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Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma (CarBiRD)

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ClinicalTrials.gov Identifier: NCT01559935
Recruitment Status : Active, not recruiting
First Posted : March 21, 2012
Results First Posted : March 22, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: carfilzomib
Drug: Dexamethasone
Drug: Clarithromycin
Drug: Lenalidomide
Enrollment 74
Recruitment Details  
Pre-assignment Details Two subjects were ineligible and therefore never started treatment.
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Period Title: Car Phase
Started 72
Completed 58
Not Completed 14
Reason Not Completed
Toxicity             4
Death             1
Lack of Efficacy             2
Lost to Follow-up             1
Physician Decision             1
Withdrawal by Subject             2
Per protocol             1
Insurance             1
non-compliance             1
Period Title: BiRD Phase
Started 58
Completed 54
Not Completed 4
Reason Not Completed
Toxicity             1
Lack of Efficacy             1
Withdrawal by Subject             2
Period Title: Maintenance Phase
Started 54
Completed 0
Not Completed 54
Reason Not Completed
Remains on study             28
Toxicity             1
Lack of Efficacy             18
Withdrawal by Subject             5
Non-compliance             2
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Age, Customized   [1] 
Mean (Full Range)
Unit of measure:  Years
Car Phase Number Analyzed 72 participants
60.4
(42 to 85)
BiRD Phase Number Analyzed 58 participants
59.6
(42 to 85)
Maintenance Phase Number Analyzed 54 participants
59.2
(42 to 79)
[1]
Measure Analysis Population Description: 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Car Phase Number Analyzed 72 participants
Female
29
  40.3%
Male
43
  59.7%
BiRD Phase Number Analyzed 58 participants
Female
26
  44.8%
Male
32
  55.2%
Maintenance Phase Number Analyzed 54 participants
Female
23
  42.6%
Male
31
  57.4%
[1]
Measure Analysis Population Description: 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Car Phase Number Analyzed 72 participants
Hispanic or Latino
3
   4.2%
Not Hispanic or Latino
61
  84.7%
Unknown or Not Reported
8
  11.1%
BiRD Phase Number Analyzed 58 participants
Hispanic or Latino
3
   5.2%
Not Hispanic or Latino
48
  82.8%
Unknown or Not Reported
7
  12.1%
Maintenance Phase Number Analyzed 54 participants
Hispanic or Latino
2
   3.7%
Not Hispanic or Latino
45
  83.3%
Unknown or Not Reported
7
  13.0%
[1]
Measure Analysis Population Description: 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Car Phase Number Analyzed 72 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   6.9%
White
29
  40.3%
More than one race
6
   8.3%
Unknown or Not Reported
32
  44.4%
BiRD Phase Number Analyzed 58 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   6.9%
White
22
  37.9%
More than one race
5
   8.6%
Unknown or Not Reported
27
  46.6%
Maintenance Phase Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   5.6%
White
20
  37.0%
More than one race
5
   9.3%
Unknown or Not Reported
26
  48.1%
[1]
Measure Analysis Population Description: 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
1.Primary Outcome
Title Response to Car-BiRD Treatment.
Hide Description

The best response for all patients who had at least one dose of drug was measured.

Response categories:

Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).

The response is evaluated based on the IMWG criteria.

Time Frame From baseline to best response, up to 116 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description:

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
sCR/CR
28
  38.9%
VGPR
31
  43.1%
PR
11
  15.3%
SD
1
   1.4%
PD
0
   0.0%
Not Evaluable
1
   1.4%
2.Secondary Outcome
Title Event Free Survival
Hide Description an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.
Time Frame From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.
Hide Outcome Measure Data
Hide Analysis Population Description
44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description:

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Participants Analyzed 44
Median (Full Range)
Unit of Measure: Days
401.5
(18 to 1222)
3.Secondary Outcome
Title MRD Negativity Following CarBiRD Regimen
Hide Description

Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.

MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.

MRD positivity is defined as the presence of residual plasma cells (<5%) on bone marrow biopsy.

The IMWG criteria were used to determine CR and sCR.

