A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01163786
• Collaborator: Robert H. Lurie Cancer Center (Other)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 59.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common late noninfectious complication following allogeneic hematopoietic stem cell transplant. Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent obstructive airways disease and viral infections1. BO is characterized physiologically by progressive irreversible airflow obstruction and pathologically by luminal occlusion of the distal airways due to progressive scarring3. The pathogenesis is not completely understood but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with other data in the literature that proteasomal inhibition can prevent the development of fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of bortezomib in chronic pulmonary GVHD (BO).

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Drug: Bortezomib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
• Actual Study Start Date: Oct 7, 2010
• Actual Primary Completion Date: Sep 9, 2015
• Actual Study Completion Date: Sep 9, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bortezomib Patients will Receive 2 4week cycles of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.	Drug: Bortezomib; Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib wil be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.; Other Names: Velcade

Outcome Measures

Primary Outcome Measures

1. Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline [Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline]

   FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.

Secondary Outcome Measures

1. Exercise Tolerance- 6 Minute Walk [Up to 18 weeks from baseline]

   Patients will have an exercise tolerance assessment defined as a 6 minute walk completed at cycle 1 (week 1) and cycle 2 (week 5) of treatment and visit 9 (12 weeks) and visit 10 (18 weeks).

2. Short Form (SF)-36 Health Survey [up to 18 weeks]

   This is a quality of life questionnaire which yields scores for 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). This questionnaire will be completed by patients on Visit 1 (week 1), Visit 5 (week 5), Visit 8 (week 8), Visit 9 (12 weeks), and Visit 10 (18 weeks). Questionnaires were scored per the scoring rules for the RAND 36-Item Health Survey (version 1.0) A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.

• Male subject agrees to use an acceptable method for contraception for the duration of the study.

• Day >100 after allogeneic hematopoietic stem cell transplantation

• Underlying cancer in remission

• Decrease in FEV1 of ≥12% from the pre-transplant baseline (FEV1/FVC ratio <0.8)

• No evidence of acute infection

• ANC >1000

• Platelets >50,000

• Age 18-70

• ECOG performance Status 0-2.

Exclusion Criteria:

• Patient has a platelet count of less than 50,000 within 14 days before enrollment.

• Patient has an absolute neutrophil count of less 1000 within 14 days before enrollment.

• Patient has a calculated or measured creatinine clearance of < 20 ml/minute within 14 days before enrollment.

• Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.

• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

• Patient has hypersensitivity to bortezomib, boron or mannitol.

• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

• Patient has received other investigational drugs with 14 days before enrollment

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Inability of give consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Robert H. Lurie Cancer Center

Investigators

• Principal Investigator: Manu Jain, MD, MS, Northwestern University
• Principal Investigator: Jayesh Mehta, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• This is the scoring system used in Short Form -36 Health Survey outcome measure

Publications

None provided.

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT01163786
• Other Study ID Numbers: NU 09H7; NU 09H7; STU00022160
• First Posted: Jul 16, 2010
• Last Update Posted: Apr 10, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Northwestern University: Bortezomib GVHD Bronchiolitis Obliterans
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bortezomib

Study Results

Participant Flow

Recruitment Details	The study opened for accrual on July 20, 2010 with an accrual goal of up to 20 evaluable patients. The first patient being enrolled on the study on October 7th 2010. The study was closed permanently on August 31 2015 before the accrual goal was met with 17 patients being treated on study.
Pre-assignment Detail	Patients were diagnosed with pulmonary Chronic Graft Verses Host Disease (p-CGVHD) after having undergone allogeneic hematopoietic stem cell transplant (HSCT). Patients were required to be less than 100 days post HSCT, with an absolute decrease of 12% or more in forced expiratory volume in 1 second (FEV1) from pre-transplant baseline.

Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Period Title: Treatment With Bortezomib
STARTED	17
Completed 1st Cycle	17
Completed 2nd Cycle	14
COMPLETED	14
NOT COMPLETED	3
Period Title: Treatment With Bortezomib
STARTED	14
Completed Week 12 Follow up (Visit 9)	14
Completed Week 18 Follow up (Visit 10)	13
COMPLETED	13
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 88.2%
>=65 years	2 11.8%
Sex: Female, Male (Count of Participants)
Female	4 23.5%
Male	13 76.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 17.6%
Not Hispanic or Latino	14 82.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5.9%
White	15 88.2%
More than one race	0 0%
Unknown or Not Reported	1 5.9%
Region of Enrollment (participants) [Number]
United States	17 100%
Disease (Count of Participants)
Acute Leukemia	6 35.3%
Chronic Myelogenous Leukemia	3 17.6%
Lymophoma	4 23.5%
Myeloma	2 11.8%
Other	2 11.8%
Sex Matching of Transplantation (Count of Participants)
Female-female	1 5.9%
Female-male	3 17.6%
male-female	5 29.4%
male-male	8 47.1%
Transplant Type (Count of Participants)
Matched Sibling	12 70.6%
Matched unrelated	4 23.5%
Mini matched unrelated	1 5.9%
Plumonary Function Testing (PFT) at time of transplant (percentage) [Mean (Standard Deviation) ]
Forced Expiratory Volume in 1 Second (FEV1)	90 (17)
Forced Vital Capacity (FVC)	89 (18)
FEV/FVC	81 (5)
lumonary Function Testing at time of pulmonary Chronic Graft-verses-host disease (pGVHD) Diagnosis (percentage) [Mean (Standard Deviation) ]
Forced Expiratory Volume in 1 Second (FEV1)	47 (16)
Forced Vital Capacity (FVC)	60 (15)
FEV/FVC	61 (14)
Time from transplant to pGVHD diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.36 (1.88)

Outcome Measures

1. Primary Outcome

Title	Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline
Description	FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.
Time Frame	Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Measure Participants	17
Prior to diagnosis of p-CGVHD	-1.06
During Treatment with Bortezomib	-0.25

2. Secondary Outcome

Title	Exercise Tolerance- 6 Minute Walk
Description	Patients will have an exercise tolerance assessment defined as a 6 minute walk completed at cycle 1 (week 1) and cycle 2 (week 5) of treatment and visit 9 (12 weeks) and visit 10 (18 weeks).
Time Frame	Up to 18 weeks from baseline

Outcome Measure Data

Analysis Population Description

Data was collected but not analyzed due to the study closing before accrual was met. Below is data on how many patients started 6 minute walk and how many patients stopped before reaching 6 minutes at each time point is shown below.

Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Measure Participants	13
Cycle 1 (Visit 1): Started 6 Minute walk	13 76.5%
Cycle 1 (Visit 1): Stopped before 6 minutes	3 17.6%
Cycle 1(Visit 1):Declined walk	0 0%
Cycle 2 (Visit 5) : Started 6 Minute walk	3 17.6%
Cycle 2 (Visit 5) : Stopped before 6 minutes	0 0%
Cycle 2(Visit 5):Declined walk	0 0%
Follow up/Visit 9: Started 6 Minute walk	6 35.3%
Follow up/Visit 9 : Stopped before 6 minutes	1 5.9%
Follow up/Visit 9: Declined walk	1 5.9%
Follow up/Visit 10 : Started 6 Minute walk	5 29.4%
Follow up/Visit 10 : Stopped before 6 minutes	1 5.9%
Follow up/Visit 10: Declined walk	1 5.9%

3. Secondary Outcome

Title	Short Form (SF)-36 Health Survey
Description	This is a quality of life questionnaire which yields scores for 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). This questionnaire will be completed by patients on Visit 1 (week 1), Visit 5 (week 5), Visit 8 (week 8), Visit 9 (12 weeks), and Visit 10 (18 weeks). Questionnaires were scored per the scoring rules for the RAND 36-Item Health Survey (version 1.0) A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
Time Frame	up to 18 weeks

Outcome Measure Data

Analysis Population Description

Data was collected but not analyzed. Averages for each patient at each timepoint are shown below. N/a is shown for timepoints where data was not collected.

Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Measure Participants	17
Pt #01 Physical Functioning : Visit 1	30
Pt #01 Physical Functioning : Visit 5	55
Pt #01 Physical Functioning : Visit 8	NA
Pt #01 Physical Functioning : Visit 9	NA
Pt #01 Physical Functioning : Visit 10	NA
Pt #01 Role-physical : Visit 1	0
Pt #01 Role-physical : Visit 5	25
Pt #01 Role-physical : Visit 8	NA
Pt #01 Role-physical : Visit 9	NA
Pt #01 Role-physical : Visit 10	NA
Pt #01 Role-emotional : Visit 1	100
Pt #01 Role-emotional : Visit 5	66.67
Pt #01 Role-emotional : Visit 8	NA
Pt #01 Role-emotional : Visit 9	NA
Pt #01 Role-emotional : Visit 10	NA
Pt #01 Energy/fatigue : Visit 1	50
Pt #01 Energy/fatigue : Visit 5	35
Pt #01 Energy/fatigue : Visit 8	NA
Pt #01 Energy/fatigue : Visit 9	NA
Pt #01 Energy/fatigue : Visit 10	NA
Pt #01 Emotional Well-being : Visit 1	88
Pt #01 Emotional Well-being : Visit 5	84
Pt #01 Emotional Well-being : Visit 8	NA
Pt #01 Emotional Well-being : Visit 9	NA
Pt #01 Emotional Well-being : Visit 10	NA
Pt #01 Social Functioning : Visit 1	87.5
Pt #01 Social Functioning : Visit 5	75
Pt #01 Social Functioning : Visit 8	NA
Pt #01 Social Functioning : Visit 9	NA
Pt #01 Social Functioning : Visit 10	NA
Pt #01 Pain : Visit 1	100
Pt #01 Pain : Visit 5	55
Pt #01 Pain : Visit 8	NA
Pt #01 Pain : Visit 9	NA
Pt #01 Pain : Visit 10	NA
Pt #01 General Health : Visit 1	65
Pt #01 General Health : Visit 5	55
Pt #01 General Health : Visit 8	NA
Pt #01 General Health : Visit 9	NA
Pt #01 General Health : Visit 10	NA
Pt #2 Physical Functioning : Visit 1	30
Pt #2 Physical Functioning : Visit 5	NA
Pt #2 Physical Functioning : Visit 8	30
Pt #2 Physical Functioning : Visit 9	30
Pt #2 Physical Functioning : Visit 10	75
Pt #2 Role-physical : Visit 1	0
Pt #2 Role-physical : Visit 5	NA
Pt #2 Role-physical : Visit 8	0
Pt #2 Role-physical : Visit 9	0
Pt #2 Role-physical : Visit 10	100
Pt #2 Role-emotional : Visit 1	0
Pt #2 Role-emotional : Visit 5	NA
Pt #2 Role-emotional : Visit 8	100
Pt #2 Role-emotional : Visit 9	100
Pt #2 Role-emotional : Visit 10	100
Pt #2 Energy/fatigue : Visit 1	25
Pt #2 Energy/fatigue : Visit 5	NA
Pt #2 Energy/fatigue : Visit 8	40
Pt #2 Energy/fatigue : Visit 9	20
Pt #2 Energy/fatigue : Visit 10	55
Pt #2 Emotional Well-being : Visit 1	84
Pt #2 Emotional Well-being : Visit 5	NA
Pt #2 Emotional Well-being : Visit 8	88
Pt #2 Emotional Well-being : Visit 9	92
Pt #2 Emotional Well-being : Visit 10	76
Pt #2 Social Functioning : Visit 1	87.5
Pt #2 Social Functioning : Visit 5	NA
Pt #2 Social Functioning : Visit 8	87.5
Pt #2 Social Functioning : Visit 9	87.5
Pt #2 Social Functioning : Visit 10	87.5
Pt #2 Pain : Visit 1	32.5
Pt #2 Pain : Visit 5	NA
Pt #2 Pain : Visit 8	45
Pt #2 Pain : Visit 9	45
Pt #2 Pain : Visit 10	45
Pt #2 General Health : Visit 1	25
Pt #2 General Health : Visit 5	NA
Pt #2 General Health : Visit 8	35
Pt #2 General Health : Visit 9	31.25
Pt #2 General Health : Visit 10	30
Pt #3 Physical Functioning : Visit 1	16.67
Pt #3 Physical Functioning : Visit 5	NA
Pt #3 Physical Functioning : Visit 8	30
Pt #3 Physical Functioning : Visit 9	40
Pt #3 Physical Functioning : Visit 10	30
Pt #3: Role-physical : Visit 1	25
Pt #3: Role-physical : Visit 5	NA
Pt #3: Role-physical : Visit 8	0
Pt #3: Role-physical : Visit 9	0
Pt #3: Role-physical : Visit 10	0
Pt #3: Role-emotional : Visit 1	NA
Pt #3: Role-emotional : Visit 5	NA
Pt #3: Role-emotional : Visit 8	100
Pt #3: Role-emotional : Visit 9	100
Pt #3: Role-emotional : Visit 10	100
Pt #3: Energy/fatigue : Visit 1	20
Pt #3: Energy/fatigue : Visit 5	NA
Pt #3: Energy/fatigue : Visit 8	5
Pt #3: Energy/fatigue : Visit 9	5
Pt #3: Energy/fatigue : Visit 10	5
Pt #3: Emotional Well-being : Visit 1	88
Pt #3: Emotional Well-being : Visit 5	NA
Pt #3: Emotional Well-being : Visit 8	68
Pt #3: Emotional Well-being : Visit 9	68
Pt #3: Emotional Well-being : Visit 10	72
Pt #3 : Social Functioning : Visit 1	75
Pt #3 : Social Functioning : Visit 5	NA
Pt #3 : Social Functioning : Visit 8	62.5
Pt #3 : Social Functioning : Visit 9	87.5
Pt #3 : Social Functioning : Visit 10	75
Pt #3 Pain : Visit 1	90
Pt #3 Pain : Visit 5	NA
Pt #3 Pain : Visit 8	100
Pt #3 Pain : Visit 9	100
Pt #3 Pain : Visit 10	90
Pt #3 : General Health : Visit 1	10
Pt #3 : General Health : Visit 5	20
Pt #3 : General Health : Visit 8	31.25
Pt #3 : General Health : Visit 9	20
Pt #3 : General Health : Visit 10	20
Pt #4 : Physical Functioning : Visit 1	45
Pt #4 : Physical Functioning : Visit 5	60
Pt #4 : Physical Functioning : Visit 8	33.33
Pt #4 : Physical Functioning : Visit 9	50
Pt #4 : Physical Functioning : Visit 10	50
Pt #4 : Role-physcial : Visit 1	NA
Pt #4 : Role-physcial : Visit 5	25
Pt #4 : Role-physcial : Visit 8	100
Pt #4 : Role-physcial : Visit 9	NA
Pt #4 : Role-physcial : Visit 10	75
Pt #4 : Role-emotional : Visit 1	33.33
Pt #4 : Role-emotional : Visit 5	0
Pt #4 : Role-emotional : Visit 8	0
Pt #4 : Role-emotional : Visit 9	33.33
Pt #4 : Role-emotional : Visit 10	33.33
Pt #4 : Energy/fatigue : Visit 1	25
