Trial Outcomes & Findings for Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma (NCT NCT00715208)
NCT ID: NCT00715208
Last Updated: 2013-04-29
Results Overview
Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
30 weeks
Results posted on
2013-04-29
Participant Flow
Participant milestones
| Measure |
VELCADE R-CAP
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
48
|
|
Overall Study
COMPLETED
|
6
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
VELCADE R-CAP
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
Baseline Characteristics
Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
VELCADE R-CAP
n=7 Participants
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age Continuous
|
62.9 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
48 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 weeksPopulation: Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.
Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.
Outcome measures
| Measure |
VELCADE R-CAP
n=6 Participants
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Number of Patients With Complete Response (CR)
|
1 participants
Interval 0.0 to 36.0
|
13 participants
|
SECONDARY outcome
Timeframe: 30 weeksPopulation: Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.
OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria. CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET.
Outcome measures
| Measure |
VELCADE R-CAP
n=6 Participants
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Number of Participants With Overall Response (OR)
|
6 participants
|
37 participants
|
SECONDARY outcome
Timeframe: Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PDPopulation: Safety population: Treated
PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).
Outcome measures
| Measure |
VELCADE R-CAP
n=7 Participants
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Percentage of Participants With Progression-free Survival (PFS) at 1 Year
|
67 percentage of participants
Interval 9.4 to
|
63 percentage of participants
Interval 11.2 to
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)
Time (in months) from the first documentation of a response (CR or partial response \[PR\]) to the date of first documentation of progressive disease or relapse from complete response. CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria.
Outcome measures
| Measure |
VELCADE R-CAP
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=37 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Duration of Response
|
—
|
21.9 Months
Interval 9.4 to
The upper endpoint is not estimable (NE). For subjects who had not progressed, duration of response was censored at the last response assessment that was stable disease (SD) or better.
|
SECONDARY outcome
Timeframe: From completion of informed consent through 30 days after the last dose of study drugPopulation: Safety Population: Treated patients
Outcome measures
| Measure |
VELCADE R-CAP
n=7 Participants
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 Participants
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Number of Patients Who Experienced at Least One Serious Adverse Event
|
2 participants
|
12 participants
|
Adverse Events
VELCADE R-CAP
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
VELCADE R-CP
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VELCADE R-CAP
n=7 participants at risk
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 participants at risk
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Infections and infestations
Bronchitis NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Bronchitis acute NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Pneumonia NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Neutropenic sepsis
|
14.3%
1/7
|
0.00%
0/48
|
|
Infections and infestations
Oropharyngeal candidiasis
|
14.3%
1/7
|
0.00%
0/48
|
|
Infections and infestations
Respiratory tract infection NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7
|
2.1%
1/48
|
|
Infections and infestations
Viral infection NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
General disorders
Pyrexia
|
14.3%
1/7
|
6.2%
3/48
|
|
General disorders
Fatigue
|
0.00%
0/7
|
2.1%
1/48
|
|
General disorders
Weakness
|
0.00%
0/7
|
2.1%
1/48
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7
|
2.1%
1/48
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/7
|
2.1%
1/48
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7
|
4.2%
2/48
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
14.3%
1/7
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/7
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (excl neonatal)
|
0.00%
0/7
|
2.1%
1/48
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/7
|
2.1%
1/48
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7
|
2.1%
1/48
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7
|
2.1%
1/48
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7
|
2.1%
1/48
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Investigations
Blood culture positive
|
0.00%
0/7
|
4.2%
2/48
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/7
|
2.1%
1/48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
2.1%
1/48
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
0.00%
0/7
|
2.1%
1/48
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
2.1%
1/48
|
|
Nervous system disorders
Headache NOS
|
0.00%
0/7
|
2.1%
1/48
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
