Trial Outcomes & Findings for Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma (NCT NCT00441168)
NCT ID: NCT00441168
Last Updated: 2014-03-21
Results Overview
The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease \[PD\], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
every 28 days during treatment period for up to 6 to 8 cycles
Results posted on
2014-03-21
Participant Flow
Subjects were recruited from 05 December 2006 to 04 July 2007 at 2 sites in Germany, 1 site in Hungary, 3 sites in Lithuania, 3 sites in Poland and 3 sites in Russia
Subjects who qualified were screened. Subjects were considered for eligibility when the investigator would treat the subject with a combination therapy of vincristine, adriamycin and dexamethasone (VAD) standard therapy. One subject was not randomised because the subject was a screening failure.
Participant milestones
| Measure |
VAD Treatment
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Treatment Period
STARTED
|
17
|
13
|
|
Treatment Period
TREATED
|
16
|
13
|
|
Treatment Period
COMPLETED
|
6
|
7
|
|
Treatment Period
NOT COMPLETED
|
11
|
6
|
|
Follow-up Period
STARTED
|
17
|
13
|
|
Follow-up Period
COMPLETED
|
5
|
4
|
|
Follow-up Period
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
VAD Treatment
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Treatment Period
Death
|
3
|
0
|
|
Treatment Period
Adverse Event
|
1
|
2
|
|
Treatment Period
Progressive Disease
|
0
|
2
|
|
Treatment Period
Protocol Violation
|
0
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
3
|
0
|
|
Treatment Period
qualified for stem-cell transplantation
|
3
|
0
|
|
Treatment Period
refractory disease
|
1
|
0
|
|
Follow-up Period
Death
|
3
|
0
|
|
Follow-up Period
Lost to Follow-up
|
5
|
6
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
0
|
|
Follow-up Period
Other
|
1
|
3
|
Baseline Characteristics
Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma
Baseline characteristics by cohort
| Measure |
VAD Treatment
n=16 Participants
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=13 Participants
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Karnofsky Performance Status
≤50
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Karnofsky Performance Status
60
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Karnofsky Performance Status
70
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body Surface Area
|
1.855 m2
STANDARD_DEVIATION 0.233 • n=5 Participants
|
1.924 m2
STANDARD_DEVIATION 0.219 • n=7 Participants
|
1.886 m2
STANDARD_DEVIATION 0.226 • n=5 Participants
|
|
Height
|
168.8 cm
STANDARD_DEVIATION 11.2 • n=5 Participants
|
169.8 cm
STANDARD_DEVIATION 9.5 • n=7 Participants
|
169.3 cm
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Weight
|
75.9 kg
STANDARD_DEVIATION 15.7 • n=5 Participants
|
78.3 kg
STANDARD_DEVIATION 14.5 • n=7 Participants
|
77.0 kg
STANDARD_DEVIATION 15.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: every 28 days during treatment period for up to 6 to 8 cyclesPopulation: Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease \[PD\], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.
Outcome measures
| Measure |
VAD Treatment
n=15 Participants
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=13 Participants
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Best Confirmed Disease Response
Unknown/Unable to Assess
|
4 participants
|
4 participants
|
|
Best Confirmed Disease Response
CR
|
0 participants
|
1 participants
|
|
Best Confirmed Disease Response
PR
|
5 participants
|
6 participants
|
|
Best Confirmed Disease Response
Response Rate (CR + PR)
|
5 participants
|
7 participants
|
|
Best Confirmed Disease Response
MR
|
2 participants
|
0 participants
|
|
Best Confirmed Disease Response
Overall Response (CR + PR + MR)
|
7 participants
|
7 participants
|
|
Best Confirmed Disease Response
NC
|
3 participants
|
1 participants
|
|
Best Confirmed Disease Response
PD
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: every 28 days during treatment period for up to 6 to 8 cyclesPopulation: Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.
Outcome measures
| Measure |
VAD Treatment
n=15 Participants
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=13 Participants
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Best Reported Disease Response
CR
|
1 participants
|
3 participants
|
|
Best Reported Disease Response
PR
|
6 participants
|
4 participants
|
|
Best Reported Disease Response
Response Rate (CR + PR)
|
7 participants
|
7 participants
|
|
Best Reported Disease Response
MR
|
2 participants
|
3 participants
|
|
Best Reported Disease Response
Overall Response (CR + PR + MR)
|
9 participants
|
10 participants
|
|
Best Reported Disease Response
NC
|
5 participants
|
3 participants
|
|
Best Reported Disease Response
PD
|
0 participants
|
0 participants
|
|
Best Reported Disease Response
Unknown/Unable to Assess
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: every 28 days during treatment period for up to 6 to 8 cyclesPopulation: Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).
DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = (\[Date of PD or date of censoring - Date of best response\]+1)/30.44.
Outcome measures
| Measure |
VAD Treatment
n=5 Participants
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=6 Participants
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Duration of Response (DOR)
patient 6
|
NA months
only 5 patients have been analyzed in this arm
|
7.42 months
|
|
Duration of Response (DOR)
patient 1
|
1.68 months
Interval 1.68 to 6.18
|
2.83 months
Interval 2.83 to 7.69
|
|
Duration of Response (DOR)
patient 2
|
6.18 months
|
7.69 months
|
|
Duration of Response (DOR)
patient 3
|
3.71 months
|
5.52 months
|
|
Duration of Response (DOR)
patient 4
|
5.42 months
|
6.57 months
|
|
Duration of Response (DOR)
patient 5
|
4.73 months
|
4.96 months
|
Adverse Events
VAD Treatment
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
PAD Treatment
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAD Treatment
n=16 participants at risk
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=13 participants at risk
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Asthenia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Bronchitis acute
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Nervous system disorders
Cerebrovascular accident
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Death
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Pneumonia
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Septic shock
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Sudden cardiac death
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
Other adverse events
| Measure |
VAD Treatment
n=16 participants at risk
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
PAD Treatment
n=13 participants at risk
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Nervous system disorders
Ageusia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Asthenia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 3 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Bronchitis acute
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 4 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Cystitis
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Extravasation
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Eye disorders
Eye irritation
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Face oedema
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 4 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
15.4%
2/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Herpes simplex
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
15.4%
2/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
30.8%
4/13 • Number of events 5 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
2/16 • Number of events 3 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
4/16 • Number of events 11 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
15.4%
2/13 • Number of events 7 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
4/16 • Number of events 9 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 3 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Oedema peripheral
|
6.2%
1/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 3 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
15.4%
2/13 • Number of events 4 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
General disorders
Pyrexia
|
0.00%
0/16 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Respiratory tract infection
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
7.7%
1/13 • Number of events 4 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Vascular disorders
Thrombophlebitis
|
6.2%
1/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Vascular disorders
Venous thrombosis limb
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
2/16 • Number of events 2 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Infections and infestations
Viral infection
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Eye disorders
Visual acuity reduced
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
|
Investigations
White blood cell count increased
|
6.2%
1/16 • Number of events 1 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
0.00%
0/13 • For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
|
Additional Information
EMEA Medical Affairs Director Oncology
Jan-Cilag Germany
Phone: +49 2137 955-492
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60