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Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01441973
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : January 29, 2016
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoldering Multiple Myeloma
Intervention Biological: Elotuzumab (BMS-901608; HuLuc63)
Enrollment 41
Recruitment Details  
Pre-assignment Details The study enrolled a total of 41 participants, and 31 received treatment. The 10 participants enrolled who did not receive treatment failed to meet the inclusion criteria.
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg
Hide Arm/Group Description Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles. Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
Period Title: Overall Study
Started 15 16
Completed 0 [1] 0 [1]
Not Completed 15 16
Reason Not Completed
Disease progression             8             6
Adverse event unrelated to study drug             3             2
Participant request to discontinue             1             1
Poor compliance/noncompliance             0             1
Administrative reason by sponsor             3             5
Participant withdrew consent             0             1
[1]
Still receiving treatment
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Total
Hide Arm/Group Description Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles. Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles. Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
59.0  (9.75) 59.3  (9.37) 59.2  (9.40)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Younger than 65 years 10 13 23
65 years and older to younger than 75 years 5 2 7
75 years and older 0 1 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
5
  33.3%
9
  56.3%
14
  45.2%
Male
10
  66.7%
7
  43.8%
17
  54.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Hispanic or Latino
0
   0.0%
1
   6.3%
1
   3.2%
Not Hispanic or Latino
15
 100.0%
15
  93.8%
30
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
White 14 15 29
Black or African American 1 1 2
Serum monoclonal (M) protein  
Mean (Standard Deviation)
Unit of measure:  g/L
Number Analyzed 15 participants 16 participants 31 participants
29.5  (15.19) 21.9  (11.46) 25.6  (13.72)
Urine M protein  
Mean (Standard Deviation)
Unit of measure:  G/day
Number Analyzed 15 participants 16 participants 31 participants
0.208  (0.6199) 0.094  (0.2131) 0.149  (0.4532)
Time from diagnosis to enrollment  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 15 participants 16 participants 31 participants
31.75  (37.572) 36.81  (35.103) 34.37  (35.798)
1.Primary Outcome
Title Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
Hide Description Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)
Time Frame From day of last patient, first dose to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 13 12 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % chg from BL in M pro/% chg CD56^dim cs
-2.562
(-5.439 to 0.316)
2.464
(0.086 to 4.842)
0.274
(-1.722 to 2.270)
2.Secondary Outcome
Title Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Time Frame From day of last patient, first dose to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 15 16 31
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0
