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Trial record 21 of 372 for:    LENALIDOMIDE AND Dexamethasone

Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM)

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ClinicalTrials.gov Identifier: NCT01651039
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ajai Chari, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Panobinostat
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 32
Recruitment Details Recruitment began in July 2012 with enrollment from Sept 2012 to August 2015. 41 subjects signed consent (7 screened failed, 32 received study treatment, 5 non-evaluables). 27 out of the 32 subjects are evaluable.
Pre-assignment Details  
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description

All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.

Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.

Period Title: Overall Study
Started 32
Completed 2
Not Completed 30
Reason Not Completed
Non-evaluables             5
Physician Decision             2
Withdrawal by Subject             1
Progressive Disease             22
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description

All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol.

Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
27 out of the 32 subjects are evaluable because the 5 patients either did not complete cycle 1, or enrolled but never dosed.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
64
(51 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
11
  40.7%
Male
16
  59.3%
Age >65 years  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
14
  51.9%
The Eastern Cooperative Oncology Group (ECOG) Performance   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
0
16
  59.3%
1
11
  40.7%
2
0
   0.0%
[1]
Measure Description:

ECOG measures level of functioning in terms of daily living abilities:

0 - Fully active, able to carry on all pre-disease performance without restriction

  1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
ISS Staging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Stage 1
5
  18.5%
Stage 2
5
  18.5%
Stage 3
5
  18.5%
missing
12
  44.4%
[1]
Measure Description:

The International Staging System (ISS) for Multiple Myeloma

Stage 1 ß2-M < 3.5 mg/dL and albumin =3.5 g/dL

Stage 2 Neither stage 1 nor stage 3

Stage 3 ß2-M ≥ 5.5 mg/L

Immunoglobulin subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
IgG
14
  51.9%
IgA
8
  29.6%
IgM
1
   3.7%
None
4
  14.8%
FISH  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Normal
2
   7.4%
Any abnormality
22
  81.5%
Any high risk abnormality
17
  63.0%
del(17p)
5
  18.5%
chr1 amplification
12
  44.4%
t(4;14)
4
  14.8%
del(13q)
5
  18.5%
t(11;14)
5
  18.5%
Median time since diagnosis  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
4
(1.6 to 12.4)
Prior regimens   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
3
(1 to 10)
[1]
Measure Description: Number of years participant was on any prior regimens
Prior therapy   [1] 
Median (Full Range)
Unit of measure:  Regimens
Number Analyzed 27 participants
3
(1 to 10)
[1]
Measure Description: The number of prior treatments the participants had received prior to baseline visit
Prior Therapy, Exposed   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Dexamethasone
27
 100.0%
Thalidomide
6
  22.2%
Lenalidomide
27
 100.0%
Pomalidomide
10
  37.0%
Bortezomib
27
 100.0%
Carfilzomib
8
  29.6%
Autologous stem cell transplant
20
  74.1%
[1]
Measure Description: The number of participants that received any of the following chemo drugs
Prior therapy, Refractory   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Dexamethasone
19
  70.4%
Thalidomide
2
   7.4%
Lenalidomide
22
  81.5%
Pomalidomide
19
  70.4%
Bortezomib
14
  51.9%
Carfilzomib
7
  25.9%
[1]
Measure Description: The number of participants that received any of the following chemo drugs and relapsed from it.
Median cumulative duration of prior lenalidomide (len) months  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 27 participants
13
(4 to 20)
Prior len regimens  
Median (Full Range)
Unit of measure:  Regimens
Number Analyzed 27 participants
1
(1 to 2)
Doses of lenalidomide at time of PD on len  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
25
7
  25.9%
15
5
  18.5%
10
7
  25.9%
5
1
   3.7%
unknown
2
   7.4%
Not Len Refractory Patients
5
  18.5%
Progressed while on last len regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
22
  81.5%
Len in most recent prior regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
13
  48.1%
Pom in most recent prior regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
3
  11.1%
Dex in most recent prior regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
21
  77.8%
Dex in last len-containing regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
23
  85.2%
Best response at last treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Complete response
2
   7.4%
Very Good Partial Response
4
  14.8%
Partial Response
5
  18.5%
Minimal Response
9
  33.3%
Stable Disease
6
  22.2%
Progressive disease
1
   3.7%
1.Primary Outcome
Title The Best Overall Response Rate (ORR)
Hide Description The primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
11
  40.7%
2.Primary Outcome
Title Overall Response Rate for Len Refractory Patients
Hide Description The primary endpoint will be the best overall response rate (ORR)
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only Len Refractory Patients
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
8
  36.4%
3.Secondary Outcome
Title Response Rates
Hide Description

Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).

CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 – 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.

SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline

Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
2
   7.4%
Very Good Partial Response (VGPR)
4
  14.8%
Partial Response (PR)
5
  18.5%
Minimal Response (MR)
9
  33.3%
Stable Disease (SD)
6
  22.2%
Progressive Disease (PD)
1
   3.7%
4.Secondary Outcome
Title Response Rates for Len Refractory Patients
Hide Description

Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).

CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 – 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.

SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline

Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   4.5%
Very Good Partial Response
4
  18.2%
Partial Response
3
  13.6%
Minimal Response
7
  31.8%
Stable Disease
6
  27.3%
Progressive Disease
1
   4.5%
5.Secondary Outcome
Title Clinical Benefit Rate
Hide Description The number of response rates in participants that have achieved MR, PR, VGPR, CR
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
20
  74.1%
6.Secondary Outcome
Title Clinical Benefit Rate for Len Refractory Patients
Hide Description The number of response rates in Lens Refractory participants that have achieved MR, PR, VGPR, CR
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only Len Refractory Patients
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
15
  68.2%
7.Secondary Outcome
Title Disease Control Rate
Hide Description The number of response rates participants with SD, MR, PR, VGPR, or CR
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
26
  96.3%
8.Secondary Outcome
Title Disease Control Rate for Lens Refractory Rate
Hide Description The number of response rates in Len refractory participants with SD, MR, PR, VGPR, or CR
Time Frame up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Panobinostat, Lenalidomide and Dexamethasone
Hide Arm/Group Description:
All patients received oral panobinostat, lenalidomide and dexamethasone as per protocol
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
21
  95.5%
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events collected for all subjects who signed consent
 