Pt #4 : Energy/fatigue : Visit 5	35
Pt #4 : Energy/fatigue : Visit 8	35
Pt #4 : Energy/fatigue : Visit 9	30
Pt #4 : Energy/fatigue : Visit 10	35
Pt #4 : Emotional Well-being : Visit 1	60
Pt #4 : Emotional Well-being : Visit 5	56
Pt #4 : Emotional Well-being : Visit 8	72
Pt #4 : Emotional Well-being : Visit 9	66.67
Pt #4 : Emotional Well-being : Visit 10	60
Pt #4 : Social Functioning : Visit 1	25
Pt #4 : Social Functioning : Visit 5	37.5
Pt #4 : Social Functioning : Visit 8	50
Pt #4 : Social Functioning : Visit 9	NA
Pt #4 : Social Functioning : Visit 10	50
Pt #4 : Pain : Visit 1	22.5
Pt #4 : Pain : Visit 5	20
Pt #4 : Pain : Visit 8	67.5
Pt #4 : Pain : Visit 9	NA
Pt #4 : Pain : Visit 10	55
Pt #4 : General Health : Visit 1	35
Pt #4 : General Health : Visit 5	35
Pt #4 : General Health : Visit 8	30
Pt #4 : General Health : Visit 9	40
Pt #4 : General Health : Visit 10	30
Pt #5: Physical Functioning : Visit 1	10
Pt #5: Physical Functioning : Visit 5	20
Pt #5: Physical Functioning : Visit 8	15
Pt #5: Physical Functioning : Visit 9	10
Pt #5: Physical Functioning : Visit 10	15
Pt #5: Role-physical : Visit 1	0
Pt #5: Role-physical : Visit 5	0
Pt #5: Role-physical : Visit 8	0
Pt #5: Role-physical : Visit 9	0
Pt #5: Role-physical : Visit 10	0
Pt #5: Role-emotional : Visit 1	33.33
Pt #5: Role-emotional : Visit 5	0
Pt #5: Role-emotional : Visit 8	33.33
Pt #5: Role-emotional : Visit 9	33.33
Pt #5: Role-emotional : Visit 10	33.33
Pt #5: Energy/fatigue : Visit 1	25
Pt #5: Energy/fatigue : Visit 5	30
Pt #5: Energy/fatigue : Visit 8	20
Pt #5: Energy/fatigue : Visit 9	0
Pt #5: Energy/fatigue : Visit 10	15
Pt #5: Emotional Well-being : Visit 1	72
Pt #5: Emotional Well-being : Visit 5	76
Pt #5: Emotional Well-being : Visit 8	68
Pt #5: Emotional Well-being : Visit 9	64
Pt #5: Emotional Well-being : Visit 10	68
Pt #5: Social Functioning : Visit 1	12.5
Pt #5: Social Functioning : Visit 5	50
Pt #5: Social Functioning : Visit 8	37.5
Pt #5: Social Functioning : Visit 9	12.5
Pt #5: Social Functioning : Visit 10	12.5
Pt #5: Pain : Visit 1	22.5
Pt #5: Pain : Visit 5	35
Pt #5: Pain : Visit 8	22.5
Pt #5: Pain : Visit 9	32.5
Pt #5: Pain : Visit 10	10
Pt #5: General Health : Visit 1	25
Pt #5: General Health : Visit 5	20
Pt #5: General Health : Visit 8	15
Pt #5: General Health : Visit 9	20
Pt #5: General Health : Visit 10	25
Pt #6: Physical Functioning : Visit 1	22.22
Pt #6: Physical Functioning : Visit 5	27.78
Pt #6: Physical Functioning : Visit 8	20
Pt #6: Physical Functioning : Visit 9	15
Pt #6: Physical Functioning : Visit 10	0
Pt #6: Role-physical : Visit 1	NA
Pt #6: Role-physical : Visit 5	NA
Pt #6: Role-physical : Visit 8	0
Pt #6: Role-physical : Visit 9	0
Pt #6: Role-physical : Visit 10	0
Pt #6: Role-emotional : Visit 1	NA
Pt #6: Role-emotional : Visit 5	NA
Pt #6: Role-emotional : Visit 8	0
Pt #6: Role-emotional : Visit 9	100
Pt #6: Role-emotional : Visit 10	33.3
Pt #6: Energy/fatigue : Visit 1	10
Pt #6: Energy/fatigue : Visit 5	10
Pt #6: Energy/fatigue : Visit 8	15
Pt #6: Energy/fatigue : Visit 9	10
Pt #6: Energy/fatigue : Visit 10	0
Pt #6: Emotional Well-being : Visit 1	46.67
Pt #6: Emotional Well-being : Visit 5	60
Pt #6: Emotional Well-being : Visit 8	64
Pt #6: Emotional Well-being : Visit 9	64
Pt #6: Emotional Well-being : Visit 10	36
Pt #6: Social Functioning : Visit 1	NA
Pt #6: Social Functioning : Visit 5	NA
Pt #6: Social Functioning : Visit 8	25
Pt #6: Social Functioning : Visit 9	37.5
Pt #6: Social Functioning : Visit 10	25
Pt #6: Pain : Visit 1	NA
Pt #6: Pain : Visit 5	NA
Pt #6: Pain : Visit 8	100
Pt #6: Pain : Visit 9	100
Pt #6: Pain : Visit 10	55
Pt #6: General Health : Visit 1	20
Pt #6: General Health : Visit 5	20
Pt #6: General Health : Visit 8	20
Pt #6: General Health : Visit 9	15
Pt #6: General Health : Visit 10	15
Pt #7: Physical Functioning : Visit 1	20
Pt #7: Physical Functioning : Visit 5	55
Pt #7: Physical Functioning : Visit 8	NA
Pt #7: Physical Functioning : Visit 9	NA
Pt #7: Physical Functioning : Visit 10	NA
Pt #7: Role-physical : Visit 1	100
Pt #7: Role-physical : Visit 5	25
Pt #7: Role-physical : Visit 8	NA
Pt #7: Role-physical : Visit 9	NA
Pt #7: Role-physical : Visit 10	NA
Pt #7: Role-emotional : Visit 1	100
Pt #7: Role-emotional : Visit 5	100
Pt #7: Role-emotional : Visit 8	NA
Pt #7: Role-emotional : Visit 9	NA
Pt #7: Role-emotional : Visit 10	NA
Pt #7: Energy/fatigue : Visit 1	65
Pt #7: Energy/fatigue : Visit 5	10
Pt #7: Energy/fatigue : Visit 8	NA
Pt #7: Energy/fatigue : Visit 9	NA
Pt #7: Energy/fatigue : Visit 10	NA
Pt #7: Emotional Well-being : Visit 1	72
Pt #7: Emotional Well-being : Visit 5	88
Pt #7: Emotional Well-being : Visit 8	NA
Pt #7: Emotional Well-being : Visit 9	NA
Pt #7: Emotional Well-being : Visit 10	NA
Pt #7: Social Functioning : Visit 1	50
Pt #7: Social Functioning : Visit 5	87.5
Pt #7: Social Functioning : Visit 8	NA
Pt #7: Social Functioning : Visit 9	NA
Pt #7: Social Functioning : Visit 10	NA
Pt #7: Pain : Visit 1	77.5
Pt #7: Pain : Visit 5	77.5
Pt #7: Pain : Visit 8	NA
Pt #7: Pain : Visit 9	NA