SAEs 8 7 15
AEs leading to discontinuation 4 2 6
Infusion reactions 4 1 5
3.Secondary Outcome
Title Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
Hide Description Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.
Time Frame From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 15 16 22
Measure Type: Number
Unit of Measure: Participants
Lymphocytes 2 1 3
Hyponatremia 1 1 2
Hyperkalemia 0 1 1
Hyperglycemia 1 2 3
4.Secondary Outcome
Title Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate
Hide Description All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.
Time Frame cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 15 16 31
Measure Type: Number
Unit of Measure: Participants
0 0 0
5.Secondary Outcome
Title Progression Free Survival (PFS) Rate
Hide Description The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort
Time Frame Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 15 16 31
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Probability of Progression Free Survival
0.71
(0.45 to 0.86)
0.54
(0.31 to 0.72)
0.62
(0.45 to 0.75)
6.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR is defined as the number of participants with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour
Time Frame From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Elotuzumab, 20 mg/kg Elotuzumab, 10 mg/kg Elotuzumab, All Dosages
Hide Arm/Group Description:
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
Overall Number of Participants Analyzed 15 16 31
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
13.3
(2.4 to 36.3)
6.3
(0.3 to 26.4)
9.7
(2.7 to 23.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Elotuzumab(E) : 10 mg/kg/Dose Elotuzumab(E) : 20 mg/kg/Dose
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Elotuzumab(E) : 10 mg/kg/Dose Elotuzumab(E) : 20 mg/kg/Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Elotuzumab(E) : 10 mg/kg/Dose Elotuzumab(E) : 20 mg/kg/Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   7/16 (43.75%)   8/15 (53.33%) 
Ear and labyrinth disorders     
Vertigo  1  1/16 (6.25%)  1/15 (6.67%) 
General disorders     
Asthenia  1  0/16 (0.00%)  1/15 (6.67%) 
Non-cardiac chest pain  1  0/16 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Arthritis bacterial  1  0/16 (0.00%)  1/15 (6.67%) 
Influenza  1  0/16 (0.00%)  1/15 (6.67%) 
Pneumonia  1  1/16 (6.25%)  1/15 (6.67%) 
Rectal abscess  1  1/16 (6.25%)  0/15 (0.00%) 
Upper respiratory tract infection  1  0/16 (0.00%)  1/15 (6.67%) 
Urinary tract infection  1  0/16 (0.00%)  1/15 (6.67%) 
Urosepsis  1  0/16 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/16 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders     
Dehydration  1  1/16 (6.25%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pathological fracture  1  0/16 (0.00%)  1/15 (6.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial cancer  1  1/16 (6.25%)  0/15 (0.00%) 
Prostate cancer  1  1/16 (6.25%)  0/15 (0.00%) 
Renal cell carcinoma  1  1/16 (6.25%)  0/15 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  0/16 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Acute kidney injury  1  1/16 (6.25%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/16 (6.25%)  0/15 (0.00%) 