Arm/Group Title All Subjects
Hide Arm/Group Description Adverse events collected for all subjects who signed consent.
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   1/41 (2.44%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   14/41 (34.15%)    
Blood and lymphatic system disorders   
Neutropenia  1/41 (2.44%)  1
Pulmonary Embolism  1/41 (2.44%)  1
Thrombocytopenia  1/41 (2.44%)  1
Cardiac disorders   
Cardiac Catherization  1/41 (2.44%)  1
Chest Pain  1/41 (2.44%)  1
Hypotension  1/41 (2.44%)  1
General disorders   
Failure to thrive  1/41 (2.44%)  1
Shortness of breath  1/41 (2.44%)  1
Infections and infestations   
Ehrlichiosis Babesiosis  1/41 (2.44%)  1
Sepsis  1/41 (2.44%)  1
Metabolism and nutrition disorders   
Hypercalcemia  2/41 (4.88%)  2
Musculoskeletal and connective tissue disorders   
Neck Pain  2/41 (4.88%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia  2/41 (4.88%)  3
Surgical and medical procedures   
Lap low Anterior Surgery  1/41 (2.44%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%) # Events
Total   38/41 (92.68%)    
Blood and lymphatic system disorders   
Anemia  18/41 (43.90%)  56
bilateral submandibular lymph node pain  1/41 (2.44%)  1
Bruising  1/41 (2.44%)  1
Bruising (right abd)  1/41 (2.44%)  1
DVT left leg  1/41 (2.44%)  1
DVT right leg  1/41 (2.44%)  1
Edema  1/41 (2.44%)  1
Epistaxis  2/41 (4.88%)  3
Hematoma [1]  1/41 (2.44%)  1
Left lower extremities deep vein thrombosis  1/41 (2.44%)  1
leukocyte count decreased  7/41 (17.07%)  14
leukopenia  4/41 (9.76%)  8
Lymphopenia  7/41 (17.07%)  25
Neutropenia  26/41 (63.41%)  176
Cardiac disorders   
Atypical Chest Pain  1/41 (2.44%)  1
Bradycardia  1/41 (2.44%)  2
Conduction disorder [2]  1/41 (2.44%)  1
hypertension  3/41 (7.32%)  7
Hypotension  2/41 (4.88%)  4
Palpitations  1/41 (2.44%)  1
Endocrine disorders   
Adrenal insufficiency  1/41 (2.44%)  1
Eye disorders   
Blurry vision  1/41 (2.44%)  1
Cataracts in both eyes  1/41 (2.44%)  1
Dry eyes  1/41 (2.44%)  1
Optic nerve damage  1/41 (2.44%)  1
Gastrointestinal disorders   
Abdominal Pain  4/41 (9.76%)  4
Abdominal discomfort  1/41 (2.44%)  1
Acute GI upset  1/41 (2.44%)  1
Blood in stool  1/41 (2.44%)  1
Colitis  1/41 (2.44%)  1
Constipation  13/41 (31.71%)  17
decreased appetite  1/41 (2.44%)  1
Diarrhea  16/41 (39.02%)  29
Diarrhea intermittent  1/41 (2.44%)  1
Fistula [3]  1/41 (2.44%)  1
Flatulence  1/41 (2.44%)  1
Gastroesophageal Reflux Disease  3/41 (7.32%)  4
GI symptoms  1/41 (2.44%)  1
Hemorrhoid pain  1/41 (2.44%)  1
intermittent diarrhea  1/41 (2.44%)  1
loose stools  1/41 (2.44%)  1
General disorders   
Allergic rhinitis  1/41 (2.44%)  1
Altered smell  1/41 (2.44%)  1
Altered taste  2/41 (4.88%)  2
Anorexia  7/41 (17.07%)  8
anorexia intermittent  1/41 (2.44%)  1
Bleeding gums  1/41 (2.44%)  1
Bloating  2/41 (4.88%)  2
Burning would right foot  1/41 (2.44%)  1
Cheek flushing  1/41 (2.44%)  1
Cheek pain  1/41 (2.44%)  2
Chest discomfort  1/41 (2.44%)  1
Chest Pain  1/41 (2.44%)  1
Chest Pain Intermittent  1/41 (2.44%)  1
Chest tightness  1/41 (2.44%)  1
Chills  3/41 (7.32%)  3
Congestion  1/41 (2.44%)  1
Cough, dry  1/41 (2.44%)  1
Dry mouth  2/41 (4.88%)  2
Dyspnea on exertion  2/41 (4.88%)  2
Dyspepsia  2/41 (4.88%)  4
Dyspnea  1/41 (2.44%)  1
Facial swellinig  1/41 (2.44%)  1
Fall  2/41 (4.88%)  3
Fatigue  23/41 (56.10%)  44
Fatigue (post dex)  1/41 (2.44%)  3
Fever  7/41 (17.07%)  14
Flank/lats discomfort  1/41 (2.44%)  1
forehead bumps  1/41 (2.44%)  1
Gum irritation  1/41 (2.44%)  1
Headache  5/41 (12.20%)  7
Headache, intermittent  2/41 (4.88%)  2
Hiccups  1/41 (2.44%)  1
Hoarse voice  2/41 (4.88%)  2
Hoarseness  2/41 (4.88%)  2
hot flashes [4]  1/41 (2.44%)  1
hyperpigmentation of soles  1/41 (2.44%)  1
hypersalivation  1/41 (2.44%)  1
hypoguesia  1/41 (2.44%)  1
Hypoxia  1/41 (2.44%)  1
increased gas  1/41 (2.44%)  1
increased phosphorus  1/41 (2.44%)  3
increased thirst  1/41 (2.44%)  1
insomnia  10/41 (24.39%)  12
insomnia (post dex)  1/41 (2.44%)  1
intermittent dry cough  1/41 (2.44%)  1
intermittent headache  1/41 (2.44%)  1
intermittent heartburn  1/41 (2.44%)  1
