Trial Outcomes & Findings for Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT00742625)
NCT ID: NCT00742625
Last Updated: 2014-09-12
Results Overview
Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML) A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction. A CR is defined as those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils \> 1000 mL and platelets \>= 100,000 mL). A CRp is defined as a CR except platelets \< 100,000 mL without need for transfusion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
95 participants
Primary outcome timeframe
2 months
Results posted on
2014-09-12
Participant Flow
Between September 2008 and February 2010, 98 participants were recruited at 15 CALGB member institutions and their affiliated hospitals.
Three (3) participants did not begin treatment and were excluded from all analyses per study design
Participant milestones
| Measure |
Bortezomib + Daunorubicin + Cytarabine
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
|---|---|
|
Remission Induction
STARTED
|
95
|
|
Remission Induction
COMPLETED
|
41
|
|
Remission Induction
NOT COMPLETED
|
54
|
|
Consolidation
STARTED
|
41
|
|
Consolidation
COMPLETED
|
20
|
|
Consolidation
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Bortezomib + Daunorubicin + Cytarabine
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
|---|---|
|
Remission Induction
Progression
|
6
|
|
Remission Induction
Failed induction
|
8
|
|
Remission Induction
Adverse Event
|
3
|
|
Remission Induction
Death
|
10
|
|
Remission Induction
Refusal
|
5
|
|
Remission Induction
Non protocol treatment
|
17
|
|
Remission Induction
Other, not specified
|
5
|
|
Consolidation
Progression
|
5
|
|
Consolidation
Adverse Event
|
1
|
|
Consolidation
Death
|
1
|
|
Consolidation
Refused
|
1
|
|
Consolidation
Non protocol therapy
|
13
|
Baseline Characteristics
Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 Participants
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=5 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
31 participants
n=5 Participants
|
|
ECOG Performance Status
1 - Ambulatory, restricted strenuous activity
|
55 participants
n=5 Participants
|
|
ECOG Performance Status
2 - Ambulatory, unable to perform work activities
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsResponse was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML) A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction. A CR is defined as those with \> 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, \<5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils \> 1000 mL and platelets \>= 100,000 mL). A CRp is defined as a CR except platelets \< 100,000 mL without need for transfusion.
Outcome measures
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 Participants
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
Bortezomib (1.0 mg/m^2) + Int-DAC
Bortezomib (1.0 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
Bortezomib (1.3 mg/m^2) + Int-DAC
Bortezomib (1.3 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
|---|---|---|---|
|
Remission Induction Response
Complete response
|
62 participants
|
—
|
—
|
|
Remission Induction Response
Complete response with incomplete platelet recover
|
4 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: during consolidation cycle 1 (42 days)Population: Participants who were registered to bortezomib consolidation were included in the analysis.
DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs. Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death.
Outcome measures
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=3 Participants
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
Bortezomib (1.0 mg/m^2) + Int-DAC
n=3 Participants
Bortezomib (1.0 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
Bortezomib (1.3 mg/m^2) + Int-DAC
n=17 Participants
Bortezomib (1.3 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
|---|---|---|---|
|
Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 10 years)Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 Participants
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
Bortezomib (1.0 mg/m^2) + Int-DAC
Bortezomib (1.0 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
Bortezomib (1.3 mg/m^2) + Int-DAC
Bortezomib (1.3 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
|---|---|---|---|
|
Disease-free Survival
|
8 months
Interval 6.0 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration of study (up to 10 years)Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 Participants
Bortezomib:
Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)
Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11
Cytarabine:
Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5
Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
Bortezomib (1.0 mg/m^2) + Int-DAC
Bortezomib (1.0 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
Bortezomib (1.3 mg/m^2) + Int-DAC
Bortezomib (1.3 mg/m\^2) + Intermediate Dose Cytarabine (Int-DAC)
|
|---|---|---|---|
|
Overall Survival
|
12 months
Interval 8.0 to 19.0
|
—
|
—
|
Adverse Events
Bortezomib + Daunorubicin + Cytarabine
Serious events: 43 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 participants at risk
Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
|---|---|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
25.3%
24/95 • Number of events 27
|
|
Blood and lymphatic system disorders
Hemoglobin
|
45.3%
43/95 • Number of events 51
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify __)
|
13.7%
13/95 • Number of events 15
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
6.3%
6/95 • Number of events 6
|
|
Cardiac disorders
Cardiopulmonary arrest cause unknown (non-fatal)