Respiratory failure  1  1/16 (6.25%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Elotuzumab(E) : 10 mg/kg/Dose Elotuzumab(E) : 20 mg/kg/Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   15/15 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  5/16 (31.25%)  2/15 (13.33%) 
Increased tendency to bruise  1  2/16 (12.50%)  0/15 (0.00%) 
Neutropenia  1  2/16 (12.50%)  0/15 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  2/16 (12.50%)  1/15 (6.67%) 
Cardiac failure congestive  1  1/16 (6.25%)  0/15 (0.00%) 
Coronary artery disease  1  1/16 (6.25%)  0/15 (0.00%) 
Palpitations  1  1/16 (6.25%)  1/15 (6.67%) 
Pericardial effusion  1  1/16 (6.25%)  0/15 (0.00%) 
Tachycardia  1  1/16 (6.25%)  1/15 (6.67%) 
Ear and labyrinth disorders     
Cerumen impaction  1  2/16 (12.50%)  0/15 (0.00%) 
Ear discomfort  1  1/16 (6.25%)  0/15 (0.00%) 
Ear pain  1  1/16 (6.25%)  1/15 (6.67%) 
Tinnitus  1  1/16 (6.25%)  0/15 (0.00%) 
Endocrine disorders     
Cushingoid  1  0/16 (0.00%)  1/15 (6.67%) 
Eye disorders     
Blepharitis  1  0/16 (0.00%)  1/15 (6.67%) 
Cataract  1  1/16 (6.25%)  1/15 (6.67%) 
Dry eye  1  1/16 (6.25%)  0/15 (0.00%) 
Eye discharge  1  1/16 (6.25%)  0/15 (0.00%) 
Eye irritation  1  2/16 (12.50%)  0/15 (0.00%) 
Optic ischaemic neuropathy  1  0/16 (0.00%)  1/15 (6.67%) 
Photopsia  1  1/16 (6.25%)  1/15 (6.67%) 
Retinal detachment  1  1/16 (6.25%)  0/15 (0.00%) 
Retinal disorder  1  1/16 (6.25%)  0/15 (0.00%) 
Vision blurred  1  0/16 (0.00%)  1/15 (6.67%) 
Vitreous floaters  1  1/16 (6.25%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/16 (12.50%)  0/15 (0.00%) 
Abdominal distension  1  0/16 (0.00%)  2/15 (13.33%) 
Abdominal pain  1  1/16 (6.25%)  0/15 (0.00%) 
Abdominal pain lower  1  1/16 (6.25%)  0/15 (0.00%) 
Abdominal pain upper  1  1/16 (6.25%)  0/15 (0.00%) 
Aphthous ulcer  1  0/16 (0.00%)  1/15 (6.67%) 
Constipation  1  5/16 (31.25%)  4/15 (26.67%) 
Dental discomfort  1  0/16 (0.00%)  1/15 (6.67%) 
Diarrhoea  1  5/16 (31.25%)  4/15 (26.67%) 
Dyspepsia  1  3/16 (18.75%)  1/15 (6.67%) 
Dysphagia  1  0/16 (0.00%)  1/15 (6.67%) 
Gastrooesophageal reflux disease  1  1/16 (6.25%)  2/15 (13.33%) 
Gingival pain  1  1/16 (6.25%)  0/15 (0.00%) 
Haemorrhoidal haemorrhage  1  1/16 (6.25%)  0/15 (0.00%) 
Haemorrhoids  1  0/16 (0.00%)  1/15 (6.67%) 
Irritable bowel syndrome  1  0/16 (0.00%)  1/15 (6.67%) 
Large intestine polyp  1  1/16 (6.25%)  0/15 (0.00%) 
Loose tooth  1  0/16 (0.00%)  1/15 (6.67%) 
Nausea  1  3/16 (18.75%)  3/15 (20.00%) 
Oesophageal spasm  1  0/16 (0.00%)  1/15 (6.67%) 
Oral disorder  1  1/16 (6.25%)  0/15 (0.00%) 
Palatal disorder  1  1/16 (6.25%)  0/15 (0.00%) 
Paraesthesia oral  1  0/16 (0.00%)  1/15 (6.67%) 
Retching  1  0/16 (0.00%)  1/15 (6.67%) 
Sensitivity of teeth  1  0/16 (0.00%)  1/15 (6.67%) 
Tongue blistering  1  1/16 (6.25%)  0/15 (0.00%) 
Tongue coated  1  0/16 (0.00%)  1/15 (6.67%) 
Tooth disorder  1  0/16 (0.00%)  2/15 (13.33%) 
Toothache  1  1/16 (6.25%)  0/15 (0.00%) 
Vomiting  1  0/16 (0.00%)  1/15 (6.67%) 
General disorders     
Asthenia  1  0/16 (0.00%)  1/15 (6.67%) 
Catheter site pain  1  0/16 (0.00%)  1/15 (6.67%) 
Chest pain  1  0/16 (0.00%)  1/15 (6.67%) 
Chills  1  2/16 (12.50%)  4/15 (26.67%) 
Chronic fatigue syndrome  1  0/16 (0.00%)  1/15 (6.67%) 
Cyst  1  1/16 (6.25%)  0/15 (0.00%) 
