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

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ClinicalTrials.gov Identifier: NCT00056160
Recruitment Status : Completed
First Posted : March 7, 2003
Results First Posted : March 3, 2010
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-5013 Drug: Dexamethasone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2003
Actual Primary Completion Date : November 1, 2005
Actual Study Completion Date : October 1, 2008


Arm Intervention/treatment
Experimental: CC-5013/Dex
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Drug: CC-5013
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.
Other Names:
  • lenalidomide
  • Revlimid

Drug: Dexamethasone
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.
Other Name: Decadron

Experimental: Placebo/Dex
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Drug: Dexamethasone
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.
Other Name: Decadron




Primary Outcome Measures :
  1. Time to Tumor Progression (TTP) [ Time Frame: 60 weeks (median Time To Progression of CC-5013/Dex treatment group) ]
    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 :
  1. Overall Survival [ Time Frame: 170 weeks (median overall survival of CC-5013/Dex treatment group) ]
    Overall survival was calculated as the time from randomization to death from any cause.

  2. Myeloma Response [ Time Frame: Up to Unblinding (07 Jun 2005) ]
    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.

  3. 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.) [ Time Frame: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056160


  Hide Study Locations
Locations
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United States, Alabama
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
UCLA School of Medicine
Los Angeles, California, United States, 90095
UCSF California
San Francisco, California, United States, 94143
Stanford University Medical Center, Division of Hematology
Stanford, California, United States, 94305-5112
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic- Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami
Miami, Florida, United States, 33136
Oncology Hematology Consultants
Sarasota, Florida, United States, 34239
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912-3125
United States, Illinois
Northwestern University Med Ctr
Chicago, Illinois, United States, 60611-2927
Rush Cancer Institute Section of Hematology
Chicago, Illinois, United States, 60612-3824
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana Cancer Research Institute
Indianapolis, Indiana, United States, 46202-5254
United States, Iowa
University of Iowa Hospital Clinic
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ocshner Clinical Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins Medicine Department of Oncology
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine- Sherman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
New York Presbyterian Hospital
New York, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
MBCCOP Our Lady of Mercy Cancer Center New York Medical College
The Bronx, New York, United States, 10466
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157-1023
United States, Ohio
Cleveland Clinic Myeloma Program
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Kaiser Permanente Northwest Region Center for Health Research
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston Hematology/Oncology P.A.
Charleston, South Carolina, United States, 29403
Medical University of SC
Charleston, South Carolina, United States, 29425
South Carolina Oncology Group
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203-1632
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Froedtert Hospital/BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-3522
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G1Z2
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5J2M9
Canada, Quebec
Hospital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V2H1
McGill University
Montreal, Quebec, Canada, PQH2W1S6
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Robert Knight, MD Celgene Corporation

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00056160     History of Changes
Other Study ID Numbers: CC-5013-MM-009
First Posted: March 7, 2003    Key Record Dates
Results First Posted: March 3, 2010
Last Update Posted: October 19, 2017
Last Verified: September 2017
Keywords provided by Celgene:
Multiple Myeloma
Refractory and Relapsed
Revlimid
CC5013
Additional relevant MeSH terms:
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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
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors