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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT00056160
Collaborator
(none)
353
Enrollment
49
Locations
2
Arms
69
Actual Duration (Months)
7.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2003
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Tumor Progression (TTP) [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 [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 [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.) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Robert Knight, MD, Celgene Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00056160
    Other Study ID Numbers:
    • CC-5013-MM-009
    First Posted:
    Mar 7, 2003
    Last Update Posted:
    Oct 19, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Celgene
    Multiple Myeloma
    Refractory and Relapsed
    Revlimid
    CC5013
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone
    Lenalidomide

    Study Results

    Participant Flow

    Recruitment Details Subjects in the Placebo/Dex treatment group did not continue participation beyond the period "Up To Unblinding (07 Jun 2005"). Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)".
    Pre-assignment Detail Only subjects in the CC-5013/Dex treatment group participated in the period "Extended Follow-up Cutoff (23 Jul 2008)". Data for the period "Extended Follow-up Cutoff (23 Jul 2008)" subsumes data for the period "Up To Unblinding (07 Jun 2005)".
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Period Title: Up to Unblinding (07 Jun 2005)
    STARTED 177 176
    COMPLETED 64 13
    NOT COMPLETED 113 163
    Period Title: Up to Unblinding (07 Jun 2005)
    STARTED 177 0
    COMPLETED 6 0
    NOT COMPLETED 171 0
    Period Title: Up to Unblinding (07 Jun 2005)
    STARTED 6 0
    COMPLETED 0 0
    NOT COMPLETED 6 0

    Baseline Characteristics

    Arm/Group Title CC-5013/Dex Placebo/Dex Total
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone Total of all reporting groups
    Overall Participants 177 176 353
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    94
    53.1%
    103
    58.5%
    197
    55.8%
    >=65 years
    83
    46.9%
    73
    41.5%
    156
    44.2%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.3
    (9.84)
    62.5
    (9.81)
    62.9
    (9.81)
    Sex: Female, Male (Count of Participants)
    Female
    71
    40.1%
    72
    40.9%
    143
    40.5%
    Male
    106
    59.9%
    104
    59.1%
    210
    59.5%
    Region of Enrollment (participants) [Number]
    United States
    142
    80.2%
    150
    85.2%
    292
    82.7%
    Canada
    35
    19.8%
    26
    14.8%
    61
    17.3%