Time Frame From start of study up to Revlimid Maintenance Cycle 4.
Hide Outcome Measure Data
Hide Analysis Population Description
28 participants achieved CR or sCR.
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description:

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
MRD positive
10
  35.7%
MRD negative
17
  60.7%
Not Evaluable
1
   3.6%
4.Secondary Outcome
Title Progression Free Survival
Hide Description Progression was defined using the IMWG criteria.
Time Frame From start of study drug until first incidence of progression, up to 1222 days.
Hide Outcome Measure Data
Hide Analysis Population Description
21 participants had an incidence of progression.
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description:

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: months
18.3
(2.3 to 40.7)
5.Secondary Outcome
Title Stem Cells Collection
Hide Description At the end of the Car Phase, all participants underwent stem cell collection.
Time Frame At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.
Hide Outcome Measure Data
Hide Analysis Population Description
58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description:

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: Number of stem cells collected per Kg
12854635  (5388946.9)
Time Frame [Not Specified]
Adverse Event Reporting Description

Collection of adverse events is ongoing as 28 participants are still on trial.

For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased.

Grading was done using the CTCAE 4.0.

 
Arm/Group Title Car-BiRD Therapy
Hide Arm/Group Description

Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]

Car Phase:

carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.

BiRD Phase:

Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.

Maintenance Phase:

Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.

