search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CC-5013 plus dexamethasone
Dexamethasone plus Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Celgene, Revlimid, CC-5013

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Prince Alfred Hospital
  • Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
  • The Alfred Hospital
  • Border Medical Oncology
  • Box Hill Hospital
  • Frankston Hospital Oncology Research
  • Royal Brisbane Hospital
  • The Royal Melbourne Hospital
  • Mater Public Hospital
  • University Hospital of Salzburg St Johanns Spital
  • Wilhelminenspital
  • CHU Saint-Luc
  • UZ Gasthuisberg
  • Centre Hospitalier Lyon Sud
  • Hopital Claude Huriez
  • Centre Hospitalier Hotel-Dieu
  • Hopital Saint-Loius
  • Chu de Bordeaux Groupe Hospitalier Sud
  • CHU Purpan
  • CHU Nancy - Hopital Brabois
  • Universitaetsklinikum Charite
  • Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
  • Universitaetsklinkum Erlangen
  • Klininkum der Johann-Wolfgang-Goethe-Universtat
  • Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
  • Universitatsklinik Muenster Medizinische Klinik A
  • Klinikum der Univeristact Muenchen
  • Universitaetsklinikum Tuebingen
  • "Alexandras" General Hospital of Athens
  • University Hospital GalwayHaematology Department
  • Belfast City HospitalHaematology Department
  • Hope Directorate Haematology Oncology Service St. James Hospital
  • MidWestern Regional Hospital
  • Rambam Medical Center
  • Hadassah University Hospital
  • Tel Aviv Sourasky Medical Center Department of Hematology
  • The Chaim Sheba Medical Center
  • Policlinico Sant'Orsola-Malpighi
  • Azienda Ospedaliera San Martino
  • Ospedale Niguarda Ca Granda
  • Policlinico San Matteo
  • Univerita La Sapien
  • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
  • Policlinico Universitario a Gesttione diretta di Udine
  • Institute of Internal Diseases University of Medicine
  • University School of Medicine
  • Institute of Haematology and Blood Transfusion
  • Hospital Clinic
  • Hospital Universitario de la Princessa
  • Hospital Doce de Octubre
  • Clinica Universitaria de Navarra
  • Hospital Universitario de Salamanca
  • Hospital Universtario Marques de Valdecilla
  • Sahlgrenska University Hospital Department of Hematology and Coagulation
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Kantonsspital St. Gallen
  • Universitätsspital Zürich
  • Cherkassy Regional Oncology Center
  • Dnepropetrovsk City Clinical Hospital #4
  • Kiev Bone Marrow Transplantation Center Bone Marrow Department
  • Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
  • Institute of Blood Pathology and Transfusion Medicine of the UAMS
  • Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
  • Odess Regional Clinical Hospital
  • Zhitomir Regional Clinical Hospital
  • University College Hospital Trust
  • Bristol Haematology and Oncology Centre
  • Haematology Dept, 4th Floor Thomas Guy House

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CC-5013 plus dexamethasone

Dexamethasone plus placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Kaplan-Meier Estimate of Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Summary of Myeloma Response Rates Based on Best Response Assessment
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Number of Participants With Adverse Events (AE)
An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Time from randomization to the date of the first occurrence 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
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.

Full Information

First Posted
January 17, 2007
Last Updated
September 18, 2017
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT00424047
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
November 1, 2005 (Actual)
Study Completion Date
November 12, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Celgene, Revlimid, CC-5013