    Outcome Measures

    1. Primary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Measure Participants 177 176
    Median (95% Confidence Interval) [Weeks]
    60.1
    20.1
    2. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Measure Participants 177 176
    Median (95% Confidence Interval) [Weeks]
    170.1
    136.4
    3. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Measure Participants 177 176
    Number [Participants]
    107
    60.5%
    34
    19.3%
    4. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    Measure Participants 177 176
    Mean (Standard Deviation) [Weeks]
    29.9
    (30.02)
    15.0
    (16.98)

    Adverse Events

    Time Frame Up to 254 weeks (median=48 weeks; mean=77 weeks)
    Adverse Event Reporting Description Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.
    Arm/Group Title CC-5013/Dex Placebo/Dex
    Arm/Group Description CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    All Cause Mortality
    CC-5013/Dex Placebo/Dex
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    CC-5013/Dex Placebo/Dex
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 111/177 (62.7%) 90/175 (51.4%)
    Blood and lymphatic system disorders
    ANAEMIA 2/177 (1.1%) 3 3/175 (1.7%) 3
    FEBRILE NEUTROPENIA 5/177 (2.8%) 5 0/175 (0%) 0
    HYPERVISCOSITY SYNDROME 0/177 (0%) 0 1/175 (0.6%) 1
    LYMPHADENOPATHY 1/177 (0.6%) 1 0/175 (0%) 0
    NEUTROPENIA 4/177 (2.3%) 4 1/175 (0.6%) 1
    PANCYTOPENIA 2/177 (1.1%) 2 0/175 (0%) 0
    THROMBOCYTOPENIA 3/177 (1.7%) 3 2/175 (1.1%) 2
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION 3/177 (1.7%) 3 0/175 (0%) 0
    ANGINA PECTORIS 2/177 (1.1%) 2 0/175 (0%) 0
    ARTERIOSPASM CORONARY 1/177 (0.6%) 1 0/175 (0%) 0
    ATRIAL FIBRILLATION 10/177 (5.6%) 11 1/175 (0.6%) 1
    ATRIAL FLUTTER 2/177 (1.1%) 2 0/175 (0%) 0
    CARDIAC ARREST 0/177 (0%) 0 1/175 (0.6%) 1
    CARDIAC FAILURE CONGESTIVE 4/177 (2.3%) 4 0/175 (0%) 0
    CARDIO-RESPIRATORY ARREST 1/177 (0.6%) 1 0/175 (0%) 0
    CORONARY ARTERY DISEASE 3/177 (1.7%) 3 0/175 (0%) 0
    MYOCARDIAL INFARCTION 1/177 (0.6%) 1 0/175 (0%) 0
    PULMONARY OEDEMA 0/177 (0%) 0 1/175 (0.6%) 1
    SINUS TACHYCARDIA 0/177 (0%) 0 1/175 (0.6%) 1
    TACHYCARDIA 1/177 (0.6%) 1 0/175 (0%) 0
    Endocrine disorders
    ADRENAL INSUFFICIENCY 2/177 (1.1%) 3 0/175 (0%) 0
    Eye disorders
    BLINDNESS 1/177 (0.6%) 1 0/175 (0%) 0
    BLINDNESS TRANSIENT 1/177 (0.6%) 1 0/175 (0%) 0
    CATARACT UNILATERAL 0/177 (0%) 0 1/175 (0.6%) 1
    RETINAL DETACHMENT 1/177 (0.6%) 1 0/175 (0%) 0
    RETINAL VEIN OCCLUSION 1/177 (0.6%) 1 0/175 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL PAIN 3/177 (1.7%) 4 1/175 (0.6%) 1
    APPENDICITIS 1/177 (0.6%) 1 0/175 (0%) 0
    COLITIS 1/177 (0.6%) 1 0/175 (0%) 0
    COLITIS PSEUDOMEMBRANOUS 0/177 (0%) 0 1/175 (0.6%) 1
    CONSTIPATION 2/177 (1.1%) 2 0/175 (0%) 0
    DIARRHOEA 4/177 (2.3%) 4 0/175 (0%) 0
    DIVERTICULAR PERFORATION 0/177 (0%) 0 1/175 (0.6%) 1
    DIVERTICULITIS 1/177 (0.6%) 1 1/175 (0.6%) 1
    DIVERTICULUM INTESTINAL HAEMORRHAGIC 0/177 (0%) 0 1/175 (0.6%) 1
    GASTRITIS 0/177 (0%) 0 1/175 (0.6%) 1
    GASTROENTERITIS 1/177 (0.6%) 1 0/175 (0%) 0
    GINGIVAL BLEEDING 1/177 (0.6%) 1 0/175 (0%) 0
    HAEMORRHOIDAL HAEMORRHAGE 0/177 (0%) 0 1/175 (0.6%) 1
    INGUINAL HERNIA 0/177 (0%) 0 1/175 (0.6%) 1
    INTESTINAL ISCHAEMIA 1/177 (0.6%) 1 0/175 (0%) 0
    LARGE INTESTINAL PERFORATION 0/177 (0%) 0 1/175 (0.6%) 1
    LOWER GASTROINTESTINAL HAEMORRHAGE 1/177 (0.6%) 1 0/175 (0%) 0
    NAUSEA 0/177 (0%) 0 1/175 (0.6%) 1
    SMALL INTESTINAL OBSTRUCTION 1/177 (0.6%) 1 0/175 (0%) 0
    VOMITING 1/177 (0.6%) 1 1/175 (0.6%) 1
    General disorders
    ASTHENIA 2/177 (1.1%) 2 0/175 (0%) 0
    CATHETER SITE PAIN 0/177 (0%) 0 1/175 (0.6%) 1
    CHEST PAIN 2/177 (1.1%) 2 0/175 (0%) 0
    FATIGUE 0/177 (0%) 0 1/175 (0.6%) 1
    OEDEMA PERIPHERAL 1/177 (0.6%) 1 0/175 (0%) 0
    PYREXIA 7/177 (4%) 8 6/175 (3.4%) 8
    SYSTEMIC INFLAMMATORY RESPONSE SYNDROME 1/177 (0.6%) 1 0/175 (0%) 0
    Hepatobiliary disorders
    HEPATIC FAILURE 0/177 (0%) 0 1/175 (0.6%) 1
    HEPATITIS TOXIC 0/177 (0%) 0 1/175 (0.6%) 1
    Infections and infestations
    ABSCESS INTESTINAL 0/177 (0%) 0 1/175 (0.6%) 1
    ABSCESS 1/177 (0.6%) 1 0/175 (0%) 0
    ANAL INFECTION 0/177 (0%) 0 1/175 (0.6%) 1
    APPENDICEAL ABSCESS 1/177 (0.6%) 1 0/175 (0%) 0
    ARTHRITIS BACTERIAL 1/177 (0.6%) 1 0/175 (0%) 0
    CATHETER RELATED INFECTION 1/177 (0.6%) 1 0/175 (0%) 0
    CELLULITIS 2/177 (1.1%) 2 0/175 (0%) 0
    CELLULITIS STAPHYLOCOCCAL 0/177 (0%) 0 1/175 (0.6%) 1
    CLOSTRIDIUM COLITIS 1/177 (0.6%) 1 0/175 (0%) 0
    ENCEPHALITIS HERPES 0/177 (0%) 0 1/175 (0.6%) 1
    ENTEROBACTER BACTERAEMIA 1/177 (0.6%) 1 0/175 (0%) 0
    HERPES VIRAL INFECTION 1/177 (0.6%) 1 0/175 (0%) 0
    HERPES ZOSTER 1/177 (0.6%) 1 0/175 (0%) 0
    INFECTION 2/177 (1.1%) 2 1/175 (0.6%) 1
    INTERSTITIAL PNEUMONIA 1/177 (0.6%) 1 0/175 (0%) 0
    LOBAR PNEUMONIA 4/177 (2.3%) 6 1/175 (0.6%) 1
    NEUTROPENIC SEPSIS 1/177 (0.6%) 1 0/175 (0%) 0
    OSTEOMYELITIS 1/177 (0.6%) 1 1/175 (0.6%) 1
    PNEUMOCOCCAL BACTERAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    PNEUMOCYSTIS CARINII PNEUMONIA 0/177 (0%) 0 1/175 (0.6%) 1
    PNEUMONIA BACTERIAL 1/177 (0.6%) 1 1/175 (0.6%) 1
    PNEUMONIA CYTOMEGALOVIRAL 0/177 (0%) 0 1/175 (0.6%) 1
    PNEUMONIA FUNGAL 1/177 (0.6%) 1 0/175 (0%) 0
    PNEUMONIA 30/177 (16.9%) 39 15/175 (8.6%) 17
    PNEUMONIA PRIMARY ATYPICAL 1/177 (0.6%) 1 0/175 (0%) 0
    PNEUMONIA STAPHYLOCOCCAL 0/177 (0%) 0 1/175 (0.6%) 1
    PNEUMONIA STREPTOCOCCAL 0/177 (0%) 0 1/175 (0.6%) 1
    SEPSIS 3/177 (1.7%) 3 2/175 (1.1%) 2
    SINUSITIS FUNGAL 1/177 (0.6%) 1 0/175 (0%) 0
    SINUSITIS 2/177 (1.1%) 2 0/175 (0%) 0
    STAPHYLOCOCCAL SEPSIS 0/177 (0%) 0 1/175 (0.6%) 1
    STREPTOCOCCAL BACTERAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    STREPTOCOCCAL SEPSIS 0/177 (0%) 0 1/175 (0.6%) 1
    SUBACUTE ENDOCARDITIS 1/177 (0.6%) 1 0/175 (0%) 0
    TOOTH ABSCESS 1/177 (0.6%) 1 0/175 (0%) 0
    UPPER RESPIRATORY TRACT INFECTION 2/177 (1.1%) 2 1/175 (0.6%) 1
    URINARY TRACT INFECTION 4/177 (2.3%) 5 0/175 (0%) 0
    UROSEPSIS 1/177 (0.6%) 1 0/175 (0%) 0
    VIRAL INFECTION 0/177 (0%) 0 1/175 (0.6%) 1
    Injury, poisoning and procedural complications
    ACETABULUM FRACTURE 1/177 (0.6%) 1 0/175 (0%) 0
    FEMUR FRACTURE 0/177 (0%) 0 1/175 (0.6%) 1
    FIBULA FRACTURE 0/177 (0%) 0 1/175 (0.6%) 1
    HIP FRACTURE 1/177 (0.6%) 1 1/175 (0.6%) 1
    MULTIPLE FRACTURES 1/177 (0.6%) 1 0/175 (0%) 0
    RADIUS FRACTURE 1/177 (0.6%) 1 0/175 (0%) 0
    RIB FRACTURE 2/177 (1.1%) 2 1/175 (0.6%) 1
    SPINAL COMPRESSION FRACTURE 1/177 (0.6%) 1 2/175 (1.1%) 2
    VASCULAR GRAFT OCCLUSION 1/177 (0.6%) 1 0/175 (0%) 0
    WRIST FRACTURE 0/177 (0%) 0 1/175 (0.6%) 1
    Investigations
    BLOOD BILIRUBIN ABNORMAL 1/177 (0.6%) 1 0/175 (0%) 0
    BLOOD CREATININE INCREASED 1/177 (0.6%) 1 0/175 (0%) 0
    HAEMOGLOBIN DECREASED 1/177 (0.6%) 1 0/175 (0%) 0
    INTERNATIONAL NORMALISED RATIO INCREASED 2/177 (1.1%) 2 0/175 (0%) 0
    LIVER FUNCTION TESTS ABNORMAL 1/177 (0.6%) 1 0/175 (0%) 0
    WHITE BLOOD CELL COUNT DECREASED 1/177 (0.6%) 1 0/175 (0%) 0
    Metabolism and nutrition disorders
    DEHYDRATION 7/177 (4%) 9 5/175 (2.9%) 5
    DIABETES WITH HYPEROSMOLARITY 0/177 (0%) 0 2/175 (1.1%) 2
    DIABETIC KETOACIDOSIS 0/177 (0%) 0 1/175 (0.6%) 1
    FLUID OVERLOAD 1/177 (0.6%) 1 0/175 (0%) 0
    HYPERAMMONAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    HYPERCALCAEMIA 2/177 (1.1%) 2 5/175 (2.9%) 5
    HYPERGLYCAEMIA 2/177 (1.1%) 2 4/175 (2.3%) 4
    HYPERKALAEMIA 1/177 (0.6%) 1 0/175 (0%) 0
    HYPOALBUMINAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    HYPOCALCAEMIA 2/177 (1.1%) 2 1/175 (0.6%) 1
    HYPOGLYCAEMIA 2/177 (1.1%) 4 0/175 (0%) 0
    HYPOKALAEMIA 2/177 (1.1%) 2 1/175 (0.6%) 1
    HYPOMAGNESAEMIA 2/177 (1.1%) 2 0/175 (0%) 0
    METABOLIC ACIDOSIS 1/177 (0.6%) 1 0/175 (0%) 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 0/177 (0%) 0 1/175 (0.6%) 1
    BONE PAIN 1/177 (0.6%) 1 0/175 (0%) 0
    CHEST WALL PAIN 1/177 (0.6%) 1 0/175 (0%) 0