All-Cause Mortality
Car-BiRD Therapy
Affected / at Risk (%)
Total   1/72 (1.39%)    
Show Serious Adverse Events Hide Serious Adverse Events
Car-BiRD Therapy
Affected / at Risk (%) # Events
Total   26/72 (36.11%)    
Cardiac disorders   
atrial fibrilation  [1]  1/72 (1.39%)  1
massive heart attack  [1]  1/72 (1.39%)  1
acute coronary syndrome  [2]  1/58 (1.72%)  1
cardiac chest pain  [3]  1/54 (1.85%)  1
Gastrointestinal disorders   
diarrhea  [3]  1/54 (1.85%)  2
Infections and infestations   
abnominal infection  [1]  1/72 (1.39%)  2
lung infection  [1]  3/72 (4.17%)  4
URI  [1]  2/72 (2.78%)  2
UTI  [1]  2/72 (2.78%)  2
lung infection  [2]  3/58 (5.17%)  3
lung infection  [3]  4/54 (7.41%)  4
acute kidney infection  [3]  1/54 (1.85%)  1
enterocolitis infection  [3]  1/54 (1.85%)  1
Injury, poisoning and procedural complications   
fall  [1]  1/72 (1.39%)  1
Metabolism and nutrition disorders   
increased creatinine  [1]  1/72 (1.39%)  1
dehydration  [1]  1/72 (1.39%)  1
creatinine increase  [3]  1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders   
femur fracture  [1]  1/72 (1.39%)  1
spinal fracture  [1]  1/72 (1.39%)  1
back pain  [1]  1/72 (1.39%)  1
non-cardiac chest pain  [2]  1/58 (1.72%)  1
abdominal pain (small intestinal obstruction)  [2]  1/58 (1.72%)  1
non-cardiac chest pain  [3]  3/54 (5.56%)  3
spinal cord compression  [3]  1/54 (1.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
thyroid cancer  [1]  1/72 (1.39%)  1
secondary malignancy  [3]  1/54 (1.85%)  1
Nervous system disorders   
syncope  [1]  1/72 (1.39%)  1
confusion  [1]  1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea  [1]  2/72 (2.78%)  2
pulmonary embolism  [1]  1/72 (1.39%)  1
Surgical and medical procedures   
surgical procedure  [1]  1/72 (1.39%)  1
Vascular disorders   
fever  [1]  2/72 (2.78%)  3
thromboembolic event  [3]  1/54 (1.85%)  1
Indicates events were collected by systematic assessment
[1]
car phase
[2]
BiRD phase
[3]
Maintenance phase
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Car-BiRD Therapy
Affected / at Risk (%) # Events
Total   72/72 (100.00%)    
Blood and lymphatic system disorders   
anemia  [1]  52/72 (72.22%) 
thrombocytopenia  [1]  64/72 (88.89%) 
neutropenia  [1]  13/72 (18.06%) 
leukopenia  [1]  25/72 (34.72%) 
lymphopenia  [1]  69/72 (95.83%) 
neutropenia  [2]  6/58 (10.34%) 
leukopenia  [2]  5/58 (8.62%) 
lymphopenia  [2]  5/58 (8.62%) 
thrombocytopenia  [3]  3/54 (5.56%) 
neutropenia  [3]  18/54 (33.33%) 
leukopenia  [3]  11/54 (20.37%) 
Cardiac disorders   
high BNP  [1]  10/72 (13.89%) 
bradycardia  [3]  5/54 (9.26%) 
Eye disorders   
blurry vision  [3]  5/54 (9.26%) 
Gastrointestinal disorders   
dyspepsia  [1]  13/72 (18.06%) 
constipation  [1]  18/72 (25.00%) 
nausea  [1]  17/72 (23.61%) 
anorexia  [1]  6/72 (8.33%) 
diarhhea  [1]  25/72 (34.72%) 
vomiting  [1]  8/72 (11.11%) 
flatulance  [1]  7/72 (9.72%) 
dyspepsia  [2]  4/58 (6.90%) 
constipation  [2]  15/58 (25.86%) 
nausea  [2]  7/58 (12.07%) 
anorexia  [2]  4/58 (6.90%) 
diarhhea  [2]  4/58 (6.90%) 
vomiting  [2]  3/58 (5.17%) 
dry mouth  [2]  4/58 (6.90%) 
flatulance  [2]  3/58 (5.17%) 
dyspepsia  [3]  13/54 (24.07%) 
constipation  [3]  5/54 (9.26%) 
nausea  [3]  4/54 (7.41%) 
diarhhea  [3]  20/54 (37.04%) 
vomiting  [3]  7/54 (12.96%) 
dry mouth  [3]  3/54 (5.56%) 
flatulance  [3]  3/54 (5.56%) 
General disorders   
insomnia  [1]  27/72 (37.50%) 
fatigue  [1]  22/72 (30.56%) 
chills  [1]  4/72 (5.56%) 
insomnia  [2]  5/58 (8.62%) 
malaise  [2]  3/58 (5.17%) 
fatigue  [2]  9/58 (15.52%) 
fatigue  [3]  5/54 (9.26%) 
gait disturbance  [3]  4/54 (7.41%) 
hair loss  [3]  4/54 (7.41%) 
Infections and infestations   
URI  [1]  12/72 (16.67%) 
UTI  [1]  5/72 (6.94%) 
Skin Infection  [1]  4/72 (5.56%) 
URI  [3]  22/54 (40.74%) 
skin Infection  [3]  4/54 (7.41%) 
ear infection  [3]  3/54 (5.56%) 
Injury, poisoning and procedural complications   
fall  [3]  4/54 (7.41%) 
Metabolism and nutrition disorders   
hypocalcemia  [1]  56/72 (77.78%) 
hyponatremia  [1]  42/72 (58.33%) 
hypoglycemia  [1]  21/72 (29.17%) 
hyperglycemia  [1]  63/72 (87.50%) 
hypophosphatemia  [1]  35/72 (48.61%) 
hyperkalemia  [1]  20/72 (27.78%) 
hypokalemia  [1]  4/72 (5.56%) 
hypomagnesemia  [1]  14/72 (19.44%) 
hypermagnesemia  [1]  10/72 (13.89%) 
hypoalbuminemia  [1]  39/72 (54.17%) 
