Trial Outcomes & Findings for Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL) (NCT NCT00440726)

NCT ID: NCT00440726

Last Updated: 2020-02-19

Results Overview

Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutropenia, Fatigue, Electrolyte abnormalities, Hyper/Hypoglycemia, Nausea or Vomiting, AST/ALT/Bilirubin elevations that return to grade 1 by the time of the next course.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Beginning with the first dose of investigational product until 30 days following the last dose of bortezomib
• Results posted on: 2020-02-19

Participant Flow

31 unique individual participants were enrolled into the study collectively for both Phase 1 and 2. The breakdown is as follows: 10 in the Phase I study and 21 in the Phase II study. There was, however, one patient that started on Phase I, Cohort 2 that was later eligible and rolled into the Phase II study.

Participant milestones

Measure	Phase 1: Cohort 1 Bortezomib 1mg/m2/Day (Dose Level 1) The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.	Phase 1: Cohort 2 Bortezomib 1.3 mg/m2/Day (Dose Level 2) If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level.	Phase 2: Bortezomib 1.3 mg/m2/Day (Efficacy) After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.
Phase 1 STARTED	4	6	0
Phase 1 COMPLETED	3	5	0
Phase 1 NOT COMPLETED	1	1	0
Phase 2 STARTED	0	0	22
Phase 2 COMPLETED	0	0	20
Phase 2 NOT COMPLETED	0	0	2

Reasons for withdrawal

Measure	Phase 1: Cohort 1 Bortezomib 1mg/m2/Day (Dose Level 1) The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.	Phase 1: Cohort 2 Bortezomib 1.3 mg/m2/Day (Dose Level 2) If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level.	Phase 2: Bortezomib 1.3 mg/m2/Day (Efficacy) After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen.
Phase 1 Dose-Limiting Toxicity	0	1	0
Phase 1 Physician Decision	1	0	0
Phase 2 Death	0	0	1
Phase 2 Adverse Event	0	0	1