Drug withdrawal syndrome  1  0/16 (0.00%)  1/15 (6.67%) 
Fatigue  1  10/16 (62.50%)  8/15 (53.33%) 
Feeling cold  1  2/16 (12.50%)  0/15 (0.00%) 
Feeling jittery  1  0/16 (0.00%)  1/15 (6.67%) 
Influenza like illness  1  1/16 (6.25%)  0/15 (0.00%) 
Malaise  1  1/16 (6.25%)  3/15 (20.00%) 
Non-cardiac chest pain  1  1/16 (6.25%)  0/15 (0.00%) 
Oedema  1  1/16 (6.25%)  0/15 (0.00%) 
Oedema peripheral  1  4/16 (25.00%)  2/15 (13.33%) 
Pain  1  2/16 (12.50%)  1/15 (6.67%) 
Peripheral swelling  1  1/16 (6.25%)  1/15 (6.67%) 
Pyrexia  1  3/16 (18.75%)  5/15 (33.33%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/16 (6.25%)  0/15 (0.00%) 
Ocular icterus  1  1/16 (6.25%)  1/15 (6.67%) 
Immune system disorders     
Hypersensitivity  1  0/16 (0.00%)  1/15 (6.67%) 
Seasonal allergy  1  1/16 (6.25%)  2/15 (13.33%) 
Infections and infestations     
Appendicitis  1  0/16 (0.00%)  1/15 (6.67%) 
Bronchitis  1  1/16 (6.25%)  0/15 (0.00%) 
Candida infection  1  0/16 (0.00%)  1/15 (6.67%) 
Ear infection  1  0/16 (0.00%)  1/15 (6.67%) 
Ear infection viral  1  0/16 (0.00%)  1/15 (6.67%) 
Epididymitis  1  0/16 (0.00%)  1/15 (6.67%) 
Febrile infection  1  1/16 (6.25%)  0/15 (0.00%) 
Fungal infection  1  0/16 (0.00%)  1/15 (6.67%) 
Gastroenteritis viral  1  2/16 (12.50%)  1/15 (6.67%) 
Gastrointestinal viral infection  1  0/16 (0.00%)  1/15 (6.67%) 
Gingivitis  1  2/16 (12.50%)  1/15 (6.67%) 
Herpes zoster  1  0/16 (0.00%)  3/15 (20.00%) 
Hordeolum  1  0/16 (0.00%)  1/15 (6.67%) 
Influenza  1  1/16 (6.25%)  0/15 (0.00%) 
Lyme disease  1  1/16 (6.25%)  0/15 (0.00%) 
Oral candidiasis  1  1/16 (6.25%)  3/15 (20.00%) 
Pharyngitis  1  0/16 (0.00%)  1/15 (6.67%) 
Pneumonia  1  2/16 (12.50%)  0/15 (0.00%) 
Purulence  1  1/16 (6.25%)  0/15 (0.00%) 
Rhinitis  1  5/16 (31.25%)  2/15 (13.33%) 
Sinusitis  1  3/16 (18.75%)  1/15 (6.67%) 
Sinusitis bacterial  1  1/16 (6.25%)  0/15 (0.00%) 
Tonsillitis  1  0/16 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  1  12/16 (75.00%)  9/15 (60.00%) 
Urinary tract infection  1  0/16 (0.00%)  1/15 (6.67%) 
Vaginal infection  1  0/16 (0.00%)  1/15 (6.67%) 
Viral infection  1  0/16 (0.00%)  1/15 (6.67%) 
Viral upper respiratory tract infection  1  2/16 (12.50%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Burns second degree  1  1/16 (6.25%)  0/15 (0.00%) 
Contusion  1  0/16 (0.00%)  2/15 (13.33%) 
Fall  1  2/16 (12.50%)  2/15 (13.33%) 
Foot fracture  1  1/16 (6.25%)  1/15 (6.67%) 
Hand fracture  1  1/16 (6.25%)  0/15 (0.00%) 
Infusion related reaction  1  0/16 (0.00%)  2/15 (13.33%) 
Laceration  1  1/16 (6.25%)  1/15 (6.67%) 
Ligament sprain  1  1/16 (6.25%)  0/15 (0.00%) 
Limb fracture  1  1/16 (6.25%)  0/15 (0.00%) 
Muscle strain  1  2/16 (12.50%)  0/15 (0.00%) 
Post procedural diarrhoea  1  1/16 (6.25%)  0/15 (0.00%) 
Post procedural haemorrhage  1  1/16 (6.25%)  0/15 (0.00%) 
Post procedural swelling  1  1/16 (6.25%)  0/15 (0.00%) 
Tendon injury  1  1/16 (6.25%)  0/15 (0.00%) 
Wrist fracture  1  0/16 (0.00%)  1/15 (6.67%) 
Investigations     
Activated partial thromboplastin time prolonged  1  0/16 (0.00%)  1/15 (6.67%) 
Alanine aminotransferase increased  1  0/16 (0.00%)  1/15 (6.67%) 
Blood alkaline phosphatase increased  1  1/16 (6.25%)  0/15 (0.00%) 
