state: Co. Galway
city: Belfast
country: Ireland
facility: Belfast City HospitalHaematology Department
city: Dublin 8
country: Ireland
facility: Hope Directorate Haematology Oncology Service St. James Hospital
city: Limerick
country: Ireland
facility: MidWestern Regional Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Department of Hematology
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Univerita La Sapien
city: Torio
country: Italy
facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
city: Udine
country: Italy
facility: Policlinico Universitario a Gesttione diretta di Udine
city: Gdansk
country: Poland
facility: Institute of Internal Diseases University of Medicine
city: Lublin
country: Poland
facility: University School of Medicine
city: Warsaw
country: Poland
facility: Institute of Haematology and Blood Transfusion
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario de la Princessa
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universtario Marques de Valdecilla
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital Department of Hematology and Coagulation
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Oncology Center
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Clinical Hospital #4
city: Kiev
country: Ukraine
facility: Kiev Bone Marrow Transplantation Center Bone Marrow Department
city: Kiev
country: Ukraine
facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
city: Lviv
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS
city: Lvov
country: Ukraine
facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
city: Odessa
country: Ukraine
facility: Odess Regional Clinical Hospital
city: Zhitomir
country: Ukraine
facility: Zhitomir Regional Clinical Hospital
city: London
country: United Kingdom
facility: University College Hospital Trust
state: Bloomsbury
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: London
country: United Kingdom
facility: Haematology Dept, 4th Floor Thomas Guy House
Study officials:
affiliation: Celgene Corporation
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: San-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.
citation: Zangari 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.
citation: Wang 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.