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
16.8%
16/95 • Number of events 18
|
|
Cardiac disorders
Palpitations
|
2.1%
2/95 • Number of events 2
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
8.4%
8/95 • Number of events 15
|
|
Endocrine disorders
Endocrine - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis)
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.5%
9/95 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
37.9%
36/95 • Number of events 40
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
4.2%
4/95 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.3%
5/95 • Number of events 5
|
|
Gastrointestinal disorders
Enteritis (inflammation of the small bowel)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
1.1%
1/95 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
6.3%
6/95 • Number of events 6
|
|
Gastrointestinal disorders
Ileus GI (functional obstruction of bowel i.e. neuroconstipation)
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
4.2%
4/95 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
31.6%
30/95 • Number of events 32
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Ulcer GI
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
17/95 • Number of events 19
|
|
General disorders
Constitutional Symptoms - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term
|
2.1%
2/95 • Number of events 2
|
|
General disorders
Edema: limb
|
8.4%
8/95 • Number of events 8
|
|
General disorders
Edema: trunk/genital
|
3.2%
3/95 • Number of events 3
|
|
General disorders
Edema:head and neck
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
16.8%
16/95 • Number of events 17
|
|
General disorders
Fever
|
1.1%
1/95 • Number of events 1
|
|
General disorders
Rigors/chills
|
5.3%
5/95 • Number of events 5
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
1.1%
1/95 • Number of events 1
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.1%
2/95 • Number of events 2
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
2.1%
2/95 • Number of events 2
|
|
Infections and infestations
Infection
|
30.5%
29/95 • Number of events 56
|
|
Infections and infestations
Infection - Other (Specify __)
|
8.4%
8/95 • Number of events 8
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
10.5%
10/95 • Number of events 12
|
|
Infections and infestations
Infection with unknown ANC
|
5.3%
5/95 • Number of events 5
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
2.1%
2/95 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
1.1%
1/95 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/95 • Number of events 1
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
27.4%
26/95 • Number of events 29
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
30.5%
29/95 • Number of events 32
|
|
Investigations
Alkaline phosphatase
|
10.5%
10/95 • Number of events 10
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
26.3%
25/95 • Number of events 28
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
5.3%
5/95 • Number of events 5
|
|
Investigations
Cardiac troponin I (cTnI)
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Creatinine
|
8.4%
8/95 • Number of events 8
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
2.1%
2/95 • Number of events 3
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
3.2%
3/95 • Number of events 3
|
|
Investigations
Leukocytes (total WBC)
|
21.1%
20/95 • Number of events 24
|
|
Investigations
Lymphopenia
|
16.8%
16/95 • Number of events 20
|
|
Investigations
Metabolic/Laboratory - Other (Specify __)
|
2.1%
2/95 • Number of events 2
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
45.3%
43/95 • Number of events 50
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
4.2%
4/95 • Number of events 4
|
|
Investigations
Platelets
|
45.3%
43/95 • Number of events 51
|
|
Investigations
Prolonged QTc interval
|
6.3%
6/95 • Number of events 6
|
|
Investigations
Weight gain
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Weight loss
|
3.2%
3/95 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
3.2%
3/95 • Number of events 3
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
20.0%
19/95 • Number of events 20
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
4.2%
4/95 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
10/95 • Number of events 10
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
12.6%
12/95 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
4/95 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
13.7%
13/95 • Number of events 13
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
1.1%
1/95 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium serum-high (hypermagnesemia)
|
4.2%
4/95 • Number of events 4
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
4.2%
4/95 • Number of events 4
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
14.7%
14/95 • Number of events 14
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
5.3%
5/95 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
20.0%
19/95 • Number of events 21
|
|
Metabolism and nutrition disorders
Sodium serum-high (hypernatremia)
|
2.1%
2/95 • Number of events 2
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
6.3%
6/95 • Number of events 6
|
|
Metabolism and nutrition disorders
Uric acid serum-high (hyperuricemia)
|
5.3%
5/95 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
8.4%
8/95 • Number of events 11
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.1%
2/95 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
6.3%
6/95 • Number of events 7
|
|
Nervous system disorders
Hemorrhage CNS
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Neuropathy: cranial
|
1.1%
1/95 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
3.2%
3/95 • Number of events 3
|
|