Jitters (with dex)  1/41 (2.44%)  2
LE edema  2/41 (4.88%)  7
LE weakness  1/41 (2.44%)  1
Left ankle edema  1/41 (2.44%)  1
Leg cramps  4/41 (9.76%)  4
localized edema  1/41 (2.44%)  1
Lower extremity edema [5]  1/41 (2.44%)  1
Malaise  2/41 (4.88%)  2
Minor congestion dry cough  1/41 (2.44%)  1
Mood irritability  1/41 (2.44%)  1
Mood Swings/Confusion  1/41 (2.44%)  1
Mouth sore  2/41 (4.88%)  2
Nasal congestion  1/41 (2.44%)  1
Nausea  11/41 (26.83%)  16
Nausea intermittent  1/41 (2.44%)  1
Nausea/vomiting  1/41 (2.44%)  1
Neck numbness  1/41 (2.44%)  1
Neck pain  2/41 (4.88%)  2
Neuropathy  4/41 (9.76%)  4
Nightsweats  1/41 (2.44%)  1
Nose bleeding  1/41 (2.44%)  1
Pain at the base of skull  1/41 (2.44%)  1
Pain on upper extremities  1/41 (2.44%)  1
Pedal Edema  2/41 (4.88%)  2
Peripheral Neuropathy  1/41 (2.44%)  1
Peripheral Neuropathy Bilateral  1/41 (2.44%)  1
Poor appetite  1/41 (2.44%)  1
Hepatobiliary disorders   
bilirubin increase  3/41 (7.32%)  5
Creatinine increase  2/41 (4.88%)  2
Infections and infestations   
C. Difficile  1/41 (2.44%)  1
Dental abscess  1/41 (2.44%)  1
Fungal rash  1/41 (2.44%)  1
infection  1/41 (2.44%)  1
influenza  1/41 (2.44%)  1
Oral Thrush  1/41 (2.44%)  1
Paronchytis  1/41 (2.44%)  1
Pneumonia  3/41 (7.32%)  3
Pneumonia (SOB)  1/41 (2.44%)  2
Metabolism and nutrition disorders   
Alanine Aminotransferase  2/41 (4.88%)  2
Alk phos elevation  1/41 (2.44%)  1
ALT elevation  1/41 (2.44%)  2
ALT increased  1/41 (2.44%)  2
hyperbilirubinemia  2/41 (4.88%)  2
hypercalcemia  3/41 (7.32%)  6
hyperglycemia  2/41 (4.88%)  7
hyperkalemia  2/41 (4.88%)  3
Hypermagnesemia  1/41 (2.44%)  1
hyperphosphatemia  2/41 (4.88%)  2
hypoalbuminemia  1/41 (2.44%)  2
hypocalcemia  1/41 (2.44%)  4
hypokalemia  7/41 (17.07%)  9
Hypomagnesemia  1/41 (2.44%)  1
hypomagnesia  1/41 (2.44%)  1
hyponatremia  2/41 (4.88%)  3
Hypophosphatemia  5/41 (12.20%)  7
hypophosphorous  1/41 (2.44%)  1
increased blood sugar  1/41 (2.44%)  1
increased creatinine  1/41 (2.44%)  1
Low magnesium  2/41 (4.88%)  2
Mildly elevated phosphorus  1/41 (2.44%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1/41 (2.44%)  1
Bilateral knee pain  1/41 (2.44%)  1
Bilateral lower extremity cramps  2/41 (4.88%)  2
Bilateral leg pain  1/41 (2.44%)  1
Body aches  1/41 (2.44%)  1
Bone pain  2/41 (4.88%)  2
Bone pain - Right wrist  1/41 (2.44%)  1
C3-C4 compression fracture  1/41 (2.44%)  1
Cramping  1/41 (2.44%)  1
Cramps on both legs  1/41 (2.44%)  1
Hand cramps  2/41 (4.88%)  2
jaw pain  2/41 (4.88%)  3
L rib pain  2/41 (4.88%)  2
L Upper Leg Bone pain  1/41 (2.44%)  1
Left sternal pain (intermittent)  1/41 (2.44%)  1
Lower back pain  1/41 (2.44%)  3
Mid back bone pain  1/41 (2.44%)  1
Mid-back Pain  1/41 (2.44%)  1
Muscle cramps  2/41 (4.88%)  2
Muscle spasms  1/41 (2.44%)  1
Myalgia  3/41 (7.32%)  3
Nervous system disorders   
Balance issue  1/41 (2.44%)  1
Confusion  1/41 (2.44%)  1
Dizziness  7/41 (17.07%)  7
Dizziness intermittent  1/41 (2.44%)  1
Psychiatric disorders   
Depression  4/41 (9.76%)  4
Renal and urinary disorders   
Acute kidney injury  1/41 (2.44%)  1
acute renal insufficiency  1/41 (2.44%)  2
Dysuria  2/41 (4.88%)  2
Foam in urine  2/41 (4.88%)  2
Hematuria  2/41 (4.88%)  2
Respiratory, thoracic and mediastinal disorders   
Chest congestion  1/41 (2.44%)  1
Cough  10/41 (24.39%)  16
Cough/cold  1/41 (2.44%)  1
Skin and subcutaneous tissue disorders   
Cheiilitis  1/41 (2.44%)  1
intermittent itching  1/41 (2.44%)  1
Vascular disorders   
Bilateral lower extremity swelling  3/41 (7.32%)  3
[1]
right forearm
[2]
T wave inversion
[3]
colon/bladder
[4]
post dex
[5]
L>R
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: Dr. Ajai Chari
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-7873
EMail: ajai.chari@mountsinai.org
Layout table for additonal information
Responsible Party: Ajai Chari, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01651039     History of Changes
Other Study ID Numbers: GCO 12-0469
CLBH589DUS85T
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: January 17, 2018
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018