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-5013 plus dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
Dexamethasone plus placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CC-5013 plus dexamethasone
Other Intervention Name(s)
Revlimid, lenalidomide
Intervention Description
25 mg daily for 21 days every 28 days.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone plus Placebo
Other Intervention Name(s)
Dexamethasone, Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Description
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.
Time Frame
From randomization up to cut-off date of 03 August 2005; up to 24 months
Title
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Description
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.
Time Frame
From randomization up to cut-off date of 02 March 2008; up to 51 months
Secondary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Overall Survival (OS)
Description
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame
Randomization to data cut off of 03 August 2005; up to 24 months
Title
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Description
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame
Randomization to data cut off of 02 March 2008; up to 51 months
Title
Summary of Myeloma Response Rates Based on Best Response Assessment
Description
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Time Frame
Randomization to 03 August 2005; up to 24 months
Title
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Description
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Time Frame
Randomization to data cut-off of 02 Mar 2008; up to 51 months
Title
Number of Participants With Adverse Events (AE)
Description
An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Time Frame
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
Title
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Description
Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
Time Frame
Up to unblinding data cut off of 03 August 2005; up to 24 months
Title
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Description
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Time Frame
Randomization to cut off date of 03 August 2005; up to 24 months
Title
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
Description
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Time Frame
Randomization to cut off date of 02 March 2008; up to 51 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3006
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
VIC 3128
Country
Australia
Facility Name
Frankston Hospital Oncology Research
City
Frankston
ZIP/Postal Code
VIC 3199
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
ZIP/Postal Code
QLD4029
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Mater Public Hospital
City
South Brisbane
ZIP/Postal Code
QLD 4101
Country
Australia
Facility Name
University Hospital of Salzburg St Johanns Spital
City
Salzburg
ZIP/Postal Code
A -5020
Country
Austria
Facility Name
Wilhelminenspital
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
CHU Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Lyon Sud
City
Chemin Grand Revoyet
ZIP/Postal Code
69495 Pierre Benite cedex
Country
France
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Hotel-Dieu
City
Nantes
Country
France
Facility Name
Hopital Saint-Loius
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Chu de Bordeaux Groupe Hospitalier Sud
City
Pessac
ZIP/Postal Code
33640
Country
France
Facility Name
CHU Purpan
City
Toulouse cedex 9
ZIP/Postal Code
TSA 40031-31059
Country
France
Facility Name
CHU Nancy - Hopital Brabois
City
Vandoeuvre
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Charite
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinkum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klininkum der Johann-Wolfgang-Goethe-Universtat
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinik Muenster Medizinische Klinik A
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Klinikum der Univeristact Muenchen
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
"Alexandras" General Hospital of Athens
City
Athens
ZIP/Postal Code
11538
Country
Greece
Facility Name
University Hospital GalwayHaematology Department
City
Galway
State/Province
Co. Galway
Country
Ireland
Facility Name
Belfast City HospitalHaematology Department
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
Ireland
Facility Name
Hope Directorate Haematology Oncology Service St. James Hospital
City
Dublin 8
Country
Ireland
Facility Name
MidWestern Regional Hospital
City
Limerick
Country
Ireland
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Department of Hematology
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Univerita La Sapien
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
City
Torio
ZIP/Postal Code
10126
Country
Italy
Facility Name
Policlinico Universitario a Gesttione diretta di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Institute of Internal Diseases University of Medicine
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
University School of Medicine
City
Lublin
ZIP/Postal Code
20-290
Country
Poland
Facility Name
Institute of Haematology and Blood Transfusion
City
Warsaw
ZIP/Postal Code
00-957
Country
Poland
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de la Princessa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31080
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universtario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Sahlgrenska University Hospital Department of Hematology and Coagulation
City
Goteborg
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Cherkassy Regional Oncology Center
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk City Clinical Hospital #4
City
Dnepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Kiev Bone Marrow Transplantation Center Bone Marrow Department
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
City
Kiev
ZIP/Postal Code
04060
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine of the UAMS
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
City
Lvov
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Odess Regional Clinical Hospital
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Zhitomir Regional Clinical Hospital
City
Zhitomir
ZIP/Postal Code
10003
Country
Ukraine
Facility Name
University College Hospital Trust
City
London
State/Province
Bloomsbury
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Haematology Dept, 4th Floor Thomas Guy House
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18032762
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. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.
Results Reference
result
PubMed Identifier
21273172
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.
Results Reference
derived
PubMed Identifier
19901114
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.
Results Reference
derived
PubMed Identifier
18799726
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.
Results Reference
derived
Links:
URL
http://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/clinical-study-report-csr-synopses/purposes-of-posting-clinical-study-report-csr-synopses
Description
Link to CSR synopsis

Learn more about this trial

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

We'll reach out to this number within 24 hrs