Nervous system disorders
Neuropathy: sensory
|
16.8%
16/95 • Number of events 21
|
|
Nervous system disorders
Pain
|
12.6%
12/95 • Number of events 30
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
7.4%
7/95 • Number of events 7
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
3.2%
3/95 • Number of events 3
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Vasovagal episode
|
1.1%
1/95 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
5.3%
5/95 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
5.3%
5/95 • Number of events 5
|
|
Psychiatric disorders
Mood alteration
|
6.3%
6/95 • Number of events 7
|
|
Psychiatric disorders
Personality/behavioral
|
1.1%
1/95 • Number of events 1
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.1%
2/95 • Number of events 2
|
|
Renal and urinary disorders
Glomerular filtration rate
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage GU
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
5.3%
5/95 • Number of events 5
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify __)
|
3.2%
3/95 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
7.4%
7/95 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
4/95 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
19/95 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Edema larynx
|
2.1%
2/95 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
4.2%
4/95 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.8%
16/95 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.3%
5/95 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify __)
|
4.2%
4/95 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify __)
|
2.1%
2/95 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
1.1%
1/95 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
2.1%
2/95 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.2%
22/95 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
1.1%
1/95 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.1%
2/95 • Number of events 2
|
|
Vascular disorders
Acute vascular leak syndrome
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Hematoma
|
2.1%
2/95 • Number of events 2
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Hypertension
|
6.3%
6/95 • Number of events 6
|
|
Vascular disorders
Hypotension
|
27.4%
26/95 • Number of events 27
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Visceral arterial ischemia (non-myocardial)
|
1.1%
1/95 • Number of events 1
|
Other adverse events
| Measure |
Bortezomib + Daunorubicin + Cytarabine
n=95 participants at risk
Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
|
|---|---|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
1.1%
1/95 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
52.6%
50/95 • Number of events 67
|
|
Blood and lymphatic system disorders
Hemoglobin
|
80.0%
76/95 • Number of events 146
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify __)
|
3.2%
3/95 • Number of events 3
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify __)
|
6.3%
6/95 • Number of events 7
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
12.6%
12/95 • Number of events 14
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
1.1%
1/95 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
11.6%
11/95 • Number of events 12
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Ocular surface disease
|
1.1%
1/95 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other (Specify __)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.5%
10/95 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhea
|
66.3%
63/95 • Number of events 86
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
3.2%
3/95 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.2%
3/95 • Number of events 3
|
|
Gastrointestinal disorders
Fistula, GI
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify __)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
4.2%
4/95 • Number of events 5
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
12.6%
12/95 • Number of events 15
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
64.2%
61/95 • Number of events 95
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
2.1%
2/95 • Number of events 2
|
|
Gastrointestinal disorders
Ulcer GI
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Ulcer, GI
|
1.1%
1/95 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
38/95 • Number of events 49
|
|
General disorders
Edema: limb
|
15.8%
15/95 • Number of events 18
|
|
General disorders
Edema: trunk/genital
|
2.1%
2/95 • Number of events 3
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
27.4%
26/95 • Number of events 36
|
|
General disorders
Fever
|
3.2%
3/95 • Number of events 5
|
|
General disorders
Pain - Other (Specify, __)
|
3.2%
3/95 • Number of events 3
|
|
General disorders
Rigors/chills
|
16.8%
16/95 • Number of events 19
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.1%
2/95 • Number of events 2
|
|
Immune system disorders
Allergy/Immunology - Other (Specify __)
|
2.1%
2/95 • Number of events 3
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
1.1%
1/95 • Number of events 1
|
|
Infections and infestations
Infection
|
48.4%
46/95 • Number of events 73
|
|
Infections and infestations
Infection - Other (Specify __)
|
6.3%
6/95 • Number of events 7
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
6.3%
6/95 • Number of events 7
|
|
Infections and infestations
Infection with unknown ANC
|
3.2%
3/95 • Number of events 3
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
2.1%
2/95 • Number of events 2
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
42.1%
40/95 • Number of events 65
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
51.6%
49/95 • Number of events 73
|
|
Investigations
Alkaline phosphatase
