Trial Outcomes & Findings for Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma (NCT NCT00998010)

NCT ID: NCT00998010

Last Updated: 2020-08-28

Results Overview

Estimate the overall survival in subjects with newly-diagnosed glioblastoma (GBM) treated with bortezomib/temozolomide/radiation followed by bortezomib/temozolomide for 24 cycles until progression is detected or for up to 24 cycles (\~2 years).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2020-08-28

Participant Flow

Recruitment period: 10/03/2011 - 4/17/2015 Location: University of California at Los Angeles, Columbia University, New York.

There are no pre-assignment details to describe.

Participant milestones

Measure	Experimental Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Baseline characteristics by cohort

Measure	Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigrays (cGy) daily doses to a total dose of 6000 cGy.
Age, Continuous Age Range	57 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: From completion of radiation treatment to tumor progression

Estimate the overall survival in subjects with newly-diagnosed glioblastoma (GBM) treated with bortezomib/temozolomide/radiation followed by bortezomib/temozolomide for 24 cycles until progression is detected or for up to 24 cycles (~2 years).

Outcome measures

Measure

Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.

Overall Survival

19.1 months Interval 6.7 to 31.4

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Follow-up phase · Grade 3 toxicity	0 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Radiotherapy phase · Grade 3 toxicity	6 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Radiotherapy phase · Grade 4 Toxicity	1 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Radiotherapy phase · < Grade 3 Toxicity	17 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Post Radiotherapy phase · Grade 3 toxicity	7 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Post Radiotherapy phase · Grade 4 Toxicity	0 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Post Radiotherapy phase · < Grade 3 Toxicity	17 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Follow-up phase · Grade 4 Toxicity	0 Participants
Toxicity Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3. Follow-up phase · < Grade 3 Toxicity	24 Participants

SECONDARY outcome

Timeframe: From the completion of radiation treatment to tumor progression

Population: From the completion of radiation treatment to tumor progression

Median time to tumor progression. Because many newly-diagnosed patients are likely not to have evaluable disease due to gross total resections. A 7-point scale was used to guide Magnetic resonance imaging (MRI) assessment to determine progression in this study. A -2 or -3 assessment will be taken as progression.

The 7-point scale is listed below. complete resolution of tumor: 3 tumor definitely smaller: 2 tumor probably smaller: 1 tumor unchanged: 0 tumor probably worse: -1 tumor definitely worse: -2 new lesion: -3

Outcome measures

Measure

Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.

Time to Progression

6.2 months Interval 3.7 to 8.8

SECONDARY outcome

Timeframe: 1 year

Population: 12 months from completion of radiation treatment to tumor progression.

Overall Survival at 12 months from completion of radiation treatment

Outcome measures

Measure

Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.

Survival at 1 Year

87.5 percentage of participants Interval 66.1 to 95.8

SECONDARY outcome

Timeframe: at 6, 12, 18 and 24 months from completion of radiation treatment.

Population: Outcome was not analyzed separately, MRI and Neurological exam were to determine the progression status, and finally reflected as Progression Free Survival and Overall Survival

MRI will be done 2 weeks after completion of radiation and then every 8 weeks. Neurologic exam to be performed every 2 weeks during radiation therapy, then every every 4 weeks after radiation is completed.

Outcome measures

Measure	Experimental n=24 Participants Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.
Tumor Progression as Assessed by Magnetic Resonance Imaging (MRI) and Neurologic Exam Progression Free Survival rate at 18 months	25.0 percentage of participants Interval 10.2 to 43.1
Tumor Progression as Assessed by Magnetic Resonance Imaging (MRI) and Neurologic Exam Progression Free Survival rate at 6 months	54.2 percentage of participants Interval 32.7 to 71.4
Tumor Progression as Assessed by Magnetic Resonance Imaging (MRI) and Neurologic Exam Progression Free Survival rate at 12 months	29.2 percentage of participants Interval 13.0 to 47.6
Tumor Progression as Assessed by Magnetic Resonance Imaging (MRI) and Neurologic Exam Progression Free Survival rate at 24 moths	25 percentage of participants Interval 10.2 to 43.1

Adverse Events

Experimental

Serious events: 5 serious events

Other events: 24 other events

Deaths: 15 deaths

Serious adverse events

Measure	Experimental n=24 participants at risk Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Infections and infestations Shingles	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Hydrocephalus	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Craniotomy	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Respiratory, thoracic and mediastinal disorders Pullmonary embolism	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.