2.1%
1/48
|
|
Vascular disorders
Hypertension aggravated
|
0.00%
0/7
|
2.1%
1/48
|
Other adverse events
| Measure |
VELCADE R-CAP
n=7 participants at risk
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
|
VELCADE R-CP
n=48 participants at risk
VELCADE, rituximab, cyclophosphamide, and prednisone
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.3%
1/7
|
0.00%
0/48
|
|
Blood and lymphatic system disorders
Anaemia
|
42.9%
3/7
|
16.7%
8/48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.9%
3/7
|
12.5%
6/48
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
28.6%
2/7
|
4.2%
2/48
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
14.3%
1/7
|
6.2%
3/48
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7
|
2.1%
1/48
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7
|
4.2%
2/48
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7
|
50.0%
24/48
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7
|
43.8%
21/48
|
|
Gastrointestinal disorders
Vomiting NOS
|
0.00%
0/7
|
25.0%
12/48
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7
|
20.8%
10/48
|
|
Gastrointestinal disorders
Stomatitis
|
42.9%
3/7
|
4.2%
2/48
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
0.00%
0/7
|
6.2%
3/48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.1%
4/7
|
16.7%
8/48
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
28.6%
2/7
|
4.2%
2/48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
6.2%
3/48
|
|
Skin and subcutaneous tissue disorders
Skin lesion NOS
|
14.3%
1/7
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
1/7
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.3%
1/7
|
0.00%
0/48
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
14.3%
1/7
|
0.00%
0/48
|
|
General disorders
Rigors
|
57.1%
4/7
|
12.5%
6/48
|
|
General disorders
Oedema lower limb
|
28.6%
2/7
|
10.4%
5/48
|
|
General disorders
Fatigue aggravated
|
14.3%
1/7
|
10.4%
5/48
|
|
General disorders
Infusion associated symptoms
|
0.00%
0/7
|
6.2%
3/48
|
|
General disorders
Fall
|
28.6%
2/7
|
0.00%
0/48
|
|
General disorders
Chest pain
|
0.00%
0/7
|
6.2%
3/48
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
2/7
|
12.5%
6/48
|
|
Metabolism and nutrition disorders
Dehydration
|
42.9%
3/7
|
6.2%
3/48
|
|
Blood and lymphatic system disorders
Lymphopenia
|
28.6%
2/7
|
12.5%
6/48
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
28.6%
2/7
|
20.8%
10/48
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7
|
6.2%
3/48
|
|
Nervous system disorders
Peripheral neuropathy aggravated
|
14.3%
1/7
|
0.00%
0/48
|
|
Nervous system disorders
Dizziness (excl vertigo)
|
28.6%
2/7
|
14.6%
7/48
|
|
Nervous system disorders
Dysgeusia
|
57.1%
4/7
|
2.1%
1/48
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7
|
0.00%
0/48
|
|
Nervous system disorders
Restless leg syndrome
|
14.3%
1/7
|
0.00%
0/48
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
0.00%
0/7
|
16.7%
8/48
|
|
Infections and infestations
Herpes zoster
|
14.3%
1/7
|
6.2%
3/48
|
|
Infections and infestations
Urinary tract infection NOS
|
14.3%
1/7
|
6.2%
3/48
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7
|
2.1%
1/48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7
|
16.7%
8/48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis NOS
|
14.3%
1/7
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7
|
0.00%
0/48
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/7
|
6.2%
3/48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7
|
12.5%
6/48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7
|
10.4%
5/48
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7
|
6.2%
3/48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7
|
4.2%
2/48
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
28.6%
2/7
|
2.1%
1/48
|
|
Musculoskeletal and connective tissue disorders
Peripheral swelling
|
0.00%
0/7
|
6.2%
3/48
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7
|
8.3%
4/48
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7
|
8.3%
4/48
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7
|
8.3%
4/48
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7
|
12.5%
6/48
|
|
Investigations
Blood uric acid increased
|
0.00%
0/7
|
8.3%
4/48
|
|
Investigations
Platelet count decreased
|
0.00%
0/7
|
8.3%
4/48
|
|
Investigations
Blood glucose increased
|
0.00%
0/7
|
6.2%
3/48
|
|
Investigations
Blood urea increased
|
14.3%
1/7
|
2.1%
1/48
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7
|
0.00%
0/48
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7
|
14.6%
7/48
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7
|
0.00%
0/48
|
|
Vascular disorders
Hypotension NOS
|
28.6%
2/7
|
4.2%
2/48
|
|
Vascular disorders
Flushing
|
0.00%
0/7
|
6.2%
3/48
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7
|
8.3%
4/48
|
|
Eye disorders
Eye irritation
|
0.00%
0/7
|
8.3%
4/48
|
|
Cardiac disorders
Tachycardia NOS
|
14.3%
1/7
|
2.1%
1/48
|
|
Cardiac disorders
Sinus Tachycardia
|
14.3%
1/7
|
4.2%
2/48
|
|
Cardiac disorders
Ventricular hypokinesia
|
14.3%
1/7
|
0.00%
0/48
|
|
Renal and urinary disorders
Renal failure acute
|
14.3%
1/7
|
2.1%
1/48
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
1/7
|
2.1%
1/48
|
|
Hepatobiliary disorders
Hypoproteinaemia
|
14.3%
1/7
|
2.1%
1/48
|
|
Immune system disorders
Hypersensitivity NOS
|
14.3%
1/7
|
0.00%
0/48
|
|
Reproductive system and breast disorders
Breast discomfort
|
14.3%
1/7
|
0.00%
0/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place