Pt #7: Pain : Visit 10	NA
Pt #7: General Health : Visit 1	30
Pt #7: General Health : Visit 5	35
Pt #7: General Health : Visit 8	NA
Pt #7: General Health : Visit 9	NA
Pt #7: General Health : Visit 10	NA
Pt #8: Physical Functioning : Visit 1	45
Pt #8: Physical Functioning : Visit 5	75
Pt #8: Physical Functioning : Visit 8	45
Pt #8: Physical Functioning : Visit 9	70
Pt #8: Physical Functioning : Visit 10	45
Pt #8 Role-physcial : Visit 1	0
Pt #8 Role-physcial : Visit 5	33.33
Pt #8 Role-physcial : Visit 8	66.67
Pt #8 Role-physcial : Visit 9	100
Pt #8 Role-physcial : Visit 10	100
Pt #8: Role-emotional : Visit 1	0
Pt #8: Role-emotional : Visit 5	50
Pt #8: Role-emotional : Visit 8	50
Pt #8: Role-emotional : Visit 9	45
Pt #8: Role-emotional : Visit 10	50
Pt #8: Energy/fatigue : Visit 1	40
Pt #8: Energy/fatigue : Visit 5	50
Pt #8: Energy/fatigue : Visit 8	50
Pt #8: Energy/fatigue : Visit 9	45
Pt #8: Energy/fatigue : Visit 10	50
Pt #8 : Emotional Well-being : Visit 1	52
Pt #8 : Emotional Well-being : Visit 5	60
Pt #8 : Emotional Well-being : Visit 8	52
Pt #8 : Emotional Well-being : Visit 9	92
Pt #8 : Emotional Well-being : Visit 10	92
Pt #8: Social Functioning : Visit 1	50
Pt #8: Social Functioning : Visit 5	50
Pt #8: Social Functioning : Visit 8	50
Pt #8: Social Functioning : Visit 9	75
Pt #8: Social Functioning : Visit 10	87.5
Pt #8 Pain : Visit 1	45
Pt #8 Pain : Visit 5	45
Pt #8 Pain : Visit 8	45
Pt #8 Pain : Visit 9	80
Pt #8 Pain : Visit 10	90
Pt #8: General Health : Visit 1	45
Pt #8: General Health : Visit 5	50
Pt #8: General Health : Visit 8	55
Pt #8: General Health : Visit 9	80
Pt #8: General Health : Visit 10	65
Pt #9: Physical Functioning : Visit 1	75
Pt #9: Physical Functioning : Visit 5	NA
Pt #9: Physical Functioning : Visit 8	70
Pt #9: Physical Functioning : Visit 9	70
Pt #9: Physical Functioning : Visit 10	80
Pt #9: Role-physical : Visit 1	0
Pt #9: Role-physical : Visit 5	NA
Pt #9: Role-physical : Visit 8	0
Pt #9: Role-physical : Visit 9	25
Pt #9: Role-physical : Visit 10	100
Pt #9: Role-emotional : Visit 1	100
Pt #9: Role-emotional : Visit 5	NA
Pt #9: Role-emotional : Visit 8	100
Pt #9: Role-emotional : Visit 9	100
Pt #9: Role-emotional : Visit 10	100
Pt #9: Energy/fatigue : Visit 1	70
Pt #9: Energy/fatigue : Visit 5	NA
Pt #9: Energy/fatigue : Visit 8	60
Pt #9: Energy/fatigue : Visit 9	70
Pt #9: Energy/fatigue : Visit 10	75
Pt #9: Emotional Well-being : Visit 1	84
Pt #9: Emotional Well-being : Visit 5	NA
Pt #9: Emotional Well-being : Visit 8	80
Pt #9: Emotional Well-being : Visit 9	92
Pt #9: Emotional Well-being : Visit 10	80
Pt #9: Social Functioning : Visit 1	75
Pt #9: Social Functioning : Visit 5	NA
Pt #9: Social Functioning : Visit 8	62.5
Pt #9: Social Functioning : Visit 9	87.5
Pt #9: Social Functioning : Visit 10	75
Pt #9: Pain : Visit 1	77.5
Pt #9: Pain : Visit 5	NA
Pt #9: Pain : Visit 8	45
Pt #9: Pain : Visit 9	77.5
Pt #9: Pain : Visit 10	67.5
Pt #9: General Health : Visit 1	70
Pt #9: General Health : Visit 5	NA
Pt #9: General Health : Visit 8	31.25
Pt #9: General Health : Visit 9	40
Pt #9: General Health : Visit 10	56.25
Pt #10: Physical Functioning : Visit 1	80
Pt #10: Physical Functioning : Visit 5	90
Pt #10: Physical Functioning : Visit 8	83.33
Pt #10: Physical Functioning : Visit 9	85
Pt #10: Physical Functioning : Visit 10	85
Pt #10: Role-physical : Visit 1	0
Pt #10: Role-physical : Visit 5	25
Pt #10: Role-physical : Visit 8	100
Pt #10: Role-physical : Visit 9	25
Pt #10: Role-physical : Visit 10	100
Pt #10: Role-emotional : Visit 1	100
Pt #10: Role-emotional : Visit 5	100
Pt #10: Role-emotional : Visit 8	100
Pt #10: Role-emotional : Visit 9	100
Pt #10: Role-emotional : Visit 10	100
Pt #10: Energy/fatigue : Visit 1	60
Pt #10: Energy/fatigue : Visit 5	75
Pt #10: Energy/fatigue : Visit 8	80
Pt #10: Energy/fatigue : Visit 9	65
Pt #10: Energy/fatigue : Visit 10	80
Pt #10: Emotional Well-being : Visit 1	88
Pt #10: Emotional Well-being : Visit 5	84
Pt #10: Emotional Well-being : Visit 8	84
Pt #10: Emotional Well-being : Visit 9	92
Pt #10: Emotional Well-being : Visit 10	92
Pt #10 : Social Functioning : Visit 1	87.5
Pt #10 : Social Functioning : Visit 5	87.5
Pt #10 : Social Functioning : Visit 8	87.5
Pt #10 : Social Functioning : Visit 9	75
Pt #10 : Social Functioning : Visit 10	87.5
Pt #10 Pain : Visit 1	100
Pt #10 Pain : Visit 5	77.5
Pt #10 Pain : Visit 8	77.5
Pt #10 Pain : Visit 9	77.5
Pt #10 Pain : Visit 10	100
Pt #10 Visit 1 : General Health : Visit 1	80
Pt #10 Visit 1 : General Health : Visit 5	65
Pt #10 Visit 1 : General Health : Visit 8	65
Pt #10 Visit 1 : General Health : Visit 9	65
Pt #10 Visit 1 : General Health : Visit 10	65
Pt #11 Visit 1 : Physical Functioning : Visit 1	15
Pt #11 Visit 1 : Physical Functioning : Visit 5	NA
Pt #11 Visit 1 : Physical Functioning : Visit 8	10
Pt #11 Visit 1 : Physical Functioning : Visit 9	5
Pt #11 Visit 1 : Physical Functioning : Visit 10	10
Pt #11 Visit 1 : Role-physical : Visit 1	25
Pt #11 Visit 1 : Role-physical : Visit 5	NA
