Trial Outcomes & Findings for Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma (NCT NCT01281917)

NCT ID: NCT01281917

Last Updated: 2019-12-13

Results Overview

The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2019-12-13

Participant Flow

Patients with relapsed or refractory B-cell NHL were enrolled from 10 sites within the Wisconsin Oncology Network (WON) between May 2011 and May 2013.

Forty participants were enrolled from 10 sites within the Wisconsin Oncology Network (WON) over 2 years. One participant withdrew consent immediately after enrollment and was never treated. Therefore, results are reported on the remaining 39 participants.

Participant milestones

Participant milestones
Measure	Velcade Plus Temsirolimus Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Velcade Plus Temsirolimus Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
Number of prior treatments	4 Prior treatments n=5 Participants
Histology DLBCL	18 Participants n=5 Participants
Histology Follicular lymphoma	9 Participants n=5 Participants
Histology Mantle cell lymphoma	7 Participants n=5 Participants
Histology Small lymphocytic lymphoma	3 Participants n=5 Participants
Histology Marginal zone lymphoma	2 Participants n=5 Participants
ECOG Performance Status 0	17 Participants n=5 Participants
ECOG Performance Status 1	16 Participants n=5 Participants
ECOG Performance Status 2	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Overall Response Rate	31 Percentage of participants Interval 17.0 to 46.6

PRIMARY outcome

Timeframe: Up to 60 months

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Progression Free Survival	4.7 Months Interval 2.9 to 7.8

SECONDARY outcome

Timeframe: Up to 36 months

Safety of the regimen will be measured by frequency and severity of adverse events.

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Safety of This Regimen Grade 3 Adverse Events	31 Participants
Safety of This Regimen Grade 4 Adverse Events	2 Participants
Safety of This Regimen No Grade 3/4 Adverse Events	6 Participants

SECONDARY outcome

Timeframe: Up to 60 months

The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Complete Response Rate	3 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Tolerability of the Regimen Discontinued study due to an adverse event	5 Participants
Tolerability of the Regimen Continued study	34 Participants

SECONDARY outcome

Timeframe: Up to 60 months

Duration of Response is how long a response to therapy is held before a subject has progressive disease.

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Duration of Response	7 months Interval 5.2 to 999.0

SECONDARY outcome

Timeframe: Up to 60 months

Length of time from enrollment until death.

Outcome measures

Outcome measures
Measure	Velcade Plus Temsirolimus n=39 Participants Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Overall Survival	14.1 Months Interval 5.0 to 999.0

Adverse Events

Velcade Plus Temsirolimus

Serious events: 18 serious events

Other events: 35 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Velcade Plus Temsirolimus n=39 participants at risk Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Renal and urinary disorders Urinary Tract Infection	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Renal and urinary disorders Acute Kidney Injury	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Constipation	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Diarrhea	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Fatigue	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Fever	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Cardiac disorders Heart Failure	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Sepsis	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Cardiac disorders Atrial flutter	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Edema limbs	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypercalcemia	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Ileus	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Lung infection	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Palsy (right side of face)	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Reproductive system and breast disorders Scrotal Pain	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Seizure	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Blood and lymphatic system disorders Shaking chills/non neutropenic fever and chills	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Small intestinal obstruction	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Syncope	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Blood and lymphatic system disorders Temsirolimus	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Vascular disorders Thrombolic Event	2.6% 1/39 • Number of events 1 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.