    MUSCLE WEAKNESS 1/177 (0.6%) 1 0/175 (0%) 0
    MYALGIA 0/177 (0%) 0 1/175 (0.6%) 1
    MYOPATHY STEROID 0/177 (0%) 0 2/175 (1.1%) 2
    OSTEONECROSIS 0/177 (0%) 0 1/175 (0.6%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BRONCHIOLOALVEOLAR CARCINOMA 1/177 (0.6%) 1 0/175 (0%) 0
    LEUKAEMIA PLASMACYTIC 0/177 (0%) 0 2/175 (1.1%) 2
    LUNG NODULE 0/177 (0%) 0 1/175 (0.6%) 1
    METASTASES TO LIVER 2/177 (1.1%) 2 0/175 (0%) 0
    MYELODYSPLASTIC SYNDROME 2/177 (1.1%) 2 0/175 (0%) 0
    PLASMACYTOMA 0/177 (0%) 0 1/175 (0.6%) 1
    SQUAMOUS CELL CARCINOMA 1/177 (0.6%) 1 0/175 (0%) 0
    SQUAMOUS CELL CARCINOMA OF SKIN 1/177 (0.6%) 1 0/175 (0%) 0
    Nervous system disorders
    CEREBELLAR INFARCTION 1/177 (0.6%) 1 0/175 (0%) 0
    CEREBRAL INFARCTION 0/177 (0%) 0 1/175 (0.6%) 1
    CEREBRAL ISCHAEMIA 1/177 (0.6%) 1 0/175 (0%) 0
    CEREBROVASCULAR ACCIDENT 5/177 (2.8%) 5 1/175 (0.6%) 1
    CONVULSIONS 0/177 (0%) 0 3/175 (1.7%) 3
    DEPRESSED LEVEL OF CONSCIOUSNESS 0/177 (0%) 0 1/175 (0.6%) 1
    DIZZINESS 2/177 (1.1%) 2 0/175 (0%) 0
    INTRACRANIAL HAEMORRHAGE 1/177 (0.6%) 1 0/175 (0%) 0
    INTRACRANIAL VENOUS SINUS THROMBOSIS 1/177 (0.6%) 1 0/175 (0%) 0
    LEUKOENCEPHALOPATHY 1/177 (0.6%) 1 0/175 (0%) 0
    SOMNOLENCE 1/177 (0.6%) 1 0/175 (0%) 0
    SPINAL CORD COMPRESSION 0/177 (0%) 0 2/175 (1.1%) 2
    SUBDURAL HAEMATOMA 1/177 (0.6%) 1 0/175 (0%) 0
    SYNCOPE 3/177 (1.7%) 4 1/175 (0.6%) 1
    TRANSIENT ISCHAEMIC ATTACK 1/177 (0.6%) 1 1/175 (0.6%) 1
    Psychiatric disorders
    ANXIETY 1/177 (0.6%) 1 0/175 (0%) 0
    CONFUSIONAL STATE 1/177 (0.6%) 1 1/175 (0.6%) 1
    DELIRIUM 1/177 (0.6%) 1 0/175 (0%) 0
    DELUSION 1/177 (0.6%) 1 0/175 (0%) 0
    MAJOR DEPRESSIVE DISORDER 1/177 (0.6%) 1 0/175 (0%) 0
    MENTAL STATUS CHANGES 1/177 (0.6%) 1 3/175 (1.7%) 3
    PSYCHOTIC DISORDER 0/177 (0%) 0 2/175 (1.1%) 2
    SUICIDE ATTEMPT 1/177 (0.6%) 1 0/175 (0%) 0
    Renal and urinary disorders
    AZOTAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    FANCONI SYNDROME ACQUIRED 1/177 (0.6%) 1 0/175 (0%) 0
    HAEMATURIA 1/177 (0.6%) 1 1/175 (0.6%) 1
    RENAL FAILURE ACUTE 3/177 (1.7%) 3 2/175 (1.1%) 2
    RENAL FAILURE 3/177 (1.7%) 3 5/175 (2.9%) 5
    RENAL TUBULAR NECROSIS 1/177 (0.6%) 1 0/175 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    ACQUIRED BRONCHOMALACIA 0/177 (0%) 0 1/175 (0.6%) 1
    BRONCHITIS 1/177 (0.6%) 1 1/175 (0.6%) 1
    BRONCHOSPASM 1/177 (0.6%) 1 0/175 (0%) 0
    CHRONIC OBSTRUCTIVE AIRWAYS DISEASE 1/177 (0.6%) 1 2/175 (1.1%) 2
    COUGH 0/177 (0%) 0 1/175 (0.6%) 1
    DYSPNOEA EXACERBATED 0/177 (0%) 0 1/175 (0.6%) 1
    DYSPNOEA 4/177 (2.3%) 4 1/175 (0.6%) 1
    EMPHYSEMATOUS BULLA 0/177 (0%) 0 1/175 (0.6%) 1