Blood calcium increased  1  1/16 (6.25%)  0/15 (0.00%) 
Blood cholesterol increased  1  1/16 (6.25%)  0/15 (0.00%) 
Blood potassium increased  1  1/16 (6.25%)  0/15 (0.00%) 
Cardiac murmur  1  1/16 (6.25%)  1/15 (6.67%) 
Eosinophil count increased  1  1/16 (6.25%)  0/15 (0.00%) 
Haemoglobin decreased  1  1/16 (6.25%)  0/15 (0.00%) 
Heart rate decreased  1  1/16 (6.25%)  0/15 (0.00%) 
International normalised ratio increased  1  0/16 (0.00%)  1/15 (6.67%) 
Neutrophil count increased  1  1/16 (6.25%)  0/15 (0.00%) 
Protein total increased  1  1/16 (6.25%)  0/15 (0.00%) 
Protein urine present  1  1/16 (6.25%)  0/15 (0.00%) 
Red blood cell count decreased  1  1/16 (6.25%)  0/15 (0.00%) 
Weight decreased  1  0/16 (0.00%)  1/15 (6.67%) 
Weight increased  1  1/16 (6.25%)  1/15 (6.67%) 
White blood cell count decreased  1  0/16 (0.00%)  1/15 (6.67%) 
White blood cell count increased  1  0/16 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/16 (12.50%)  2/15 (13.33%) 
Hyperglycaemia  1  5/16 (31.25%)  2/15 (13.33%) 
Hyperkalaemia  1  1/16 (6.25%)  0/15 (0.00%) 
Hypocalcaemia  1  1/16 (6.25%)  2/15 (13.33%) 
Hypoglycaemia  1  1/16 (6.25%)  0/15 (0.00%) 
Hyponatraemia  1  3/16 (18.75%)  3/15 (20.00%) 
Hypophosphataemia  1  1/16 (6.25%)  0/15 (0.00%) 
Vitamin d deficiency  1  1/16 (6.25%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/16 (37.50%)  6/15 (40.00%) 
Arthritis  1  2/16 (12.50%)  0/15 (0.00%) 
Back pain  1  9/16 (56.25%)  2/15 (13.33%) 
Bone pain  1  1/16 (6.25%)  0/15 (0.00%) 
Exostosis  1  1/16 (6.25%)  0/15 (0.00%) 
Foot deformity  1  1/16 (6.25%)  0/15 (0.00%) 
Joint swelling  1  2/16 (12.50%)  2/15 (13.33%) 
Muscle spasms  1  1/16 (6.25%)  1/15 (6.67%) 
Muscle tightness  1  1/16 (6.25%)  1/15 (6.67%) 
Muscular weakness  1  0/16 (0.00%)  2/15 (13.33%) 
Musculoskeletal chest pain  1  1/16 (6.25%)  1/15 (6.67%) 
Musculoskeletal pain  1  2/16 (12.50%)  3/15 (20.00%) 
Musculoskeletal stiffness  1  1/16 (6.25%)  0/15 (0.00%) 
Myalgia  1  0/16 (0.00%)  2/15 (13.33%) 
Neck pain  1  1/16 (6.25%)  2/15 (13.33%) 
Osteoarthritis  1  1/16 (6.25%)  1/15 (6.67%) 
Pain in extremity  1  4/16 (25.00%)  4/15 (26.67%) 
Rotator cuff syndrome  1  0/16 (0.00%)  1/15 (6.67%) 
Scoliosis  1  1/16 (6.25%)  0/15 (0.00%) 
Spinal column stenosis  1  1/16 (6.25%)  0/15 (0.00%) 
Tendon disorder  1  1/16 (6.25%)  0/15 (0.00%) 
Tendon pain  1  1/16 (6.25%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acrochordon  1  0/16 (0.00%)  1/15 (6.67%) 
Endometrial cancer  1  1/16 (6.25%)  0/15 (0.00%) 
Seborrhoeic keratosis  1  0/16 (0.00%)  1/15 (6.67%) 
Skin papilloma  1  1/16 (6.25%)  0/15 (0.00%) 
Squamous cell carcinoma  1  1/16 (6.25%)  0/15 (0.00%) 
Nervous system disorders     
Dizziness  1  3/16 (18.75%)  4/15 (26.67%) 
Dysgeusia  1  0/16 (0.00%)  1/15 (6.67%) 
Headache  1  7/16 (43.75%)  3/15 (20.00%) 
Hypoaesthesia  1  0/16 (0.00%)  2/15 (13.33%) 
Memory impairment  1  0/16 (0.00%)  2/15 (13.33%) 
Migraine  1  1/16 (6.25%)  1/15 (6.67%) 
Muscle tone disorder  1  1/16 (6.25%)  0/15 (0.00%) 
Nerve compression  1  1/16 (6.25%)  0/15 (0.00%) 
Neuropathy peripheral  1  1/16 (6.25%)  3/15 (20.00%) 
Paraesthesia  1  4/16 (25.00%)  1/15 (6.67%) 
Sciatica  1  1/16 (6.25%)  0/15 (0.00%) 
Sinus headache  1  1/16 (6.25%)  0/15 (0.00%) 