Pt #11 Visit 1 : Role-physical : Visit 8	25
Pt #11 Visit 1 : Role-physical : Visit 9	0
Pt #11 Visit 1 : Role-physical : Visit 10	25
Pt #11 Visit 1 : Role-emotional : Visit 1	0
Pt #11 Visit 1 : Role-emotional : Visit 5	NA
Pt #11 Visit 1 : Role-emotional : Visit 8	100
Pt #11 Visit 1 : Role-emotional : Visit 9	0
Pt #11 Visit 1 : Role-emotional : Visit 10	66.67
Pt #11 Visit 1 : Energy/fatigue : Visit 1	30
Pt #11 Visit 1 : Energy/fatigue : Visit 5	NA
Pt #11 Visit 1 : Energy/fatigue : Visit 8	40
Pt #11 Visit 1 : Energy/fatigue : Visit 9	20
Pt #11 Visit 1 : Energy/fatigue : Visit 10	20
Pt #11 Emotional Well-being : Visit 1	60
Pt #11 Emotional Well-being : Visit 5	NA
Pt #11 Emotional Well-being : Visit 8	84
Pt #11 Emotional Well-being : Visit 9	60
Pt #11 Emotional Well-being : Visit 10	68
Pt #11 Social Functioning : Visit 1	50
Pt #11 Social Functioning : Visit 5	NA
Pt #11 Social Functioning : Visit 8	87.5
Pt #11 Social Functioning : Visit 9	37.5
Pt #11 Social Functioning : Visit 10	62.5
Pt #11 Visit 1 : Pain : Visit 1	0
Pt #11 Visit 1 : Pain : Visit 5	NA
Pt #11 Visit 1 : Pain : Visit 8	22.5
Pt #11 Visit 1 : Pain : Visit 9	10
Pt #11 Visit 1 : Pain : Visit 10	22.5
Pt #11 General Health : Visit 1	5
Pt #11 General Health : Visit 5	NA
Pt #11 General Health : Visit 8	15
Pt #11 General Health : Visit 9	10
Pt #11 General Health : Visit 10	15
Pt #12 Physical Functioning : Visit 1	35
Pt #12 Physical Functioning : Visit 5	50
Pt #12 Physical Functioning : Visit 8	NA
Pt #12 Physical Functioning : Visit 9	40
Pt #12 Physical Functioning : Visit 10	44.44
Pt #12 Role-physical : Visit 1	0
Pt #12 Role-physical : Visit 5	0
Pt #12 Role-physical : Visit 8	NA
Pt #12 Role-physical : Visit 9	75
Pt #12 Role-physical : Visit 10	0
Pt #12 Role-emotional : Visit 1	33.33
Pt #12 Role-emotional : Visit 5	100
Pt #12 Role-emotional : Visit 8	NA
Pt #12 Role-emotional : Visit 9	100
Pt #12 Role-emotional : Visit 10	100
Pt #12 Energy/fatigue : Visit 1	40
Pt #12 Energy/fatigue : Visit 5	60
Pt #12 Energy/fatigue : Visit 8	NA
Pt #12 Energy/fatigue : Visit 9	65
Pt #12 Energy/fatigue : Visit 10	70
Pt #12 Emotional Well-being : Visit 1	68
Pt #12 Emotional Well-being : Visit 5	80
Pt #12 Emotional Well-being : Visit 8	NA
Pt #12 Emotional Well-being : Visit 9	72
Pt #12 Emotional Well-being : Visit 10	80
Pt #12 Social Functioning : Visit 1	50
Pt #12 Social Functioning : Visit 5	87.5
Pt #12 Social Functioning : Visit 8	NA
Pt #12 Social Functioning : Visit 9	87.5
Pt #12 Social Functioning : Visit 10	87.5
Pt #12 Pain : Visit 1	77.5
Pt #12 Pain : Visit 5	55
Pt #12 Pain : Visit 8	NA
Pt #12 Pain : Visit 9	67.5
Pt #12 Pain : Visit 10	77.5
Pt #12 General Health : Visit 1	60
Pt #12 General Health : Visit 5	45
Pt #12 General Health : Visit 8	NA
Pt #12 General Health : Visit 9	50
Pt #12 General Health : Visit 10	55
Pt#13 Physical Functioning : Visit 1	20
Pt#13 Physical Functioning : Visit 5	NA
Pt#13 Physical Functioning : Visit 8	15
Pt#13 Physical Functioning : Visit 9	10
Pt#13 Physical Functioning : Visit 10	15
Pt #13 Role-physical : Visit 1	25
Pt #13 Role-physical : Visit 5	NA
Pt #13 Role-physical : Visit 8	0
Pt #13 Role-physical : Visit 9	0
Pt #13 Role-physical : Visit 10	0
Pt #13 Role-emotional : Visit 1	33.33
Pt #13 Role-emotional : Visit 5	NA
Pt #13 Role-emotional : Visit 8	0
Pt #13 Role-emotional : Visit 9	100
Pt #13 Role-emotional : Visit 10	100
Pt #13 Energy/fatigue : Visit 1	40
Pt #13 Energy/fatigue : Visit 5	NA
Pt #13 Energy/fatigue : Visit 8	25
Pt #13 Energy/fatigue : Visit 9	25
Pt #13 Energy/fatigue : Visit 10	10
Pt #13 Emotional Well-being : Visit 1	60
Pt #13 Emotional Well-being : Visit 5	NA
Pt #13 Emotional Well-being : Visit 8	60
Pt #13 Emotional Well-being : Visit 9	64
Pt #13 Emotional Well-being : Visit 10	72
Pt #13 Social Functioning : Visit 1	62.5
Pt #13 Social Functioning : Visit 5	NA
Pt #13 Social Functioning : Visit 8	62.5
Pt #13 Social Functioning : Visit 9	62.5
Pt #13 Social Functioning : Visit 10	62.5
Pt #13 Pain : Visit 1	67.5
Pt #13 Pain : Visit 5	NA
Pt #13 Pain : Visit 8	10
Pt #13 Pain : Visit 9	32.5
Pt #13 Pain : Visit 10	45
Pt #13 General Health : Visit 1	20
Pt #13 General Health : Visit 5	NA
Pt #13 General Health : Visit 8	10
Pt #13 General Health : Visit 9	15
Pt #13 General Health : Visit 10	15
Pt #14 Physical Functioning : Visit 1	80
Pt #14 Physical Functioning : Visit 5	NA
Pt #14 Physical Functioning : Visit 8	45
Pt #14 Physical Functioning : Visit 9	50
Pt #14 Physical Functioning : Visit 10	60
Pt #14 Role-physical : Visit 1	100
Pt #14 Role-physical : Visit 5	NA
Pt #14 Role-physical : Visit 8	0
Pt #14 Role-physical : Visit 9	0
Pt #14 Role-physical : Visit 10	50
Pt #14 Role-emotional : Visit 1	0
Pt #14 Role-emotional : Visit 5	NA
Pt #14 Role-emotional : Visit 8	0
Pt #14 Role-emotional : Visit 9	33.33
Pt #14 Role-emotional : Visit 10	100
Pt #14 Energy/fatigue : Visit 1	60
Pt #14 Energy/fatigue : Visit 5	NA
Pt #14 Energy/fatigue : Visit 8	50
Pt #14 Energy/fatigue : Visit 9	35
Pt #14 Energy/fatigue : Visit 10	75
Pt #14 Emotional Well-being : Visit 1	56
