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

September 18, 2017 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Revlimid
  • lenalidomide
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 Names:
  • 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 Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 weeks (median Time To Progression of CC-5013/Dex treatment group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
170 weeks (median overall survival of CC-5013/Dex treatment group)
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.
Up to Unblinding (07 Jun 2005)
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.
30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MM-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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