Trial Outcomes & Findings for Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma (NCT NCT01258998)
NCT ID: NCT01258998
Last Updated: 2020-11-04
Results Overview
Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regression of measurable disease and no new sites, 50% decrease in , sum of the product of the diameters SPD of up to 6 largest dominant masses; no increase in size of other nodes(a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT, 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen, Irrelevant if positive prior to therapy; cell type should be specified.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
4 months
Results posted on
2020-11-04
Participant Flow
Recruitment Period: December 10, 2010 to February 20, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Akt Inhibitor MK2206
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Akt Inhibitor MK2206
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Akt Inhibitor MK2206)
n=60 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Based on intent-to-treat analysis.
Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regression of measurable disease and no new sites, 50% decrease in , sum of the product of the diameters SPD of up to 6 largest dominant masses; no increase in size of other nodes(a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT, 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen, Irrelevant if positive prior to therapy; cell type should be specified.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=59 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Objective Response Rate (ORR)
Complete Response (CR)
|
2 Participants
|
|
Objective Response Rate (ORR)
Partial Response (PR)
|
6 Participants
|
SECONDARY outcome
Timeframe: From treatment start date until the date of first documented progression or date of death from any cause, whichever came first.Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=59 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Progression-free Survival
|
2.8 months
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.Kaplan-Meier method was used. The log-rank test was performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model was used to include multiple covariates in the time-to-event analysis.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=59 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Duration of Response
|
5.8 months
Interval 1.8 to 11.6
|
SECONDARY outcome
Timeframe: From the start of treatment to death or 30 days after removal from the study whichever occurs firstPopulation: PI is not available, therefore, no data is available for reporting in this section due to the overall survival was not an outcome to be measured initially. All efforts were made to retrieve data.
Number of surviving participants without disease progression or death for any reason at one year post treatment. Kaplan-Meier method was used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 30 days post-treatmentThe changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=36 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Number of Participants With Change in Cytokine Levels With p Values <0.05
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 30 days post-treatmentThe changes in the chemokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=36 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Number of Participants With Change in Chemokine Levels With p Values <0.05
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to up to 30 days post-treatmentThe changes in the cytokine levels from baseline analyzed by Wilcoxon signed rank test. P values \< 0.05 were considered statistically significant.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=36 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Number of Participants With Change in Biomarker Levels With p Values <0.05
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 daysToxicity data will be summarized by frequency tables.
Outcome measures
| Measure |
Akt Inhibitor MK2206
n=59 Participants
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Thrombocytopenia
|
15 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neutropenia
|
10 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
12 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anorexia
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Aspartate aminotransferase elevation
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Constipation
|
3 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nausea
|
9 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyperglycemia
|
34 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Elevated creatinine
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Conjunctivitis
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Rash
|
31 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dry skin
|
4 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pruritus
|
6 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anemia
|
5 Participants
|
|
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lymphopenia
|
13 Participants
|
Adverse Events
Treatment (Akt Inhibitor MK2206)
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=60 participants at risk
Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
5.0%
3/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
Other adverse events
| Measure |
Treatment (Akt Inhibitor MK2206)
n=60 participants at risk
Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.3%
2/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Eye disorders
Eye pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Facial nerve disorder
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Facial pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Fatigue
|
6.7%
4/60 • Number of events 24 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Fever
|
1.7%
1/60 • Number of events 14 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.0%
3/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
General disorders and administration site conditions
|
3.3%
2/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 10 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
1.7%
1/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
8.3%
5/60 • Number of events 89 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
3.3%
2/60 • Number of events 14 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypernatremia
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Hypertension
|
6.7%
4/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
5.0%
3/60 • Number of events 16 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
1.7%
1/60 • Number of events 9 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
3.3%
2/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
1.7%
1/60 • Number of events 6 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
1.7%
1/60 • Number of events 16 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
1.7%
1/60 • Number of events 16 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Hypotension
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Infections and infestations
Infections and infestations
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Insomnia
|
1.7%
1/60 • Number of events 6 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Investigations
Investigations
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Lethargy
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
3/60 • Number of events 13 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Lymphedema
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
1.7%
1/60 • Number of events 59 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Malaise
|
1.7%
1/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Mucosal infection
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 15 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
5.0%
3/60 • Number of events 19 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Non-cardiac chest pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Pain
|
3.3%
2/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
1.7%
1/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
1.7%
1/60 • Number of events 29 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Immune system disorders
Allergic rhinitis
|
3.3%
2/60 • Number of events 14 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
18.3%
11/60 • Number of events 71 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Anorexia
|
1.7%
1/60 • Number of events 9 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Anxiety
|
3.3%
2/60 • Number of events 10 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
5.0%
3/60 • Number of events 12 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
2/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
1.7%
1/60 • Number of events 6 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Eye disorders
Blurred vision
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
2/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
1.7%
1/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Chest wall pain
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Chills
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Confusion
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/60 • Number of events 22 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Creatinine increased
|
1.7%
1/60 • Number of events 14 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Dehydration
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Depression
|
5.0%
3/60 • Number of events 8 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
2/60 • Number of events 12 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Eye disorders
Dry eye
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.7%
1/60 • Number of events 7 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
2/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • Number of events 12 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Edema limbs
|
1.7%
1/60 • Number of events 10 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Edema trunk
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Hepatobiliary disorders
Pancreatitis
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Paresthesia
|
5.0%
3/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/60 • Number of events 15 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
5.0%
3/60 • Number of events 47 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
1/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/60 • Number of events 16 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Psychiatric disorders
Psychiatric disorders
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
2/60 • Number of events 59 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Rectal pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Seizure
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus bradycardia
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus tachycardia
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.7%
1/60 • Number of events 4 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60 • Number of events 5 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Nervous system disorders
Tremor
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.3%
2/60 • Number of events 11 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
1/60 • Number of events 2 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 3 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
General disorders
Weight loss
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
5.0%
3/60 • Number of events 29 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
1.7%
1/60 • Number of events 1 • Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study, up to 3 years.
|
Additional Information
Christopher R Flowers,Chair, Lymphoma-Myeloma
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713- 745-6095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60