Back to resultsCC-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
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Refractory and Relapsed, Revlimid, CC5013
Eligibility Criteria
Inclusion Criteria: Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma. No more than 3 previous anti-myeloma regimens No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization. Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample). Exclusion Criteria: Prior development of disease progression during high-dose dexamethasone containing therapy. Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed Laboratory abnormalities: Platelet count less than 75,000/mm cubed Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years. Known hypersensitivity to thalidomide or dexamethasone. Development of a desquamating rash while taking thalidomide.
Sites / Locations
- Clinical Research Consultants, Inc.
- City of Hope National Medical Center
- UCLA School of Medicine
- UCSF California
- Stanford University Medical Center, Division of Hematology
- Yale University School of Medicine
- University of Florida
- Mayo Clinic- Jacksonville
- University of Miami
- Oncology Hematology Consultants
- H Lee Moffitt Cancer Center
- Emory University
- Medical College of Georgia
- Northwestern University Med Ctr
- Rush Cancer Institute Section of Hematology
- Loyola University Medical Center
- Indiana Cancer Research Institute
- University of Iowa Hospital Clinic
- Ocshner Clinical Foundation
- Johns Hopkins Medicine Department of Oncology
- Dana Farber Cancer Institute
- University Of Michigan Comprehensive Cancer Center
- Karmanos Cancer Institute
- Mayo Clinic Cancer Center
- Washington University School of Medicine- Sherman Cancer Center
- Hackensack University Medical Center
- Roswell Park Cancer Institute
- St. Vincent's Comprehensive Cancer Center
- New York Presbyterian Hospital
- SUNY Upstate Medical University
- MBCCOP Our Lady of Mercy Cancer Center New York Medical College
- Duke University Medical Center
- Wake Forest University School of Medicine
- Cleveland Clinic Myeloma Program
- Ohio State University
- Kaiser Permanente Northwest Region Center for Health Research
- University of Pennsylvania Cancer Center
- University of Pittsburgh
- Charleston Hematology/Oncology P.A.
- Medical University of SC
- South Carolina Oncology Group
- Sarah Cannon Cancer Center
- MD Anderson Cancer Center
- Froedtert Hospital/BMT Medical College of Wisconsin
- Cross Cancer Institute
- Dalhousie University
- Princess Margaret Hospital
- Hospital Charles LeMoyne
- McGill University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CC-5013/Dex
Placebo/Dex
Arm Description
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Outcomes
Primary Outcome Measures
Time to Tumor Progression (TTP)
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Secondary Outcome Measures
Overall Survival
Overall survival was calculated as the time from randomization to death from any cause.
Myeloma Response
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00056160
Brief Title
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Official Title
A Multicenter, 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
October 1, 2008 (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
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Detailed Description
This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Refractory and Relapsed, Revlimid, CC5013
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CC-5013/Dex
Arm Type
Experimental
Arm Description
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Arm Title
Placebo/Dex
Arm Type
Experimental
Arm Description
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Intervention Type
Drug
Intervention Name(s)
CC-5013
Other Intervention Name(s)
lenalidomide, Revlimid
Intervention Description
Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
Primary Outcome Measure Information:
Title
Time to Tumor Progression (TTP)
Description
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Time Frame
60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was calculated as the time from randomization to death from any cause.
Time Frame
170 weeks (median overall survival of CC-5013/Dex treatment group)
Title
Myeloma Response
Description
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
Time Frame
Up to Unblinding (07 Jun 2005)
Title
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
Description
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Time Frame
30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
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.
No more than 3 previous anti-myeloma regimens
No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Exclusion Criteria:
Prior development of disease progression during high-dose dexamethasone containing therapy.
Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
Laboratory abnormalities: Platelet count less than 75,000/mm cubed
Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal
Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL
Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
Known hypersensitivity to thalidomide or dexamethasone.
Development of a desquamating rash while taking thalidomide.
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
Clinical Research Consultants, Inc.
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center, Division of Hematology
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5112
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic- Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Oncology Hematology Consultants
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
H Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3125
Country
United States
Facility Name
Northwestern University Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Rush Cancer Institute Section of Hematology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3824
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana Cancer Research Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5254
Country
United States
Facility Name
University of Iowa Hospital Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ocshner Clinical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins Medicine Department of Oncology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University Of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine- Sherman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
MBCCOP Our Lady of Mercy Cancer Center New York Medical College
City
The Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1023
Country
United States
Facility Name
Cleveland Clinic Myeloma Program
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Kaiser Permanente Northwest Region Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Charleston Hematology/Oncology P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Medical University of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
South Carolina Oncology Group
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Froedtert Hospital/BMT Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5J2M9
Country
Canada
Facility Name
Hospital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
PQH2W1S6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18032763
Citation
Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
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
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
We'll reach out to this number within 24 hrs