Baseline Characteristics

Patients in the dose escalation group were not stratified by lineage

Baseline characteristics by cohort

Measure	Phase 1 Dose Level 1 n=4 Participants Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11, dose-escalation Dexamethasone: Intravenous or oral administration for 14 days. PEG-asparaginase: Intramuscular injection Doxorubicin: Intravenous infusion Cytarabine: Intrathecal administration on day 1 Methotrexate: Intrathecal administration Vincristine: Intravenous push on days 1, 8, 15, 22 The starting dose level of bortezomib will be 1 mg/m2/day given 2x week for 2 weeks on Days 1, 4, 8, and 11. The dose will be escalated to 1.3 mg/m2/day assuming that the maximum tolerated dose (MTD) is not exceeded. If the MTD is exceeded, the study will back down to the next whole dose level.	Phase 1 Dose Level 2 n=6 Participants If the MTD is not exceeded at Dose Level 1, the next group of patients enrolled will escalate to Dose Level 2 of bortezomib at 1.3 mg/m2/day given on Days 1, 4, 8, and 11. This dose level is the highest possible dose level	Phase 2 Efficacy n=21 Participants After the MTD of bortezomib is defined with Phase 1, Phase 2 will enroll patients to receive bortezomib on Day 1, 4, 8 and 11 to evaluate activity of the regimen. Bortezomib (Velcade): Intravenous on days 1, 4, 8 and 11 at 1.3 mg/m2/day Dexamethasone: Intravenous or oral administration for 14 days. PEG-asparaginase: Intramuscular injection Doxorubicin: Intravenous infusion Cytarabine: Intrathecal administration on day 1 Methotrexate: Intrathecal administration Vincristine: Intravenous push on days 1, 8, 15, 22	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=4 Participants	6 Participants n=6 Participants	19 Participants n=21 Participants	29 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=4 Participants	0 Participants n=6 Participants	2 Participants n=21 Participants	2 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Sex: Female, Male Female	3 Participants n=4 Participants	5 Participants n=6 Participants	7 Participants n=21 Participants	15 Participants n=31 Participants
Sex: Female, Male Male	1 Participants n=4 Participants	1 Participants n=6 Participants	14 Participants n=21 Participants	16 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=4 Participants	1 Participants n=6 Participants	5 Participants n=21 Participants	9 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=4 Participants	5 Participants n=6 Participants	12 Participants n=21 Participants	18 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=6 Participants	4 Participants n=21 Participants	4 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=6 Participants	2 Participants n=21 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	4 Participants n=4 Participants	6 Participants n=6 Participants	19 Participants n=21 Participants	29 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=21 Participants	0 Participants n=31 Participants
Lineage B-precursor ALL	—	—	19 Participants n=21 Participants • Patients in the dose escalation group were not stratified by lineage	19 Participants n=21 Participants • Patients in the dose escalation group were not stratified by lineage
Lineage T-cell ALL	—	—	2 Participants n=21 Participants • Patients in the dose escalation group were not stratified by lineage	2 Participants n=21 Participants • Patients in the dose escalation group were not stratified by lineage
Prior Treatment Attempts One	1 Participants n=4 Participants	4 Participants n=6 Participants	0 Participants n=21 Participants	5 Participants n=31 Participants
Prior Treatment Attempts Two	3 Participants n=4 Participants	1 Participants n=6 Participants	16 Participants n=21 Participants	20 Participants n=31 Participants
Prior Treatment Attempts Three	0 Participants n=4 Participants	0 Participants n=6 Participants	5 Participants n=21 Participants	5 Participants n=31 Participants
Prior Treatment Attempts Four	0 Participants n=4 Participants	1 Participants n=6 Participants	0 Participants n=21 Participants	1 Participants n=31 Participants
Previous Bone Marrow Transplant None	—	—	17 Participants n=21 Participants • Patients in the dose escalation group not stratified by previous BM transplant.	17 Participants n=21 Participants • Patients in the dose escalation group not stratified by previous BM transplant.
Previous Bone Marrow Transplant Yes	—	—	4 Participants n=21 Participants • Patients in the dose escalation group not stratified by previous BM transplant.	4 Participants n=21 Participants • Patients in the dose escalation group not stratified by previous BM transplant.
Bone Marrow M3 at study entry	—	—	21 Participants n=21 Participants • Patients in the dose escalation group not stratified by leukemic blast status	21 Participants n=21 Participants • Patients in the dose escalation group not stratified by leukemic blast status

PRIMARY outcome

Timeframe: Beginning with the first dose of investigational product until 30 days following the last dose of bortezomib

Toxicity will be graded using the CTCAE criteria, version 3.0. Dose-limiting toxicity will be defined as any of the following events that are deemed by the investigator as possibly, probably or definitely attributable to bortezomib: Grade 3 or 4 Sensory Neuropathy; Grade 3 or 4 Neuropathic pain (Neuralgia or peripheral nerve) lasting longer than 24 hours despite medical intervention; Marrow hypoplasia, which continues 6 weeks from the start of each course (less than 10% cellularity); and Grade 4 Non-Hematologic Toxicity excluding the following: Infection (septic shock, typhlitis), Fever/Neutropenia, Fatigue, Electrolyte abnormalities, Hyper/Hypoglycemia, Nausea or Vomiting, AST/ALT/Bilirubin elevations that return to grade 1 by the time of the next course.

Outcome measures

Measure	Ph 1, Dose Level 1 (1 mg/m2) n=4 Participants Phase 1 patients receiving 1 mg/m2 dose of bortezomib	Ph 1, Dose Level 2 (1.3 mg/m2) n=6 Participants Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib	Ph 2 T-Cell ALL Patients Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
Occurrence of a Dose-Limiting Toxicity (Phase 1) DLT	0 Participants	1 Participants	—
Occurrence of a Dose-Limiting Toxicity (Phase 1) No DLT	4 Participants	5 Participants	—

PRIMARY outcome

Timeframe: Day 29 of Course 1

Population: One Ph 1 patient received incorrect doses of Dexamethasone, so not evaluable for response. One Phase 2 patient achieved BM M1 but was treated with additional chemotherapy before peripheral recovery, so response to protocol treatment could not be evaluated.