Somnolence  1  1/16 (6.25%)  0/15 (0.00%) 
Syncope  1  0/16 (0.00%)  1/15 (6.67%) 
Tremor  1  2/16 (12.50%)  0/15 (0.00%) 
Psychiatric disorders     
Agitation  1  1/16 (6.25%)  1/15 (6.67%) 
Anxiety  1  1/16 (6.25%)  1/15 (6.67%) 
Insomnia  1  7/16 (43.75%)  3/15 (20.00%) 
Restlessness  1  0/16 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders     
Acute kidney injury  1  1/16 (6.25%)  0/15 (0.00%) 
Dysuria  1  1/16 (6.25%)  0/15 (0.00%) 
Incontinence  1  0/16 (0.00%)  1/15 (6.67%) 
Micturition urgency  1  1/16 (6.25%)  0/15 (0.00%) 
Nocturia  1  0/16 (0.00%)  1/15 (6.67%) 
Pollakiuria  1  1/16 (6.25%)  0/15 (0.00%) 
Urinary incontinence  1  1/16 (6.25%)  1/15 (6.67%) 
Reproductive system and breast disorders     
Breast pain  1  1/16 (6.25%)  0/15 (0.00%) 
Testicular disorder  1  0/16 (0.00%)  1/15 (6.67%) 
Vaginal haemorrhage  1  1/16 (6.25%)  2/15 (13.33%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/16 (6.25%)  0/15 (0.00%) 
Cough  1  3/16 (18.75%)  2/15 (13.33%) 
Dysphonia  1  1/16 (6.25%)  0/15 (0.00%) 
Dyspnoea  1  1/16 (6.25%)  1/15 (6.67%) 
Epistaxis  1  2/16 (12.50%)  2/15 (13.33%) 
Nasal congestion  1  5/16 (31.25%)  1/15 (6.67%) 
Oropharyngeal pain  1  3/16 (18.75%)  3/15 (20.00%) 
Paranasal sinus discomfort  1  1/16 (6.25%)  0/15 (0.00%) 
Pharyngeal erythema  1  1/16 (6.25%)  0/15 (0.00%) 
Pleural effusion  1  1/16 (6.25%)  0/15 (0.00%) 
Productive cough  1  4/16 (25.00%)  1/15 (6.67%) 
Respiratory tract congestion  1  1/16 (6.25%)  1/15 (6.67%) 
Rhinorrhoea  1  1/16 (6.25%)  1/15 (6.67%) 
Sinus congestion  1  0/16 (0.00%)  1/15 (6.67%) 
Sinus pain  1  1/16 (6.25%)  1/15 (6.67%) 
Throat tightness  1  0/16 (0.00%)  1/15 (6.67%) 
Upper-airway cough syndrome  1  2/16 (12.50%)  0/15 (0.00%) 
Wheezing  1  4/16 (25.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/16 (6.25%)  1/15 (6.67%) 
Dermatitis acneiform  1  0/16 (0.00%)  1/15 (6.67%) 
Drug eruption  1  0/16 (0.00%)  1/15 (6.67%) 
Dry skin  1  1/16 (6.25%)  0/15 (0.00%) 
Ecchymosis  1  1/16 (6.25%)  0/15 (0.00%) 
Erythema  1  0/16 (0.00%)  2/15 (13.33%) 
Hyperhidrosis  1  1/16 (6.25%)  2/15 (13.33%) 
Ingrown hair  1  1/16 (6.25%)  0/15 (0.00%) 
Night sweats  1  1/16 (6.25%)  0/15 (0.00%) 
Pruritus  1  0/16 (0.00%)  1/15 (6.67%) 
Rash  1  2/16 (12.50%)  1/15 (6.67%) 
Rash maculo-papular  1  2/16 (12.50%)  0/15 (0.00%) 
Rash pruritic  1  1/16 (6.25%)  0/15 (0.00%) 
Skin exfoliation  1  0/16 (0.00%)  1/15 (6.67%) 
Skin fissures  1  1/16 (6.25%)  0/15 (0.00%) 
Skin hyperpigmentation  1  1/16 (6.25%)  0/15 (0.00%) 
Skin induration  1  1/16 (6.25%)  0/15 (0.00%) 
Skin lesion  1  1/16 (6.25%)  1/15 (6.67%) 
Swelling face  1  0/16 (0.00%)  1/15 (6.67%) 
Surgical and medical procedures     
Knee arthroplasty  1  0/16 (0.00%)  1/15 (6.67%) 
Vascular disorders     
Flushing  1  1/16 (6.25%)  2/15 (13.33%) 
Haematoma  1  0/16 (0.00%)  1/15 (6.67%) 
Hot flush  1  1/16 (6.25%)  0/15 (0.00%) 
Hypertension  1  1/16 (6.25%)  1/15 (6.67%) 
Hypotension  1  2/16 (12.50%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01441973     History of Changes
Other Study ID Numbers: CA204-011
First Submitted: September 27, 2011
First Posted: September 28, 2011
Results First Submitted: December 22, 2015
Results First Posted: January 29, 2016
Last Update Posted: January 23, 2018