Trial Outcomes & Findings for Bortezomib in Treating Patients With Lymphoproliferative Disorders (NCT NCT00023764)
NCT ID: NCT00023764
Last Updated: 2015-12-08
Results Overview
The response probability will be estimated. The 95% confidence interval will be provided.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-12-08
Participant Flow
Protocol Open to Accrual 06/21/2001 Protocol Closed to Accrual 03/11/2008 Primary Completion Date 03/10/2009 Recruitment Location is the medical clinic
Participant milestones
| Measure |
PS-341 (Bortezomib)
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
PS-341 (Bortezomib)
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|
|
Overall Study
Other
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression of disease
|
6
|
|
Overall Study
patient received other treatment
|
1
|
|
Overall Study
delay in obtaining staging images
|
1
|
Baseline Characteristics
Bortezomib in Treating Patients With Lymphoproliferative Disorders
Baseline characteristics by cohort
| Measure |
PS-341 (Bortezomib)
n=103 Participants
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsThe response probability will be estimated. The 95% confidence interval will be provided.
Outcome measures
| Measure |
PS-341 (Bortezomib)-Relapsed Patients
n=23 Participants
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
PS-341 (Bortezomib)-Refractory Patients
n=14 Participants
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|---|
|
Response Rate
|
11 participants
|
6 participants
|
Adverse Events
PS-341 (Bortezomib)
Serious events: 20 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PS-341 (Bortezomib)
n=103 participants at risk
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
3/103 • Number of events 3
|
|
Cardiac disorders
Arrhythmia
|
0.97%
1/103 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
1.9%
2/103 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.97%
1/103 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.9%
3/103 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/103 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
5/103 • Number of events 5
|
|
General disorders
Fatigue
|
1.9%
2/103 • Number of events 2
|
|
General disorders
Fever
|
1.9%
2/103 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.97%
1/103 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.97%
1/103 • Number of events 1
|
|
Infections and infestations
Infection, NOS
|
3.9%
4/103 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.97%
1/103 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/103 • Number of events 2
|
|
Nervous system disorders
Neurological disorder
|
0.97%
1/103 • Number of events 1
|
|
General disorders
Pain
|
0.97%
1/103 • Number of events 1
|
|
Nervous system disorders
peripheral motor neuropathy
|
0.97%
1/103 • Number of events 1
|
|
Investigations
Platelet count decrease
|
1.9%
2/103 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
1/103 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.97%
1/103 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.97%
1/103 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.97%
1/103 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.97%
1/103 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.9%
2/103 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.97%
1/103 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.97%
1/103 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • Number of events 1
|
|
Investigations
Weight loss
|
0.97%
1/103 • Number of events 1
|
Other adverse events
| Measure |
PS-341 (Bortezomib)
n=103 participants at risk
Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
7/103 • Number of events 7
|
|
Investigations
Alkaline Phosphatase
|
24.3%
25/103 • Number of events 25
|
|
Metabolism and nutrition disorders
Anorexia
|
7.8%
8/103 • Number of events 8
|
|
Investigations
Bilirubin
|
24.3%
25/103 • Number of events 25
|
|
Gastrointestinal disorders
Constipation
|
21.4%
22/103 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
7/103 • Number of events 7
|
|
Investigations
Creatinine
|
23.3%
24/103 • Number of events 24
|
|
Gastrointestinal disorders
Diarrhea
|
29.1%
30/103 • Number of events 30
|
|
Nervous system disorders
Dizziness
|
9.7%
10/103 • Number of events 10
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
6/103 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.8%
8/103 • Number of events 8
|
|
General disorders
Edema
|
4.9%
5/103 • Number of events 5
|
|
General disorders
Fatigue
|
32.0%
33/103 • Number of events 33
|
|
General disorders
Fever
|
5.8%
6/103 • Number of events 6
|
|
Nervous system disorders
Headache
|
6.8%
7/103 • Number of events 7
|
|
Blood and lymphatic system disorders
Anemia (Hemoglobin decrease)
|
69.9%
72/103 • Number of events 72
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.9%
73/103 • Number of events 73
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.5%
17/103 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypernatremia
|
18.4%
19/103 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.9%
38/103 • Number of events 38
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
35.9%
37/103 • Number of events 37
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.7%
11/103 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.6%
13/103 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.8%
7/103 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.2%
27/103 • Number of events 27
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
11/103 • Number of events 11
|
|
Psychiatric disorders
Insomnia
|
4.9%
5/103 • Number of events 5
|
|
Investigations
White blood cell decrease
|
49.5%
51/103 • Number of events 51
|
|
Investigations
Lymphocyte count decreased
|
39.8%
41/103 • Number of events 41
|
|
Gastrointestinal disorders
Nausea
|
24.3%
25/103 • Number of events 25
|
|
Nervous system disorders
Neuropathy-peripheral
|
13.6%
14/103 • Number of events 14
|
|
Nervous system disorders
Neuropathy-sensory
|
37.9%
39/103 • Number of events 39
|
|
Investigations
Neutrophil count decreased
|
41.7%
43/103 • Number of events 43
|
|
Investigations
PT
|
10.7%
11/103 • Number of events 11
|
|
Investigations
PTT
|
9.7%
10/103 • Number of events 10
|
|
General disorders
Pain, other
|
6.8%
7/103 • Number of events 7
|
|
Investigations
Platelet count decrease
|
81.6%
84/103 • Number of events 84
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
11/103 • Number of events 11
|
|
General disorders
Rigors, chills
|
5.8%
6/103 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increase
|
33.0%
34/103 • Number of events 34
|
|
Investigations
Alanine aminotransferase increase
|
27.2%
28/103 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
4.9%
5/103 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
11.7%
12/103 • Number of events 12
|
|
Investigations
Weight loss
|
4.9%
5/103 • Number of events 5
|
Additional Information
Dr. John Gerecitano
Memorial Sloan-Kettering Cancer Center
Phone: 212-639-3748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60