    EPISTAXIS 1/177 (0.6%) 1 1/175 (0.6%) 1
    HYPOXIA 2/177 (1.1%) 24 1/175 (0.6%) 1
    PLEURAL EFFUSION 1/177 (0.6%) 1 1/175 (0.6%) 1
    PULMONARY EMBOLISM 6/177 (3.4%) 6 1/175 (0.6%) 1
    RESPIRATORY FAILURE 1/177 (0.6%) 1 2/175 (1.1%) 2
    Skin and subcutaneous tissue disorders
    DERMATITIS 0/177 (0%) 0 1/175 (0.6%) 1
    RASH 1/177 (0.6%) 1 0/175 (0%) 0
    SKIN DESQUAMATION 1/177 (0.6%) 1 0/175 (0%) 0
    SKIN DISCOLOURATION 1/177 (0.6%) 1 0/175 (0%) 0
    Vascular disorders
    AORTIC STENOSIS 1/177 (0.6%) 1 0/175 (0%) 0
    ARTERIAL THROMBOSIS 1/177 (0.6%) 1 0/175 (0%) 0
    DEEP VEIN THROMBOSIS 18/177 (10.2%) 18 6/175 (3.4%) 6
    HYPERTENSION 1/177 (0.6%) 1 1/175 (0.6%) 1
    HYPERTENSIVE CRISIS 1/177 (0.6%) 1 0/175 (0%) 0
    HYPOTENSION 0/177 (0%) 0 2/175 (1.1%) 2
    ORTHOSTATIC HYPOTENSION 1/177 (0.6%) 1 0/175 (0%) 0
    PERIPHERAL ISCHAEMIA 1/177 (0.6%) 1 0/175 (0%) 0
    PERIPHERAL ISCHAEMIA 0/177 (0%) 0 1/175 (0.6%) 1
    SUPERIOR VENA CAVAL OCCLUSION 1/177 (0.6%) 1 0/175 (0%) 0
    Other (Not Including Serious) Adverse Events
    CC-5013/Dex Placebo/Dex
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 177/177 (100%) 175/175 (100%)
    Blood and lymphatic system disorders
    ANAEMIA 72/177 (40.7%) 139 37/175 (21.1%) 44
    LEUKOPENIA 15/177 (8.5%) 20 3/175 (1.7%) 3
    NEUTROPENIA 87/177 (49.2%) 348 12/175 (6.9%) 22
    THROMBOCYTOPENIA 45/177 (25.4%) 83 19/175 (10.9%) 28
    Endocrine disorders
    CUSHINGOID 12/177 (6.8%) 13 13/175 (7.4%) 13
    Eye disorders
    CATARACT 9/177 (5.1%) 10 1/175 (0.6%) 1
    CATARACT UNILATERAL 10/177 (5.6%) 15 2/175 (1.1%) 3
    VISION BLURRED 50/177 (28.2%) 79 30/175 (17.1%) 56
    Gastrointestinal disorders
    ABDOMINAL DISTENSION 11/177 (6.2%) 12 15/175 (8.6%) 18
    ABDOMINAL PAIN 20/177 (11.3%) 27 12/175 (6.9%) 15
    ABDOMINAL PAIN UPPER 11/177 (6.2%) 13 10/175 (5.7%) 12
    CONSTIPATION 74/177 (41.8%) 99 35/175 (20%) 43
    DIARRHOEA 85/177 (48%) 174 53/175 (30.3%) 85
    DRY MOUTH 17/177 (9.6%) 18 8/175 (4.6%) 10
    DYSPEPSIA 37/177 (20.9%) 41 28/175 (16%) 37
    FLATULENCE 16/177 (9%) 18 9/175 (5.1%) 10
    GASTROOESOPHAGEAL REFLUX DISEASE 10/177 (5.6%) 13 4/175 (2.3%) 5
    LOOSE STOOLS 13/177 (7.3%) 14 10/175 (5.7%) 13
    NAUSEA 58/177 (32.8%) 90 55/175 (31.4%) 79
    ORAL PAIN 10/177 (5.6%) 12 1/175 (0.6%) 1
    STOMATITIS 15/177 (8.5%) 23 14/175 (8%) 15
    TOOTHACHE 10/177 (5.6%) 11 5/175 (2.9%) 5
    VOMITING 26/177 (14.7%) 32 22/175 (12.6%) 24
    General disorders
    ASTHENIA 43/177 (24.3%) 59 47/175 (26.9%) 66
    CHEST PAIN 22/177 (12.4%) 34 15/175 (8.6%) 24
    FATIGUE 114/177 (64.4%) 191 105/175 (60%) 164
    INFLUENZA LIKE ILLNESS 10/177 (5.6%) 11 3/175 (1.7%) 5