• Complete Remission (CR): M1 (< 5% blasts) BM with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC>750/uL and platelet count >75 000/uL);
• Complete Remission without Platelet Recovery (CRp): M1 BM with no circulating blasts or extramedullary disease and recovery of ANC (>750/uL) but insufficient recovery of platelets (<75 000/uL).
• Partial Remission (PR): the disappearance of circulating blasts and achievement of M2 (5%-25% blasts) marrow status, without new sites of extramedullary disease, and with recovery of ANC (>750/uL).
• Stable disease (SD): not satisfying the criterion for progressive disease (PD), or a recovery of ANC (>750/uL) but fails to qualify for CR, CRp, or PR.
• Progressive Disease (PD): increase of at least 25% in the absolute number of circulating leukemia cells, development of new sites of extramedullary disease, or other lab or clinical evidence of PD, with or without recovery of ANC or platelets.

Outcome measures

Measure	Ph 1, Dose Level 1 (1 mg/m2) n=9 Participants Phase 1 patients receiving 1 mg/m2 dose of bortezomib	Ph 1, Dose Level 2 (1.3 mg/m2) n=19 Participants Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib	Ph 2 T-Cell ALL Patients n=2 Participants Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
Achievement of Complete Remission (CR) CR	6 Participants	14 Participants	0 Participants
Achievement of Complete Remission (CR) CRp	0 Participants	2 Participants	0 Participants
Achievement of Complete Remission (CR) SD/PD	1 Participants	0 Participants	2 Participants
Achievement of Complete Remission (CR) BM-CR, CNS-SD	1 Participants	0 Participants	0 Participants
Achievement of Complete Remission (CR) Death	1 Participants	3 Participants	0 Participants

POST_HOC outcome

Timeframe: Day 29 of Course 1

Population: All patients who enrolled and treated under Phase 2 will be evaluated at the end of Course 1 for treatment response as indicated by measure of bone marrow (M1, M2, or M3) or patient survival if death occurred.

M1: Less than 5% blasts in a bone marrow aspirate and at least 200 cells counted.

M2: 5-25% blasts in a bone marrow aspirate with at least 200 cells counted. M3: Greater than 25% blasts in a bone marrow aspirate with at least 200 cells counted.

Outcome measures

Measure	Ph 1, Dose Level 1 (1 mg/m2) n=20 Participants Phase 1 patients receiving 1 mg/m2 dose of bortezomib	Ph 1, Dose Level 2 (1.3 mg/m2) n=2 Participants Phase 1 patients receiving 1.3 mg/m2 dose of bortezomib	Ph 2 T-Cell ALL Patients Patients enrolled into the Phase 2 portion of the study having T-Cell ALL
Bone Marrow Response M1	17 Participants	0 Participants	—
Bone Marrow Response M2/M3	0 Participants	2 Participants	—
Bone Marrow Response Death	3 Participants	0 Participants	—

Adverse Events

1 mg/m2 Dose Group

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

1.3 mg/m2 Dose Group

Serious events: 17 serious events

Other events: 27 other events

Deaths: 5 deaths

Serious adverse events

Measure	1 mg/m2 Dose Group n=4 participants at risk Patients receiving a 1 mg/m2 dose of bortezomib (known as Dose Level 1 in the Phase 1 portion). All patients in this group were from the Phase 1 portion of the study.	1.3 mg/m2 Dose Group n=27 participants at risk Patients receiving a 1.3 mg/m2 dose of bortezomib (known as Dose Level 2 in the Phase 1 portion). This group includes patients from both the Phase 1 and Phase 2 portions of the study.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood bilirubin increased	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Bone marrow depression NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Caecitis	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Vascular disorders Cerebral ischaemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Psychiatric disorders Confusion	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Depressed level of consciousness	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Diarrhea NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Encephalopathy	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Febrile neutropenia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hyperglycemia NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Vascular disorders Hypertension	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Vascular disorders Hypotension NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ Gr 3/4 ANC, Blood	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	29.6% 8/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ Gr 3/4 ANC, Brain	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ Gr 3/4 ANC, Skin	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ norm ANC, Blood	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ unk ANC, Mucosa	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection-Other	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Lipase increased	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Neutrophil count	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Platelet count decreased	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Pneumonia NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Syncope	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.