Pt #14 Emotional Well-being : Visit 5	NA
Pt #14 Emotional Well-being : Visit 8	64
Pt #14 Emotional Well-being : Visit 9	52
Pt #14 Emotional Well-being : Visit 10	92
Pt #14 Social Functioning : Visit 1	100
Pt #14 Social Functioning : Visit 5	NA
Pt #14 Social Functioning : Visit 8	62.5
Pt #14 Social Functioning : Visit 9	62.5
Pt #14 Social Functioning : Visit 10	62.5
Pt #14 Pain : Visit 1	100
Pt #14 Pain : Visit 5	NA
Pt #14 Pain : Visit 8	32.5
Pt #14 Pain : Visit 9	45
Pt #14 Pain : Visit 10	32.5
Pt #14 General Health : Visit 1	50
Pt #14 General Health : Visit 5	NA
Pt #14 General Health : Visit 8	50
Pt #14 General Health : Visit 9	40
Pt #14 General Health : Visit 10	60
Pt #15 Physical Functioning : Visit 1	10
Pt #15 Physical Functioning : Visit 5	NA
Pt #15 Physical Functioning : Visit 8	NA
Pt #15 Physical Functioning : Visit 9	5
Pt #15 Physical Functioning : Visit 10	11.11
Pt #15 Role-physical : Visit 1	0
Pt #15 Role-physical : Visit 5	NA
Pt #15 Role-physical : Visit 8	NA
Pt #15 Role-physical : Visit 9	0
Pt #15 Role-physical : Visit 10	25
Pt #15 Role-emotional : Visit 1	66.67
Pt #15 Role-emotional : Visit 5	NA
Pt #15 Role-emotional : Visit 8	NA
Pt #15 Role-emotional : Visit 9	66.67
Pt #15 Role-emotional : Visit 10	100
Pt #15 Energy/fatigue : Visit 1	0
Pt #15 Energy/fatigue : Visit 5	NA
Pt #15 Energy/fatigue : Visit 8	NA
Pt #15 Energy/fatigue : Visit 9	0
Pt #15 Energy/fatigue : Visit 10	0
Pt #15 Emotional Well-being : Visit 1	88
Pt #15 Emotional Well-being : Visit 5	NA
Pt #15 Emotional Well-being : Visit 8	NA
Pt #15 Emotional Well-being : Visit 9	88
Pt #15 Emotional Well-being : Visit 10	80
Pt #15 Social Functioning : Visit 1	37.5
Pt #15 Social Functioning : Visit 5	NA
Pt #15 Social Functioning : Visit 8	NA
Pt #15 Social Functioning : Visit 9	50
Pt #15 Social Functioning : Visit 10	50
Pt #15 Pain : Visit 1	NA
Pt #15 Pain : Visit 5	NA
Pt #15 Pain : Visit 8	NA
Pt #15 Pain : Visit 9	70
Pt #15 Pain : Visit 10	22.5
Pt #15 General Health : Visit 1	15
Pt #15 General Health : Visit 5	NA
Pt #15 General Health : Visit 8	NA
Pt #15 General Health : Visit 9	15
Pt #15 General Health : Visit 10	10
Pt #16 Physical Functioning : Visit 1	30
Pt #16 Physical Functioning : Visit 5	NA
Pt #16 Physical Functioning : Visit 8	NA
Pt #16 Physical Functioning : Visit 9	NA
Pt #16 Physical Functioning : Visit 10	NA
Pt #16 Role-physical : Visit 1	25
Pt #16 Role-physical : Visit 5	NA
Pt #16 Role-physical : Visit 8	NA
Pt #16 Role-physical : Visit 9	NA
Pt #16 Role-physical : Visit 10	NA
Pt #16 Role-emotional : Visit 1	0
Pt #16 Role-emotional : Visit 5	NA
Pt #16 Role-emotional : Visit 8	NA
Pt #16 Role-emotional : Visit 9	NA
Pt #16 Role-emotional : Visit 10	NA
Pt #16 Energy/fatigue : Visit 1	20
Pt #16 Energy/fatigue : Visit 5	NA
Pt #16 Energy/fatigue : Visit 8	NA
Pt #16 Energy/fatigue : Visit 9	NA
Pt #16 Energy/fatigue : Visit 10	NA
Pt #16 Emotional Well-being : Visit 1	48
Pt #16 Emotional Well-being : Visit 5	NA
Pt #16 Emotional Well-being : Visit 8	NA
Pt #16 Emotional Well-being : Visit 9	NA
Pt #16 Emotional Well-being : Visit 10	NA
Pt #16 Social Functioning : Visit 1	0
Pt #16 Social Functioning : Visit 5	NA
Pt #16 Social Functioning : Visit 8	NA
Pt #16 Social Functioning : Visit 9	NA
Pt #16 Social Functioning : Visit 10	NA
Pt #16 Pain : Visit 1	22.5
Pt #16 Pain : Visit 5	NA
Pt #16 Pain : Visit 8	NA
Pt #16 Pain : Visit 9	NA
Pt #16 Pain : Visit 10	NA
Pt #16 General Health : Visit 1	25
Pt #16 General Health : Visit 5	NA
Pt #16 General Health : Visit 8	NA
Pt #16 General Health : Visit 9	NA
Pt #16 General Health : Visit 10	NA
Pt #17 Physical Functioning : Visit 1	95
Pt #17 Physical Functioning : Visit 5	NA
Pt #17 Physical Functioning : Visit 8	88.89
Pt #17 Physical Functioning : Visit 9	85
Pt #17 Physical Functioning : Visit 10	NA
Pt #17 Role-physical : Visit 1	50
Pt #17 Role-physical : Visit 5	NA
Pt #17 Role-physical : Visit 8	100
Pt #17 Role-physical : Visit 9	75
Pt #17 Role-physical : Visit 10	NA
Pt #17 Role-emotional : Visit 1	66.67
Pt #17 Role-emotional : Visit 5	NA
Pt #17 Role-emotional : Visit 8	100
Pt #17 Role-emotional : Visit 9	100
Pt #17 Role-emotional : Visit 10	NA
Pt #17 Energy/fatigue : Visit 1	70
Pt #17 Energy/fatigue : Visit 5	NA
Pt #17 Energy/fatigue : Visit 8	40
Pt #17 Energy/fatigue : Visit 9	35
Pt #17 Energy/fatigue : Visit 10	NA
Pt #17 Emotional Well-being : Visit 1	96
Pt #17 Emotional Well-being : Visit 5	NA
Pt #17 Emotional Well-being : Visit 8	76
Pt #17 Emotional Well-being : Visit 9	76
Pt #17 Emotional Well-being : Visit 10	NA
Pt #17 Social Functioning : Visit 1	87.5
Pt #17 Social Functioning : Visit 5	NA
Pt #17 Social Functioning : Visit 8	50
Pt #17 Social Functioning : Visit 9	50
Pt #17 Social Functioning : Visit 10	NA
Pt #17 Pain : Visit 1	100
Pt #17 Pain : Visit 5	NA
Pt #17 Pain : Visit 8	100
Pt #17 Pain : Visit 9	75
Pt #17 Pain : Visit 10	NA
Pt #17 General Health : Visit 1	55
Pt #17 General Health : Visit 5	NA
Pt #17 General Health : Visit 8	70
Pt #17 General Health : Visit 9	55
Pt #17 General Health : Visit 10	NA