    LETHARGY 11/177 (6.2%) 12 4/175 (2.3%) 4
    OEDEMA 15/177 (8.5%) 22 18/175 (10.3%) 22
    OEDEMA PERIPHERAL 58/177 (32.8%) 87 42/175 (24%) 54
    PAIN 20/177 (11.3%) 23 19/175 (10.9%) 25
    PYREXIA 54/177 (30.5%) 85 35/175 (20%) 48
    RIGORS 10/177 (5.6%) 15 14/175 (8%) 16
    Infections and infestations
    CELLULITIS 10/177 (5.6%) 11 3/175 (1.7%) 3
    HERPES SIMPLEX 15/177 (8.5%) 22 6/175 (3.4%) 6
    ORAL CANDIDIASIS 14/177 (7.9%) 18 10/175 (5.7%) 11
    PNEUMONIA 23/177 (13%) 31 4/175 (2.3%) 4
    SINUSITIS 26/177 (14.7%) 41 11/175 (6.3%) 14
    URINARY TRACT INFECTION 18/177 (10.2%) 31 7/175 (4%) 13
    Investigations
    BLOOD CREATININE INCREASED 9/177 (5.1%) 13 6/175 (3.4%) 6
    LIVER FUNCTION TESTS ABNORMAL 10/177 (5.6%) 11 3/175 (1.7%) 3
    WEIGHT DECREASED 20/177 (11.3%) 24 8/175 (4.6%) 8
    Metabolism and nutrition disorders
    ANOREXIA 35/177 (19.8%) 39 22/175 (12.6%) 23
    APPETITE DECREASED 21/177 (11.9%) 25 12/175 (6.9%) 14
    DEHYDRATION 21/177 (11.9%) 26 9/175 (5.1%) 10
    FLUID RETENTION 9/177 (5.1%) 9 2/175 (1.1%) 3
    HYPERGLYCAEMIA 37/177 (20.9%) 62 24/175 (13.7%) 28
    HYPERKALAEMIA 10/177 (5.6%) 11 2/175 (1.1%) 2
    HYPOCALCAEMIA 17/177 (9.6%) 22 4/175 (2.3%) 5
    HYPOKALAEMIA 34/177 (19.2%) 91 12/175 (6.9%) 17
    HYPOMAGNESAEMIA 21/177 (11.9%) 34 8/175 (4.6%) 8
    HYPOPHOSPHATAEMIA 9/177 (5.1%) 11 5/175 (2.9%) 5
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 41/177 (23.2%) 63 35/175 (20%) 51
    BACK PAIN 57/177 (32.2%) 71 38/175 (21.7%) 40
    BONE PAIN 20/177 (11.3%) 31 15/175 (8.6%) 25
    CHEST WALL PAIN 17/177 (9.6%) 18 9/175 (5.1%) 9
    JOINT SWELLING 9/177 (5.1%) 11 2/175 (1.1%) 2
    MUSCLE CRAMP 69/177 (39%) 120 41/175 (23.4%) 61
    MUSCLE SPASMS 9/177 (5.1%) 11 5/175 (2.9%) 6
    MUSCLE WEAKNESS 27/177 (15.3%) 37 29/175 (16.6%) 31
    MUSCULOSKELETAL STIFFNESS 9/177 (5.1%) 9 6/175 (3.4%) 7
    MYALGIA 21/177 (11.9%) 22 22/175 (12.6%) 26
    PAIN IN LIMB 28/177 (15.8%) 38 13/175 (7.4%) 23
    PERIPHERAL SWELLING 18/177 (10.2%) 21 4/175 (2.3%) 5
    Nervous system disorders
    AGEUSIA 10/177 (5.6%) 13 7/175 (4%) 7
    BALANCE IMPAIRED 10/177 (5.6%) 11 3/175 (1.7%) 3
    DIZZINESS 51/177 (28.8%) 102 43/175 (24.6%) 54
    DYSGEUSIA 34/177 (19.2%) 37 19/175 (10.9%) 23
    HEADACHE 56/177 (31.6%) 79 54/175 (30.9%) 66
    HYPERTENSION 17/177 (9.6%) 17 11/175 (6.3%) 15
    NEUROPATHY 21/177 (11.9%) 25 12/175 (6.9%) 13
    PARAESTHESIA 24/177 (13.6%) 31 18/175 (10.3%) 23
    PERIPHERAL NEUROPATHY 27/177 (15.3%) 33 19/175 (10.9%) 23
    SOMNOLENCE 10/177 (5.6%) 10 7/175 (4%) 8
    SYNCOPE 9/177 (5.1%) 16 1/175 (0.6%) 1
    TREMOR 36/177 (20.3%) 44 12/175 (6.9%) 15
    Psychiatric disorders
    ANXIETY 32/177 (18.1%) 38 20/175 (11.4%) 22
