Trial Outcomes & Findings for Study of Bortezomib in Combination With Cyclophosphamide and Rituximab (NCT NCT00958256)
NCT ID: NCT00958256
Last Updated: 2015-04-13
Results Overview
Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Evaluation of disease after 2 cycles (approximately 6 weeks).
Results posted on
2015-04-13
Participant Flow
Recruitment Period: August 5, 2009 to March 28, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Of the 22 participants enrolled, one participant was excluded from the trial before treatment.
Participant milestones
| Measure |
Bortezomib With Cyclophosphamide and Rituximab
Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Bortezomib With Cyclophosphamide and Rituximab
Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Study of Bortezomib in Combination With Cyclophosphamide and Rituximab
Baseline characteristics by cohort
| Measure |
Bortezomib With Cyclophosphamide and Rituximab
n=21 Participants
Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluation of disease after 2 cycles (approximately 6 weeks).Population: Twenty-one patients were evaluable for response assessment (100%), of whom 16 responded (76%) thus reflected are the percentage of responses to total responders (i.e. 11 (52%) of total evaluable achieved a complete response).
Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.
Outcome measures
| Measure |
Bortezomib With Cyclophosphamide and Rituximab
n=21 Participants
Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
|
|---|---|
|
Response Rate
Complete Response (CR)
|
52 percentage of participants
|
|
Response Rate
Partial Response (PR)
|
0 percentage of participants
|
|
Response Rate
Progressive Disease (PD)
|
19 percentage of participants
|
|
Response Rate
Stable Disease (SD)
|
5 percentage of participants
|
Adverse Events
Bortezomib With Cyclophosphamide and Rituximab
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bortezomib With Cyclophosphamide and Rituximab
n=21 participants at risk
Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
4/21 • Number of events 4 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
33.3%
7/21 • Number of events 13 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
57.1%
12/21 • Number of events 22 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Immune system disorders
Allergic rhinitis
|
28.6%
6/21 • Number of events 7 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Anorexia
|
19.0%
4/21 • Number of events 4 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Psychiatric disorders
Anxiety
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
52.4%
11/21 • Number of events 21 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Cardiac disorders
Atrial tachycardia
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Bilirubin increased
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Blood glucose increased
|
85.7%
18/21 • Number of events 55 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Blood uric acid increased
|
52.4%
11/21 • Number of events 55 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.8%
1/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Bruising
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Cardiac disorders
Cardiac General (Other)
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Chest wall pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Constipation
|
47.6%
10/21 • Number of events 12 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.1%
8/21 • Number of events 8 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
23.8%
5/21 • Number of events 10 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Dehydration
|
9.5%
2/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (Other)
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
7/21 • Number of events 8 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Eye disorders
Dry eye syndrome
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.8%
5/21 • Number of events 6 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
7/21 • Number of events 8 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Ear and labyrinth disorders
Ear pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Edema limbs
|
23.8%
5/21 • Number of events 6 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Fatigue
|
76.2%
16/21 • Number of events 20 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Infections and infestations
Febrile neutropenia
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Investigations
Fever
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Gastrointestinal (Other)
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
90.5%
19/21 • Number of events 71 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.8%
1/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Leukopenia
|
81.0%
17/21 • Number of events 125 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
57.1%
12/21 • Number of events 76 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Nervous system disorders
Memory impairment
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory (Other)
|
95.2%
20/21 • Number of events 64 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
2/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.8%
1/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (Other)
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Nausea
|
76.2%
16/21 • Number of events 18 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
90.5%
19/21 • Number of events 108 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Eye disorders
Ocular/Visual (Other)
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Oral pain
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Pain
|
14.3%
3/21 • Number of events 4 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
General disorders
Pain (Other)
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
7/21 • Number of events 7 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.8%
1/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
21/21 • Number of events 148 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Infections and infestations
Pneumothorax
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
47.6%
10/21 • Number of events 28 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum cacium decreased
|
42.9%
9/21 • Number of events 26 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum glucose decrease
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
33.3%
7/21 • Number of events 13 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
14.3%
3/21 • Number of events 4 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
28.6%
6/21 • Number of events 11 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Metabolism and nutrition disorders
Serun potassium decreased
|
14.3%
3/21 • Number of events 3 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Nervous system disorders
Tremor
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
9.5%
2/21 • Number of events 2 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 4 • Adverse event collection performed with each cycle of chemotherapy every 21 days, up to 8 cycles with those who received at least one cycle considered assessable for adverse events. Overall study period: August 2009 to March 19, 2014.
|
Additional Information
Jorge Romaguera, MD/Professor, Lymphoma/Myeloma
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place