Other adverse events

Measure	1 mg/m2 Dose Group n=4 participants at risk Patients receiving a 1 mg/m2 dose of bortezomib (known as Dose Level 1 in the Phase 1 portion). All patients in this group were from the Phase 1 portion of the study.	1.3 mg/m2 Dose Group n=27 participants at risk Patients receiving a 1.3 mg/m2 dose of bortezomib (known as Dose Level 2 in the Phase 1 portion). This group includes patients from both the Phase 1 and Phase 2 portions of the study.
Gastrointestinal disorders Abdominal pain NOS	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	29.6% 8/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Activated partial thromboplastin time prolonged	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Alanine aminotransferase increased	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	70.4% 19/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Aspartate aminotransferase increased	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	63.0% 17/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	25.9% 7/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood amylase increased	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood bicarbonate decreased	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood bilirubin increased	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	25.9% 7/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood creatinine increased	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	14.8% 4/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Blood fibrinogen	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	14.8% 4/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Clostridial infection NOS	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Constipation	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	22.2% 6/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Convulsions NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Endocrine disorders Cushingoid	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Psychiatric disorders Depression	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Skin and subcutaneous tissue disorders Dermatology-Other	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Diarrhea NOS	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	29.6% 8/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Dizziness	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	14.8% 4/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Edema: limb	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Electrocardiogram QT prolonged	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	14.8% 4/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Fatigue	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	22.2% 6/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Febrile neutropenia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Hemoglobin	100.0% 4/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	74.1% 20/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Headache	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Hepatobiliary disorders Hepatobiliary/Pancreas-Other	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypercalcemia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hyperglycemia NOS	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	66.7% 18/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	33.3% 9/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypermagnesemia	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	18.5% 5/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Vascular disorders Hypertension	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	25.9% 7/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypertriglyceridemia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	85.2% 23/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypocalcemia	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	74.1% 20/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypoglycemia NOS	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	29.6% 8/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypokalaemia	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	40.7% 11/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	14.8% 4/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hyponatremia	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	77.8% 21/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Metabolism and nutrition disorders Hypophosphatemia	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	51.9% 14/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Hypotension NOS	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	25.9% 7/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Hypothermia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Implant site infection	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection w/ Gr 3/4 ANC, Blood	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Infections and infestations Infection-Other	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Leukopenia NOS	100.0% 4/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	81.5% 22/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Lipase increased	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Lymphopenia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	18.5% 5/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Metabolic/Lab-Other	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Myalgia	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Nausea	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	29.6% 8/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Neutrophil count	100.0% 4/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	44.4% 12/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Oral pain	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Pain NOS	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Pain, External ear	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Pain-Other	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	22.2% 6/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Pancreatitis NOS	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Blood and lymphatic system disorders Platelet count decreased	75.0% 3/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	77.8% 21/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Proctalgia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	0.00% 0/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Investigations Prothrombin time prolonged	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	22.2% 6/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Pyrexia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	18.5% 5/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
General disorders Rigors	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Cardiac disorders Sinus bradycardia	25.0% 1/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	3.7% 1/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Stomatitis	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	11.1% 3/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Nervous system disorders Tremor	0.00% 0/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	7.4% 2/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.
Gastrointestinal disorders Vomiting NOS	50.0% 2/4 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.	22.2% 6/27 • 60 days, beginning with the first dose of investigational product until 30 days following the last dose of bortezomib The definition of adverse event used for data collection does not differ from that in the clinicaltrials.gov Definitions. For the purpose of reporting SAEs, all Grade 3 and 4 toxicities (CTCAE) are reported in this study record. Patients were evaluated regularly by the treating physician.

Additional Information

Peggy Romano, BA, CCRP

Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles

Phone: 323-361-5505

Email: promano@chla.usc.edu

Results disclosure agreements

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

Restriction type: GT60