Trial Outcomes & Findings for Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis (NCT NCT01383759)
NCT ID: NCT01383759
Last Updated: 2020-04-07
Results Overview
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
12 months
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
Amyloidosis
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
1
|
|
Overall Study
COMPLETED
|
19
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis
Baseline characteristics by cohort
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
n=1 Participants
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
63 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data were not collected for MIDD group.
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Percentage of Participants Experiencing Progression Free Survival at 12 Months
|
84 percentage of patients
Interval 69.0 to 99.0
|
—
|
PRIMARY outcome
Timeframe: 2 yearsToxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
n=1 Participants
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Participants Evaluated for Toxicity
|
19 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 years\[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; \<5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved \[iFLC\] and uninvolved FLC) to\<4mg/dl) and Partial Response (PR)\] (\>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
n=1 Participants
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
To Estimate the Hematologic Response Rate
Complete Response (CR)
|
7 Participants
|
0 Participants
|
|
To Estimate the Hematologic Response Rate
Partial Response (PR)
|
4 Participants
|
0 Participants
|
|
To Estimate the Hematologic Response Rate
Progression of Disease (POD)
|
1 Participants
|
0 Participants
|
|
To Estimate the Hematologic Response Rate
Stable Disease (SD)
|
1 Participants
|
0 Participants
|
|
To Estimate the Hematologic Response Rate
Very Good Partial Response (VGPR)
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Organ Response - Cardiac Involvement at 12 Months
Participants without cardiac involvement
|
7 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 12 Months
Cardiac involvement, improved
|
8 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 12 Months
Cardiac involvement, progressed
|
2 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 12 Months
Cardiac involvement, died during induction
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 monthsfollowing the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Progression Free Survival at 24 Months
|
68 percentage of patients
Interval 50.0 to 93.0
|
—
|
SECONDARY outcome
Timeframe: 24 months24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Organ Response - Cardiac Involvement at 24 Months
Participants without cardiac involvement
|
7 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 24 Months
Cardiac involvement, improved
|
8 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 24 Months
Cardiac involvement, progressed
|
2 Participants
|
—
|
|
Organ Response - Cardiac Involvement at 24 Months
Cardiac involvement, died during induction
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=19 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Organ Response - Renal Involvement at 12 Months
No renal involvment
|
7 Participants
|
—
|
|
Organ Response - Renal Involvement at 12 Months
Renal involvment, improved
|
9 Participants
|
—
|
|
Organ Response - Renal Involvement at 12 Months
Renal involvment, profressed
|
2 Participants
|
—
|
|
Organ Response - Renal Involvement at 12 Months
Renal involvment, died
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 1 participants died at the previous 12 month follow up point
24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.
Outcome measures
| Measure |
Amyloidosis
n=18 Participants
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Organ Response - Renal Involvement at 24 Months
No renal involvement
|
7 Participants
|
—
|
|
Organ Response - Renal Involvement at 24 Months
Renal Involvement, improved
|
9 Participants
|
—
|
|
Organ Response - Renal Involvement at 24 Months
Normal Renal Function after Kidney Transplant
|
2 Participants
|
—
|
Adverse Events
Amyloidosis
Serious events: 17 serious events
Other events: 19 other events
Deaths: 7 deaths
Monoclonal Ig DepositionDisease (MIDD)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amyloidosis
n=19 participants at risk
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
n=1 participants at risk
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Syncope
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Hypotension
|
21.1%
4/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Lung infection
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Sudden death NOS
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Creatinine increased
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Depressed level of consciousness
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.3%
1/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
Other adverse events
| Measure |
Amyloidosis
n=19 participants at risk
Participants with newly diagnosed AL amyloidosis
|
Monoclonal Ig DepositionDisease (MIDD)
n=1 participants at risk
Participants with newly diagnosed Monoclonal Ig DepositionDisease (MIDD)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
68.4%
13/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
89.5%
17/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
84.2%
16/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Blood bilirubin increased
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
CPK increased
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
31.6%
6/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Cholesterol high
|
47.4%
9/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
2/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Creatinine increased
|
63.2%
12/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Immune system disorders
Cytokine release syndrome
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
42.1%
8/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Edema limbs
|
26.3%
5/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Eye disorders - Other, specify
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Fatigue
|
52.6%
10/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
General disorders
Fever
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Hemoglobin increased
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
21.1%
4/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
19/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
68.4%
13/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
31.6%
6/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
42.1%
8/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
19/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
89.5%
17/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
78.9%
15/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
68.4%
13/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
52.6%
10/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
78.9%
15/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
31.6%
6/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Vascular disorders
Hypotension
|
26.3%
5/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
INR increased
|
57.9%
11/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Lipase increased
|
10.5%
2/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
General disorders
Localized edema
|
5.3%
1/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
89.5%
17/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
36.8%
7/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Neutrophil count decreased
|
78.9%
15/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
21.1%
4/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Paresthesia
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Eye disorders
Periorbital edema
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
63.2%
12/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Investigations
Platelet count decreased
|
100.0%
19/19 • 1 year
|
100.0%
1/1 • 1 year
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Seizure
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Serum amylase increased
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Syncope
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Tremor
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Renal and urinary disorders
Urinary urgency
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Reproductive system and breast disorders
Vaginal pain
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Nervous system disorders
Vasovagal reaction
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Weight gain
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
Weight loss
|
10.5%
2/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
1/19 • 1 year
|
0.00%
0/1 • 1 year
|
|
Investigations
White blood cell decreased
|
89.5%
17/19 • 1 year
|
100.0%
1/1 • 1 year
|
Additional Information
Dr. Hani Hassoun
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3228
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place