Other adverse events

Other adverse events
Measure	Velcade Plus Temsirolimus n=39 participants at risk Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Investigations Platelet count decreased	61.5% 24/39 • Number of events 82 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Fatigue	51.3% 20/39 • Number of events 36 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Neutrophil count decreased	46.2% 18/39 • Number of events 46 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Nausea	46.2% 18/39 • Number of events 27 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Diarrhea	43.6% 17/39 • Number of events 32 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Anorexia	41.0% 16/39 • Number of events 22 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Blood and lymphatic system disorders Anemia	33.3% 13/39 • Number of events 29 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Peripheral sensory neuropathy	30.8% 12/39 • Number of events 18 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnea	30.8% 12/39 • Number of events 14 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Vomiting	28.2% 11/39 • Number of events 15 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Chills	28.2% 11/39 • Number of events 20 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Edema limbs	28.2% 11/39 • Number of events 18 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations White blood cell decreased	25.6% 10/39 • Number of events 28 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Constipation	25.6% 10/39 • Number of events 12 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Dizziness	25.6% 10/39 • Number of events 13 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Mucositis oral	23.1% 9/39 • Number of events 12 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Lymphocyte count decreased	20.5% 8/39 • Number of events 19 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Abdominal pain	20.5% 8/39 • Number of events 11 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Headache	20.5% 8/39 • Number of events 8 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	20.5% 8/39 • Number of events 8 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Skin and subcutaneous tissue disorders Pruritus	20.5% 8/39 • Number of events 11 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.5% 8/39 • Number of events 9 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Insomnia	20.5% 8/39 • Number of events 10 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Fever	17.9% 7/39 • Number of events 9 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	15.4% 6/39 • Number of events 8 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Infections and infestations - Other	15.4% 6/39 • Number of events 7 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Vascular disorders Hypotension	15.4% 6/39 • Number of events 7 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Dysgeusia	12.8% 5/39 • Number of events 5 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	12.8% 5/39 • Number of events 7 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Pain in extremity	12.8% 5/39 • Number of events 12 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Productive cough	12.8% 5/39 • Number of events 6 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Sore throat	12.8% 5/39 • Number of events 5 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Dry mouth	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Dysphagia	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Oral pain	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Dehydration	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypoalbuminemia	10.3% 4/39 • Number of events 6 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypokalemia	10.3% 4/39 • Number of events 8 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Myalgia	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.3% 4/39 • Number of events 5 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Injury, poisoning and procedural complications Bruising	10.3% 4/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Creatinine increased	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Investigations - Other, specify	7.7% 3/39 • Number of events 9 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Weight loss	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Abdominal distension	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Bloating	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Ataxia	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Nervous system disorders - Other, specify	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Paresthesia	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypertriglyceridemia	7.7% 3/39 • Number of events 6 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hyponatremia	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Bone pain	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Lung infection	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Anxiety	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Depression	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Vascular disorders Thromboembolic event	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Eye disorders Blurred vision	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Eye disorders Conjunctivitis	7.7% 3/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Cardiac disorders Sinus tachycardia	7.7% 3/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Investigations Cholesterol high	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Fecal incontinence	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Gastrointestinal disorders Stomach pain	5.1% 2/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders General disorders and administration site conditions - Other, specify	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Malaise	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Non-cardiac chest pain	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
General disorders Pain	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Nervous system disorders Neuralgia	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypercalcemia	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hyperglycemia	5.1% 2/39 • Number of events 6 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Metabolism and nutrition disorders Hypocalcemia	5.1% 2/39 • Number of events 6 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Musculoskeletal and connective tissue disorders Chest wall pain	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Bronchial infection	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Peripheral nerve infection	5.1% 2/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Sepsis	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Skin infection	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Infections and infestations Urinary tract infection	5.1% 2/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Skin and subcutaneous tissue disorders Skin ulceration	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Agitation	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Confusion	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Psychiatric disorders Delirium	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Vascular disorders Hot flashes	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Renal and urinary disorders Acute kidney injury	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Renal and urinary disorders Renal and urinary disorders - Other, specify	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Renal and urinary disorders Urinary incontinence	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Renal and urinary disorders Urinary retention	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Eye disorders Dry eye	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Eye disorders Eye disorders - Other	5.1% 2/39 • Number of events 4 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Cardiac disorders Heart failure	5.1% 2/39 • Number of events 2 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	5.1% 2/39 • Number of events 3 • Adverse events were collected for 3 years and 1 month. Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.

Additional Information

Lymphoma Disease Oriented Team

University of Wisconsin Carbone Cancer Center

Phone: 608-265-5542

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place