Adverse Events

Time Frame	Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Arm/Group Title	Bortezomib
Arm/Group Description	Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
All Cause Mortality
	Bortezomib
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Bortezomib
	Affected / at Risk (%)	# Events
Total	3/17 (17.6%)
Cardiac disorders
Myocardial Infarction	1/17 (5.9%)
Gastrointestinal disorders
Dehydration	1/17 (5.9%)
Infections and infestations
Varicella aoster virus/systemic inflammatory response	1/17 (5.9%)
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/17 (5.9%)
Other (Not Including Serious) Adverse Events
	Bortezomib
	Affected / at Risk (%)	# Events
Total	17/17 (100%)
Blood and lymphatic system disorders
Hemoglobin	2/17 (11.8%)
Lymphopenia	7/17 (41.2%)
Neutrophils/granulocytes (ANC/AGC)	1/17 (5.9%)
Platelets	4/17 (23.5%)
Edema: limb	4/17 (23.5%)
Cardiac disorders
Pain - Chest Wall	1/17 (5.9%)
Eye disorders
Dry eye syndrome	3/17 (17.6%)
Ocular/Visual - Other (Specify, Meibomitis)	2/17 (11.8%)
Vision-blurred vision	2/17 (11.8%)
Gastrointestinal disorders
Anorexia	2/17 (11.8%)
Constipation	3/17 (17.6%)
Diarrhea	6/17 (35.3%)
Dry mouth/salivary gland (xerostomia)	1/17 (5.9%)
Nausea	6/17 (35.3%)
Vomiting	1/17 (5.9%)
Pain - Abdomen NOS	1/17 (5.9%)
General disorders
Fatigue (asthenia, lethargy, malaise)	8/17 (47.1%)
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	3/17 (17.6%)
Insomnia	2/17 (11.8%)
Sweating (diaphoresis)	1/17 (5.9%)
Weight gain	1/17 (5.9%)
Weight loss	3/17 (17.6%)
Flu-like syndrome	3/17 (17.6%)
Infections and infestations
Infection - Systemic Inflammatory Response Syndrome	1/17 (5.9%)
Infection - pulmonary/upper respiratory - upper airway NOS	2/17 (11.8%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Nose	1/17 (5.9%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx	1/17 (5.9%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	1/17 (5.9%)
Viral hepatitis	1/17 (5.9%)
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)	1/17 (5.9%)
AST, SGOT(serum glutamic oxaloacetic transaminase)	3/17 (17.6%)
Albumin, serum-low (hypoalbuminemia)	2/17 (11.8%)
Calcium, serum-low (hypocalcemia)	3/17 (17.6%)
Creatinine	4/17 (23.5%)
Glucose, serum-high (hyperglycemia)	13/17 (76.5%)
Glucose, serum-low (hypoglycemia)	1/17 (5.9%)
Magnesium, serum-low (hypomagnesemia)	3/17 (17.6%)
Phosphate, serum-low (hypophosphatemia)	2/17 (11.8%)
Potassium, serum-high (hyperkalemia)	1/17 (5.9%)
Potassium, serum-low (hypokalemia)	2/17 (11.8%)
Sodium, serum-high (hypernatremia)	1/17 (5.9%)
Sodium, serum-low (hyponatremia)	5/17 (29.4%)
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	1/17 (5.9%)
Pain - Back	1/17 (5.9%)
Pain - Joint	1/17 (5.9%)
Nervous system disorders
Confusion	1/17 (5.9%)
Mood alteration - Anxiety	1/17 (5.9%)
Mood alteration - Depression	1/17 (5.9%)
Neuropathy: sensory	8/17 (47.1%)
Syncope (fainting)	1/17 (5.9%)
Pain - Head/headache	1/17 (5.9%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing	1/17 (5.9%)
Cough	8/17 (47.1%)
Dyspnea (shortness of breath)	3/17 (17.6%)
Hypoxia	2/17 (11.8%)
Nasal cavity/paranasal sinus reactions	1/17 (5.9%)
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)	1/17 (5.9%)
Dermatology/Skin - Other (Specify: skin lesion with some oozing)	1/17 (5.9%)
Dry skin	1/17 (5.9%)
Hyperpigmentation	1/17 (5.9%)
Pruritus/itching	1/17 (5.9%)
Rash/desquamation	1/17 (5.9%)

Limitations/Caveats

The study was closed before the accrual goal of 20 evaluable patients was reached due to slow accrual.

More Information

Certain Agreements

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

There is NOT 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.