Trial Outcomes & Findings for Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias (NCT NCT00410423)
NCT ID: NCT00410423
Last Updated: 2025-04-30
Results Overview
Dose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
30-90 days
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Phase 1 - Bortezomib 0.7mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.0 mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.3 mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 2 - Bortezomib 1.3mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|---|---|---|
|
Phase 1 - Dose Level 1
STARTED
|
3
|
0
|
0
|
0
|
|
Phase 1 - Dose Level 1
COMPLETED
|
3
|
0
|
0
|
0
|
|
Phase 1 - Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 1 - Dose Level 2
STARTED
|
0
|
5
|
0
|
0
|
|
Phase 1 - Dose Level 2
COMPLETED
|
0
|
5
|
0
|
0
|
|
Phase 1 - Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 1 - Dose Level 3
STARTED
|
0
|
0
|
3
|
0
|
|
Phase 1 - Dose Level 3
COMPLETED
|
0
|
0
|
3
|
0
|
|
Phase 1 - Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
44
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
44
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias
Baseline characteristics by cohort
| Measure |
Bortezomib
n=55 Participants
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
51.39 years
STANDARD_DEVIATION 15.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-90 daysDose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.
Outcome measures
| Measure |
Phase 1 - Bortezomib 0.7mg/m^2
n=3 Participants
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.0 mg/m^2
n=5 Participants
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.3mg/m^2
n=3 Participants
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity in Phase I
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. The percentage of participants that experienced complete response will be reported.
Outcome measures
| Measure |
Phase 1 - Bortezomib 0.7mg/m^2
n=44 Participants
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.0 mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
Phase 1 - Bortezomib 1.3mg/m^2
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|---|---|
|
Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II
|
27 percentage of participants
|
—
|
—
|
Adverse Events
Bortezomib
Serious events: 10 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib
n=38 participants at risk
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|
|
General disorders
Cough
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.7%
9/38 • Number of events 9
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Infections and infestations
Infection
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
Other adverse events
| Measure |
Bortezomib
n=38 participants at risk
Bortezomib in combination with mitoxantrone, etoposide and cytarabine
Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
|
|---|---|
|
General disorders
Abdominal pain
|
26.3%
10/38 • Number of events 11
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Achiness
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Acute infusion reaction
|
18.4%
7/38 • Number of events 13
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Allergic reaction
|
7.9%
3/38 • Number of events 7
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Alopecia
|
15.8%
6/38 • Number of events 6
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Anorexia
|
42.1%
16/38 • Number of events 19
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Psychiatric disorders
Anxiety
|
21.1%
8/38 • Number of events 8
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Arm pain
|
7.9%
3/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Nervous system disorders
Ataxia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Back pain
|
18.4%
7/38 • Number of events 8
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Bladder stone
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Bleeding
|
7.9%
3/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Bloating
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Blood-tinged mucus
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Bone pain
|
7.9%
3/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Breast mass
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Bruising
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Bump on finger
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Calf pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Eye disorders
Change in vision
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Chest pain
|
15.8%
6/38 • Number of events 7
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Chills
|
26.3%
10/38 • Number of events 11
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Chronic rhinsinusitis
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Infections and infestations
Clostridium difficile
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Congestive heart failure
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Constipation
|
36.8%
14/38 • Number of events 17
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Cough
|
23.7%
9/38 • Number of events 10
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Decreased appetite
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dehydration
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Psychiatric disorders
Depression
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
19/38 • Number of events 19
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Distended abdomen
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dizziness
|
23.7%
9/38 • Number of events 9
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dry cough
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Eye disorders
Dry eyes
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dry mouth
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dry, cracked lips
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dysgeusia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Dysphagia
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.9%
11/38 • Number of events 12
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Dysuria
|
2.6%
1/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Edema
|
47.4%
18/38 • Number of events 21
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Elbow pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Epigastric discomfort
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Epistaxis
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Facial swelling
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Fatigue
|
47.4%
18/38 • Number of events 19
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.6%
12/38 • Number of events 14
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Fever
|
23.7%
9/38 • Number of events 12
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Fistula
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Flank pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Fluid retention
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Foot pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Gas pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Genitourinary obstruction
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Gum swelling
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Hand pain
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Headache
|
44.7%
17/38 • Number of events 19
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Heartburn
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hematuria
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.5%
4/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Hives
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Hoarseness
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Hot flashes
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hypertension
|
15.8%
6/38 • Number of events 6
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hyperuricemia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hypokalemia
|
13.2%
5/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hyponatremia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Hypotension
|
42.1%
16/38 • Number of events 18
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Incontinence of stool
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Increased alklaline phosphatase
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Increased ALT
|
7.9%
3/38 • Number of events 6
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Increased AST
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Increased creatinine
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Infections and infestations
Infection
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Insomnia
|
13.2%
5/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Iron overload
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.2%
5/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Eye disorders
Itchy eyes
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Joint pain
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Knee pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Leg pain
|
10.5%
4/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Lesion
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Hepatobiliary disorders
Liver dysfunction
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Gastrointestinal disorders
Mucositis
|
42.1%
16/38 • Number of events 17
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Muscle cramping
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Muscle pain
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Nausea
|
71.1%
27/38 • Number of events 32
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Neck pain
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Nervous system disorders
Neuropathy
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.5%
4/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Night sweats
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Oral pain
|
10.5%
4/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Oral thrush
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Pain at femoral line site
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Pain at PICC site
|
13.2%
5/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Pain from bone marrow biopsy
|
15.8%
6/38 • Number of events 6
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Pain from mouth sore
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Palpitations
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.5%
15/38 • Number of events 16
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Rhinitis
|
5.3%
2/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Rib pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Infections and infestations
Sepsis
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Shoulder pain
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Sinus bradycardia
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sinus congestion
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sinus headache
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sinus pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Sinus tachycardia
|
18.4%
7/38 • Number of events 7
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sinusitis
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sore in mouth
|
5.3%
2/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sore throat
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sternal pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Stomach pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Strong urine odor
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Sweating
|
10.5%
4/38 • Number of events 4
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Swelling of parotid gland
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Cardiac disorders
Tachycardia
|
21.1%
8/38 • Number of events 8
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Thigh pain
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Nervous system disorders
Tingling in fingertips
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Nervous system disorders
Tingling in palms
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Toe pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Tongue pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Tooth pain
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Tremors
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Trouble sleeping
|
5.3%
2/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Urinary frequency
|
13.2%
5/38 • Number of events 5
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Urinary retention
|
7.9%
3/38 • Number of events 3
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Renal and urinary disorders
Urinary tract infection
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Weakness
|
34.2%
13/38 • Number of events 13
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Weight gain
|
2.6%
1/38 • Number of events 2
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Weight loss
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Wheezing
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
General disorders
Lethargy
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Nervous system disorders
Tingling in toes
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • Number of events 1
Adverse events not available for 17 patients--these patients are excluded from adverse event counts
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place