|
16.8%
16/95 • Number of events 19
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
35.8%
34/95 • Number of events 43
|
|
Investigations
Carbon monoxide diffusion capacity (DL(co))
|
10.5%
10/95 • Number of events 10
|
|
Investigations
Creatinine
|
5.3%
5/95 • Number of events 7
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
2.1%
2/95 • Number of events 4
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
4.2%
4/95 • Number of events 4
|
|
Investigations
Leukocytes (total WBC)
|
24.2%
23/95 • Number of events 39
|
|
Investigations
Lymphopenia
|
17.9%
17/95 • Number of events 28
|
|
Investigations
Metabolic/Laboratory - Other (Specify __)
|
2.1%
2/95 • Number of events 2
|
|
Investigations
Neuroendocrine: ADH secretion abnormality (e.g. SIADH or low ADH)
|
1.1%
1/95 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
80.0%
76/95 • Number of events 142
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
8.4%
8/95 • Number of events 10
|
|
Investigations
Platelets
|
78.9%
75/95 • Number of events 144
|
|
Investigations
Prolonged QTc interval
|
2.1%
2/95 • Number of events 2
|
|
Investigations
Weight loss
|
2.1%
2/95 • Number of events 3
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
25.3%
24/95 • Number of events 30
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
2.1%
2/95 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
23.2%
22/95 • Number of events 26
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
1.1%
1/95 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
2.1%
2/95 • Number of events 3
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
27.4%
26/95 • Number of events 32
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/95 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
24.2%
23/95 • Number of events 39
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
2.1%
2/95 • Number of events 2
|
|
Metabolism and nutrition disorders
Magnesium serum-high (hypermagnesemia)
|
1.1%
1/95 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
5.3%
5/95 • Number of events 7
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
22.1%
21/95 • Number of events 29
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
5.3%
5/95 • Number of events 5
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
28.4%
27/95 • Number of events 36
|
|
Metabolism and nutrition disorders
Sodium serum-high (hypernatremia)
|
2.1%
2/95 • Number of events 2
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
22.1%
21/95 • Number of events 29
|
|
Metabolism and nutrition disorders
Uric acid serum-high (hyperuricemia)
|
4.2%
4/95 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
1.1%
1/95 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
7.4%
7/95 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.6%
12/95 • Number of events 12
|
|
Nervous system disorders
Hemorrhage CNS
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Mental status
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Neurology - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
3.2%
3/95 • Number of events 3
|
|
Nervous system disorders
Neuropathy: sensory
|
22.1%
21/95 • Number of events 36
|
|
Nervous system disorders
Pain
|
27.4%
26/95 • Number of events 70
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
4.2%
4/95 • Number of events 5
|
|
Nervous system disorders
Tremor
|
1.1%
1/95 • Number of events 1
|
|
Nervous system disorders
Vasovagal episode
|
1.1%
1/95 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
3.2%
3/95 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
9.5%
9/95 • Number of events 12
|
|
Psychiatric disorders
Mood alteration
|
11.6%
11/95 • Number of events 16
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
2.1%
2/95 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage GU
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Obstruction, GU
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/95 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
7/95 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
14.7%
14/95 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
9.5%
9/95 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups singultus)
|
1.1%
1/95 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.4%
8/95 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
2.1%
2/95 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.3%
5/95 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.1%
2/95 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify __)
|
4.2%
4/95 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify __)
|
4.2%
4/95 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.1%
2/95 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
3.2%
3/95 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
5.3%
5/95 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.4%
8/95 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
55.8%
53/95 • Number of events 68
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
1.1%
1/95 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
1.1%
1/95 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
6.3%
6/95 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives welts wheals)
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Hematoma
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Hypertension
|
16.8%
16/95 • Number of events 19
|
|
Vascular disorders
Hypotension
|
29.5%
28/95 • Number of events 40
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.1%
1/95 • Number of events 1
|
|
Vascular disorders
Vascular - Other (Specify __)
|
1.1%
1/95 • Number of events 1
|
Additional Information
Eyal Attar, MD
Massachusetts General Hospital Cancer Center
Phone: 617-724-1124
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60