hyperbilirubinemia  [1]  23/72 (31.94%) 
hyperuricemia  [1]  5/72 (6.94%) 
hyperhidrosis  [1]  8/72 (11.11%) 
elevated ALT  [1]  26/72 (36.11%) 
elevated AST  [1]  30/72 (41.67%) 
elevated alkaline phosphatase  [1]  34/72 (47.22%) 
increased creatinine  [1]  35/72 (48.61%) 
hypocalcemia  [2]  6/58 (10.34%) 
hypoglycemia  [2]  14/58 (24.14%) 
hypokalemia  [2]  4/58 (6.90%) 
hypomagnesemia  [2]  7/58 (12.07%) 
elevated ALT  [2]  3/58 (5.17%) 
ALK increase  [2]  6/58 (10.34%) 
increased creatinine  [2]  4/58 (6.90%) 
hypocalcemia  [3]  7/54 (12.96%) 
hypercalcemia  [3]  3/54 (5.56%) 
hypoglycemia  [3]  7/54 (12.96%) 
hypophosphatemia  [3]  5/54 (9.26%) 
hypokalemia  [3]  4/54 (7.41%) 
hypomagnesemia  [3]  13/54 (24.07%) 
hypoalbuminemia  [3]  8/54 (14.81%) 
hyperbilirubinemia  [3]  5/54 (9.26%) 
hyponatremia  [3]  3/54 (5.56%) 
hypernatremia  [3]  5/54 (9.26%) 
elevated ALT  [3]  5/54 (9.26%) 
elevated AST  [3]  4/54 (7.41%) 
increased creatinine  [3]  7/54 (12.96%) 
Musculoskeletal and connective tissue disorders   
muscle spasms/cramps  [1]  13/72 (18.06%) 
muscle weakness  [1]  6/72 (8.33%) 
pain in legs  [1]  8/72 (11.11%) 
hip pain  [1]  7/72 (9.72%) 
back pain  [1]  17/72 (23.61%) 
knee pain  [1]  4/72 (5.56%) 
lower extremity pain  [1]  4/72 (5.56%) 
muscle spasms/cramps  [2]  6/58 (10.34%) 
hip pain  [2]  3/58 (5.17%) 
bone pain  [2]  3/58 (5.17%) 
muscle spasms/cramps  [3]  5/54 (9.26%) 
shoulder pain  [3]  5/54 (9.26%) 
rib pain  [3]  6/54 (11.11%) 
chest pain (muscular)  [3]  4/54 (7.41%) 
pain in legs  [3]  5/54 (9.26%) 
hip pain  [3]  10/54 (18.52%) 
back pain  [3]  8/54 (14.81%) 
arthralgias  [3]  11/54 (20.37%) 
neck pain  [3]  3/54 (5.56%) 
pain in foot  [3]  3/54 (5.56%) 
lower extremity pain  [3]  6/54 (11.11%) 
upper extremity pain  [3]  6/54 (11.11%) 
knee pain  [3]  3/54 (5.56%) 
Nervous system disorders   
peripheral neuropathy  [1]  12/72 (16.67%) 
tremor  [1]  10/72 (13.89%) 
anxiety/stress  [1]  13/72 (18.06%) 
dizziness / lightheaded  [1]  9/72 (12.50%) 
paresthesias  [1]  4/72 (5.56%) 
forgetful  [1]  4/72 (5.56%) 
dysgeusia  [1]  4/72 (5.56%) 
headache  [1]  12/72 (16.67%) 
irritability  [1]  5/72 (6.94%) 
agitation  [1]  4/72 (5.56%) 
concentration impairment  [1]  7/72 (9.72%) 
peripheral neuropathy  [2]  3/58 (5.17%) 
tremor  [2]  11/58 (18.97%) 
dizziness / lightheaded  [2]  5/58 (8.62%) 
parethesias  [2]  4/58 (6.90%) 
dysgeusia  [2]  17/58 (29.31%) 
irritability  [2]  7/58 (12.07%) 
peripheral neuropathy  [3]  7/54 (12.96%) 
dizziness / lightheaded  [3]  5/54 (9.26%) 
headache  [3]  3/54 (5.56%) 
Psychiatric disorders   
depression  [1]  6/72 (8.33%) 
anxiety/stress  [3]  3/54 (5.56%) 
depression  [3]  5/54 (9.26%) 
Renal and urinary disorders   
low eGFR  [1]  37/72 (51.39%) 
genitourinary frequency  [1]  4/72 (5.56%) 
low eGFR  [2]  4/58 (6.90%) 
genitourinary frequency  [3]  3/54 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  [1]  11/72 (15.28%) 
cough  [1]  12/72 (16.67%) 
sinus congestion  [1]  10/72 (13.89%) 
sore throat  [1]  4/72 (5.56%) 
dyspnea  [2]  3/58 (5.17%) 
lung infection  [2]  3/58 (5.17%) 
cough  [2]  3/58 (5.17%) 
sinus congestion  [2]  3/58 (5.17%) 
lung infection  [3]  3/54 (5.56%) 
cough  [3]  13/54 (24.07%) 
sore throat  [3]  3/54 (5.56%) 
sinus congestion  [3]  9/54 (16.67%) 
allergic rhinitis  [3]  7/54 (12.96%) 
Skin and subcutaneous tissue disorders   
rash  [1]  7/72 (9.72%) 
rash  [2]  13/58 (22.41%) 
pruritus  [2]  3/58 (5.17%) 
rash  [3]  10/54 (18.52%) 
skin darknening  [3]  5/54 (9.26%) 
pruritus  [3]  4/54 (7.41%) 
dry skin  [3]  7/54 (12.96%) 
Vascular disorders   
edema  [1]  14/72 (19.44%) 
hypertension  [1]  4/72 (5.56%) 
fever  [1]  14/72 (19.44%) 
edema  [2]  10/58 (17.24%) 
cushingoid appearance  [2]  3/58 (5.17%) 
edema  [3]  14/54 (25.93%) 
hypertension  [3]  5/54 (9.26%) 
Indicates events were collected by systematic assessment
[1]
Car phase
[2]
BiRD phase
[3]
Maintenance phase
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Hess
Organization: Weill Cornell Medicine
Phone: 6469629440
EMail: jmh2004@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01559935     History of Changes
Other Study ID Numbers: 1108011903
First Submitted: February 16, 2012
First Posted: March 21, 2012
Results First Submitted: February 1, 2017
Results First Posted: March 22, 2017
Last Update Posted: June 11, 2019