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Trial record 4 of 62 for:    "Al Amyloidosis" | "Immunosuppressive Agents"

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib (VelRand)

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ClinicalTrials.gov Identifier: NCT02489500
Recruitment Status : Terminated (Enrollment held for toxicity evaluation; then closed due to competing trial)
First Posted : July 3, 2015
Results First Posted : August 6, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition AL Amyloidosis
Interventions Drug: Bortezomib
Drug: Melphalan
Drug: Neupogen
Procedure: Stem Cell Collection
Procedure: Stem cell infusion
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Period Title: Overall Study
Started 2 1
Completed 1 0
Not Completed 1 1
Reason Not Completed
Death             1             1
Arm/Group Title Melphalan Melphalan + Bortezomib Total
Hide Arm/Group Description

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
1
 100.0%
2
  66.7%
>=65 years
1
  50.0%
0
   0.0%
1
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
1
 100.0%
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
1
 100.0%
3
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
 100.0%
1
  33.3%
White
1
  50.0%
0
   0.0%
1
  33.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  50.0%
0
   0.0%
1
  33.3%
1.Primary Outcome
Title Number of Participants With Hematologic Response
Hide Description Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description:

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
2.Secondary Outcome
Title Toxicities
Hide Description Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description:

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 2 1
Mean (Full Range)
Unit of Measure: events per participant
8.5
(4 to 13)
15
(15 to 15)
3.Secondary Outcome
Title Overall Survival
Hide Description duration of overall survival measured in days
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description:

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: days
43 29
4.Secondary Outcome
Title Number of Participants With Organ Response
Hide Description analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination, organ response data was not collected.
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description:

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description Adverse event data were collected from the time of study entry through the date of program discharge, once blood cell counts returned to normal.
 
Arm/Group Title Melphalan Melphalan + Bortezomib
Hide Arm/Group Description

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion

Bortezomib: Conditioning Regimen:

Drug: Bortezomib: 1.0 mg/m2/dose D –6, D –3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1

Melphalan: Conditioning Regimen:

Drug: Melphalan: 70-100 mg/m2/dose D –2, D –1 Stem Cell Transplant: D 0

Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days

Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells

Stem cell infusion: infusion of previously collected autologous stem cells

All-Cause Mortality
Melphalan Melphalan + Bortezomib
Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)      1/1 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Melphalan Melphalan + Bortezomib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)    
Blood and lymphatic system disorders     
neutropenia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
leukopenia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
thrombocytopenia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
pancytopenia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
Febrile Neutropenia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
General disorders     
fatigue  1  1/2 (50.00%)  1 1/1 (100.00%)  1
weakness  1  1/2 (50.00%)  1 1/1 (100.00%)  1
edema  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Infections and infestations     
sepsis  1  0/2 (0.00%)  0 1/1 (100.00%)  1
parainfluenza 4  1  0/2 (0.00%)  0 1/1 (100.00%)  1
bacteroids bacteremia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Nervous system disorders     
somnolence  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Renal and urinary disorders     
anuria  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
hypoxia  1  1/2 (50.00%)  1 1/1 (100.00%)  2
oliguria  1  1/2 (50.00%)  1 0/1 (0.00%)  0
pleural effusion  1  1/2 (50.00%)  1 0/1 (0.00%)  0
shortness of breath  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Vascular disorders     
hypotension  1  1/2 (50.00%)  1 1/1 (100.00%)  1
thromboembolic event  1  0/2 (0.00%)  0 1/1 (100.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Melphalan Melphalan + Bortezomib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)    
Cardiac disorders     
tachycardia  1  2/2 (100.00%)  2 0/1 (0.00%)  0
sinus tachycardia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Ear and labyrinth disorders     
photophobia  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Endocrine disorders     
syndrome of inappropriate antidiuretic hormone secretion (SIADH)  1  1/2 (50.00%)  1 0/1 (0.00%)  0
adrenal insufficience  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Eye disorders     
photosensitivity  1  1/2 (50.00%)  1 0/1 (0.00%)  0
ptosis  1  0/2 (0.00%)  0 1/1 (100.00%)  1
right pupil fixed  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Gastrointestinal disorders     
nausea  1  2/2 (100.00%)  3 1/1 (100.00%)  1
constipation  1  2/2 (100.00%)  2 1/1 (100.00%)  1
vomiting  1  2/2 (100.00%)  3 0/1 (0.00%)  0
altered taste  1  1/2 (50.00%)  1 0/1 (0.00%)  0
xerostomia  1  1/2 (50.00%)  1 0/1 (0.00%)  0
abdominal distention  1  1/2 (50.00%)  1 1/1 (100.00%)  1
pain, right upper quadrant  1  1/2 (50.00%)  1 0/1 (0.00%)  0
diarrhea  1  2/2 (100.00%)  5 1/1 (100.00%)  2
enterocolitis  1  0/2 (0.00%)  0 1/1 (100.00%)  1
dysguesia  1  1/2 (50.00%)  1 0/1 (0.00%)  0
throat discomfort  1  1/2 (50.00%)  1 0/1 (0.00%)  0
General disorders     
fatigue  1  1/2 (50.00%)  1 1/1 (100.00%)  1
gait disturbance  1  1/2 (50.00%)  1 1/1 (100.00%)  1
bleeding  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Hepatobiliary disorders     
hepatic pain, right upper quadrant  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Infections and infestations     
clostridium difficile  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Investigations     
alkaline phosphatase  1  2/2 (100.00%)  2 1/1 (100.00%)  1
Alanine Aminotransferase increase  1  2/2 (100.00%)  2 1/1 (100.00%)  1
aspartate aminotransferase increase  1  2/2 (100.00%)  2 1/1 (100.00%)  1
hyperbilirubinemia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Metabolism and nutrition disorders     
hyponatremia  1  1/2 (50.00%)  1 1/1 (100.00%)  1
hypernatremia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
hyperglycemia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
hyperphosphatemia  1  2/2 (100.00%)  2 0/1 (0.00%)  0
hypoalbuminemia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
increased creatinine  1  0/2 (0.00%)  0 1/1 (100.00%)  1
alkalosis  1  1/2 (50.00%)  1 0/1 (0.00%)  0
hypermagnesemia  1  1/2 (50.00%)  1 1/1 (100.00%)  1
Musculoskeletal and connective tissue disorders     
pain - bone  1  2/2 (100.00%)  2 1/1 (100.00%)  1
pain- apheresis line tenderness  1  2/2 (100.00%)  2 1/1 (100.00%)  1
pain: abdominal  1  0/2 (0.00%)  0 1/1 (100.00%)  1
presyncope  1  1/2 (50.00%)  2 0/1 (0.00%)  0
Nervous system disorders     
dizziness  1  2/2 (100.00%)  2 0/1 (0.00%)  0
weakness - bilateral tricep  1  0/2 (0.00%)  0 1/1 (100.00%)  1
neuropathy (unrelated to treatment)  1  1/2 (50.00%)  1 0/1 (0.00%)  0
syncope  1  1/2 (50.00%)  1 0/1 (0.00%)  0
somnolence  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Psychiatric disorders     
anxiety  1  2/2 (100.00%)  2 1/1 (100.00%)  1
hyperactive  1  1/2 (50.00%)  1 0/1 (0.00%)  0
insomnia  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Renal and urinary disorders     
urinary retention  1  1/2 (50.00%)  1 1/1 (100.00%)  1
creatinine increased  1  0/2 (0.00%)  0 1/1 (100.00%)  1
oliguria  1  1/2 (50.00%)  1 0/1 (0.00%)  0
acute kidney injury  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
hiccups  1  1/2 (50.00%)  1 0/1 (0.00%)  0
dyspnea  1  1/2 (50.00%)  1 1/1 (100.00%)  1
cough  1  0/2 (0.00%)  0 1/1 (100.00%)  1
pleural effusion  1  0/2 (0.00%)  0 1/1 (100.00%)  1
Skin and subcutaneous tissue disorders     
alopecia  1  2/2 (100.00%)  2 1/1 (100.00%)  1
bruising  1  2/2 (100.00%)  2 0/1 (0.00%)  0
purpura  1  1/2 (50.00%)  1 0/1 (0.00%)  0
pruritis  1  1/2 (50.00%)  1 0/1 (0.00%)  0
Vascular disorders     
edema  1  1/2 (50.00%)  1 1/1 (100.00%)  1
hypotension  1  1/2 (50.00%)  1 1/1 (100.00%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Early termination after enrollment held for toxicity evaluation; then closed due to competing trial.
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: Vaishali Sanchorawala, MD
Organization: Boston Medical Center
Phone: 6176388261
EMail: sfenness@bu.edu
Layout table for additonal information
Responsible Party: Vaishali Sanchorawala, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02489500     History of Changes
Other Study ID Numbers: H-33808
VelRand ( Other Identifier: Boston Medical Center )
First Submitted: March 9, 2015
First Posted: July 3, 2015
Results First Submitted: May 3, 2018
Results First Posted: August 6, 2018
Last Update Posted: September 10, 2018