    CONFUSIONAL STATE 22/177 (12.4%) 25 14/175 (8%) 16
    DEPRESSION 29/177 (16.4%) 31 19/175 (10.9%) 19
    INSOMNIA 84/177 (47.5%) 99 70/175 (40%) 84
    IRRITABILITY 20/177 (11.3%) 21 11/175 (6.3%) 11
    MOOD ALTERATION 5/177 (2.8%) 6 17/175 (9.7%) 17
    MOOD SWINGS 9/177 (5.1%) 9 4/175 (2.3%) 4
    Renal and urinary disorders
    NOCTURIA 6/177 (3.4%) 6 10/175 (5.7%) 11
    URINARY FREQUENCY 11/177 (6.2%) 13 7/175 (4%) 8
    Respiratory, thoracic and mediastinal disorders
    BRONCHITIS 19/177 (10.7%) 24 3/175 (1.7%) 7
    COUGH 53/177 (29.9%) 91 48/175 (27.4%) 53
    DYSPNOEA EXERTIONAL 14/177 (7.9%) 16 12/175 (6.9%) 12
    DYSPNOEA 51/177 (28.8%) 64 39/175 (22.3%) 47
    EPISTAXIS 16/177 (9%) 21 11/175 (6.3%) 12
    HICCUPS 11/177 (6.2%) 26 9/175 (5.1%) 9
    HOARSENESS 19/177 (10.7%) 20 14/175 (8%) 14
    NASAL CONGESTION 20/177 (11.3%) 20 7/175 (4%) 8
    NASOPHARYNGITIS 39/177 (22%) 82 11/175 (6.3%) 13
    PHARYNGITIS 33/177 (18.6%) 55 18/175 (10.3%) 22
    PRODUCTIVE COUGH 12/177 (6.8%) 13 7/175 (4%) 7
    RHINORRHOEA 9/177 (5.1%) 12 5/175 (2.9%) 6
    UPPER RESPIRATORY TRACT INFECTION 63/177 (35.6%) 123 39/175 (22.3%) 59
    Skin and subcutaneous tissue disorders
    CONTUSION 20/177 (11.3%) 23 13/175 (7.4%) 15
    DRY SKIN 19/177 (10.7%) 24 10/175 (5.7%) 13
    ECCHYMOSIS 9/177 (5.1%) 9 1/175 (0.6%) 1
    ERYTHEMA 10/177 (5.6%) 12 6/175 (3.4%) 6
    FACE OEDEMA 13/177 (7.3%) 15 13/175 (7.4%) 13
    NIGHT SWEATS 16/177 (9%) 20 13/175 (7.4%) 16
    PRURITUS 20/177 (11.3%) 30 10/175 (5.7%) 11
    RASH 55/177 (31.1%) 83 28/175 (16%) 30
    SWEATING INCREASED 19/177 (10.7%) 21 10/175 (5.7%) 11
    Vascular disorders
    DEEP VEIN THROMBOSIS 10/177 (5.6%) 10 0/175 (0%) 0
    FLUSHING 12/177 (6.8%) 13 12/175 (6.9%) 12
    HYPOTENSION 20/177 (11.3%) 21 5/175 (2.9%) 5

    Limitations/Caveats

    Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The investigator shall have the right to publish and/or present the clinical data generated from the study provided that such Investigator shall furnish sponsor with a copy of the proposed publication or presentation at least 60 days in advance of submission, delete any confidential information, and delay submission for up to 90 days to permit the preparation and filing of appropriate intellectual property applications.

    Results Point of Contact

    Name/Title Robert Knight, M.D.
    Organization Celgene Corporation
    Phone 908-673-9749
    Email rknight@celgene.com
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00056160
    Other Study ID Numbers:
    • CC-5013-MM-009
    First Posted:
    Mar 7, 2003
    Last Update Posted:
    Oct 19, 2017
    Last Verified:
    Sep 1, 2017