Other adverse events

Measure	Experimental n=24 participants at risk Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36, and 39 and oral temozolomide on days 1-42.Patients undergo external-beam fractionated regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.2-6 weeks after radiotherapy, patients receive bortezomib IV on days 1, 4, 8, and 11 and oral temozolomide on days 1-5.Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. bortezomib + temozolomide+ radiation therapy: Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200cGy daily doses to a total dose of 6000 cGy.
Blood and lymphatic system disorders Neutropenia	25.0% 6/24 • Number of events 30 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders lymphopenia	58.3% 14/24 • Number of events 107 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Encephalopathy (elevated ammonia)	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Vasogenic edema	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Fatigue	70.8% 17/24 • Number of events 21 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Fever	16.7% 4/24 • Number of events 5 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Malaise	4.2% 1/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Weight Loss	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Weight gain	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Insomnia	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Hypersomnia	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Chills	12.5% 3/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Increased appetite	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Injection site reaction	54.2% 13/24 • Number of events 13 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Skin Rash	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders skin rash-Radiodermatitis	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Skin rash- diffuse	12.5% 3/24 • Number of events 5 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Wound complication	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Pruritus	25.0% 6/24 • Number of events 8 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Other-Blepharitis	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders Anemia	37.5% 9/24 • Number of events 36 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders Leukocytopenia	37.5% 9/24 • Number of events 44 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders Thrombocytopenia	29.2% 7/24 • Number of events 10 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Alopecia	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders other- Skin Tears L. Forearm L. Peritibial region	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders skin rash-Periorbital	4.2% 1/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Dry Skin	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders skin rash (bactrim allergy)	8.3% 2/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders Skin Rash/acne	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Skin and subcutaneous tissue disorders bruising Ecchymosis	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Endocrine disorders Cushingoid appearance	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Eye disorders Ocular/ chalazion	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Eye disorders Ocular/visual Xerophtalmia/dry eyes	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Eye disorders Ocular/visual Blurred vision	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Poor Appetite/anorexia	25.0% 6/24 • Number of events 7 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Nausea	45.8% 11/24 • Number of events 14 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Vomiting	25.0% 6/24 • Number of events 9 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Dehydration	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Bloating/Hemorrhoids	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Flatulence	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Constipation	33.3% 8/24 • Number of events 10 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Gastrointestinal disorders Diarrhea	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Cardiac disorders Cardiac/general Hypertension	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Cardiac disorders Cardiac/general Hypotension	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Cardiac disorders Cardiac arrhythmia Tachycardia	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Immune system disorders Allergy/immunology Allergic rhinitis (nasal congestion )	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Infections and infestations Other-Pelvic infection	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Infections and infestations Oral thrush	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Infections and infestations Ear Infection/otitis media	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Eye disorders Conjunctivitis	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Eye disorders Stye on LL conjunctival border	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Infections and infestations Other-Herpes zoster infection	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders Lymphatics Limb edema	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Blood and lymphatic system disorders Lymphatics/edema Swelling on the lips	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Psychiatric disorders Personality/behavioral change	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Hypoglycemia	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated bilirubin	16.7% 4/24 • Number of events 16 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated ALP	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated ALT	20.8% 5/24 • Number of events 6 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated AST	16.7% 4/24 • Number of events 5 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated LDH	4.2% 1/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Hyperglicemia	16.7% 4/24 • Number of events 8 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Hyponatremia	4.2% 1/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated CREATINIE	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Decrease GFR	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Hypercholesterolemia	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Metabolism and nutrition disorders Elevated triglycerides	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Cramping	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders meniscal tear	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Pain	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Gait/Walking	12.5% 3/24 • Number of events 5 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Seizure	20.8% 5/24 • Number of events 11 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Tremor	8.3% 2/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Mood alteration	25.0% 6/24 • Number of events 11 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Confusion	20.8% 5/24 • Number of events 6 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Memory impairment	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Cognitive disturbance	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Motor neuropathy	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Sensory neuropathy	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Hydrocephalus	8.3% 2/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Paresthesia	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Motor weakness	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Falls	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Positional Dizziness	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders voice changes Dysarthria	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Alexia	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Lack of motivation	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Difficulty with concentration	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders extrapyramidal involuntary Movement Restless legs	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders other- Abulia	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Aphasia	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders dysphagia	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Lethargy	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Olecranon bursitis	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Dental: periodontal disease-sensitivity	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Nervous system disorders Headache	58.3% 14/24 • Number of events 23 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Knee pain	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Other-VZV infection related pain	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
General disorders Cramping/Bilateral Lower Extremities	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Back	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Musculoskeletal and connective tissue disorders Nose	12.5% 3/24 • Number of events 3 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Respiratory, thoracic and mediastinal disorders Dispnea	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Respiratory, thoracic and mediastinal disorders cough	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Respiratory, thoracic and mediastinal disorders other-Upper respiratory tract infection	16.7% 4/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Renal and urinary disorders Urinary retention	4.2% 1/24 • Number of events 1 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Renal and urinary disorders Urinary incontinence	8.3% 2/24 • Number of events 2 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.
Renal and urinary disorders Urinary urgency	12.5% 3/24 • Number of events 4 • Adverse Events data was collected up to 2 years from the completion of radiation treatment Systemic adverse event assessment occurred weekly during radiation treatment period, and on Day 1 and Day 21 of each 28-day maintenance treatment cycle, and within 30 days after administration of the last dost of study drug bortezomib.

Additional Information

Mark Glover

University of California at Los Angeles

Phone: (310) 794-8742

Email: mglover@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place