Trial Outcomes & Findings for Velcade Consolidation Bone Study (NCT NCT01286077)
NCT ID: NCT01286077
Last Updated: 2016-05-30
Results Overview
Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit
COMPLETED
PHASE2
106 participants
at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier
2016-05-30
Participant Flow
Participant milestones
| Measure |
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
no treatment, observation only
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
53
|
|
Overall Study
COMPLETED
|
41
|
46
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
no treatment, observation only
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Intercurrent illness
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
The subject starts with alternative MMY
|
0
|
3
|
|
Overall Study
Patient's decision to stop treatment
|
3
|
0
|
|
Overall Study
Progression of disease
|
0
|
1
|
|
Overall Study
refill medication not received in time
|
1
|
0
|
Baseline Characteristics
Velcade Consolidation Bone Study
Baseline characteristics by cohort
| Measure |
Bortezomib
n=51 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=53 Participants
no treatment, observation only
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
n=5 Participants
|
54.7 years
n=7 Participants
|
55.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlierPopulation: ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter
Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit
Outcome measures
| Measure |
Bortezomib
n=38 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=39 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)
|
0.0214 g/mm2
Standard Deviation 0.0306
|
0.0167 g/mm2
Standard Deviation 0.0301
|
PRIMARY outcome
Timeframe: at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlierPopulation: ITT analysis:8 patients in the bortezomib group and 8 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter
Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit
Outcome measures
| Measure |
Bortezomib
n=43 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=45 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment
Femur neck
|
0.0053 g/mm2
Standard Deviation 0.0221
|
0.0044 g/mm2
Standard Deviation 0.0299
|
|
Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment
Femur total
|
0.0071 g/mm2
Standard Deviation 0.0151
|
0.0138 g/mm2
Standard Deviation 0.0288
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.
The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Progression Free Survival
|
39.56 Months
Standard Error 2.02
|
31.66 Months
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS was used for analysis. "N" (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method.
Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)
ICTP (n= 44, 42)
|
-4.11 Microgram per liter
Standard Deviation 4.36
|
-3.51 Microgram per liter
Standard Deviation 3.81
|
|
Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)
Osteocalcin (44, 42)
|
20.15 Microgram per liter
Standard Deviation 28.79
|
14.59 Microgram per liter
Standard Deviation 5.57
|
|
Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)
BAP (42, 40)
|
-0.48 Microgram per liter
Standard Deviation 6.08
|
-2.11 Microgram per liter
Standard Deviation 4.80
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS was used for analysis. "N" (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method.
Change from Baseline in Biochemical Bone Markers: CTX-I was assessed
Outcome measures
| Measure |
Bortezomib
n=42 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=40 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)
|
-66.50 Nanogram per liter
Standard Deviation 258.26
|
-77.68 Nanogram per liter
Standard Deviation 158.23
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS was used for analysis. "N" (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method.
Bone markers Dickkopf homolog 1 (DKK-1) was measured on serum samples.
Outcome measures
| Measure |
Bortezomib
n=43 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=40 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)
|
-39.31 Picomole per liter
Standard Deviation 82.87
|
-25.15 Picomole per liter
Standard Deviation 87.20
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period
Outcome measures
| Measure |
Bortezomib
n=42 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=40 Participants
no treatment, observation only
|
|---|---|---|
|
Number of Patients With Skeletal Events
|
0 patients
|
0 patients
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: Data could not be summarised statistically due to insufficient data at End of treatment.
Appearance of new bone lesions assessed by skeletal survey compared to baseline
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Appearance of New Bone Lesions Compared to Baseline
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.
T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.
Outcome measures
| Measure |
Bortezomib
n=13 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=21 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Spine T-score
|
1.2028 T score
Standard Deviation 0.2004
|
1.1811 T score
Standard Deviation 0.1689
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method.
The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Karnofsky Performance Status
Screening
|
92.4 Units on a scale
Standard Deviation 9.2
|
91.7 Units on a scale
Standard Deviation 7.0
|
|
Karnofsky Performance Status
Follow-up
|
0.0 Units on a scale
Standard Deviation 11.4
|
0.4 Units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Overall Survival
|
49.90 Months
Standard Error 1.48
|
47.26 Months
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.
Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter \[mm\]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)
|
-0.3 millimeter (mm)
Standard Deviation 18.4
|
2.9 millimeter (mm)
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Tumor response was assessed as VGPR based on IMWG response criteria if, a) serum/urine M protein detectable by immunofixation but not on electrophoresis or; b) greater than or equal to 90% reduction in serum M protein plus urine M protein level less than 100 milligram/24 hour. CR=normal free light chain (FLC) ratio and absence of phenotypically aberrant plasma cells (PC) in bone marrow with a minimum of 3000 total PC analyzed by multiparametric flow cytometry; Complete response (CR) negative immunofixation on the serum and urine and, disappearance of any soft tissue plasmocytomas and \<5% plasma cells in bone marrow.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria
|
82.6 Percentage of participants
1.48
|
72.3 Percentage of participants
1.26
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of \>=25% from lowest response level in any one or more of the following: serum M protein (absolute increase \>=0.5 g/dl)c or urine M protein (absolute increase \>=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase \>10 mg/dL; or % bone marrow plasma cells: absolute value \>=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria
|
6.5 Percentage of participants
1.48
|
19.1 Percentage of participants
1.26
|
SECONDARY outcome
Timeframe: Baseline up to end of study (approximately 4 years 7 months)Population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Tumor response was assessed as PR based on IMWG response criteria as \>=50% reduction of serum and reduction in 24-h urinary M protein by \>=90% or to \<200 mg/24 h; or serum/urine M protein unmeasurable:\>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: \>=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was \>=30%; or plus if present at baseline: \>=50% reduction in size of soft tissue plasmocytomas.
Outcome measures
| Measure |
Bortezomib
n=46 Participants
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=47 Participants
no treatment, observation only
|
|---|---|---|
|
Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria
|
8.7 Percentage of participants
1.48
|
8.5 Percentage of participants
1.26
|
Adverse Events
Bortezomib
Non-treated Control
Serious adverse events
| Measure |
Bortezomib
n=51 participants at risk
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=53 participants at risk
no treatment, observation only
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
General disorders
Influenza like illness
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
General disorders
Pyrexia
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Hepatobiliary disorders
Acute hepatic failure
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Device related infection
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Pneumonia bacterial
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
Other adverse events
| Measure |
Bortezomib
n=51 participants at risk
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
|
Non-treated Control
n=53 participants at risk
no treatment, observation only
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.8%
6/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.8%
5/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Constipation
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Diarrhoea
|
37.3%
19/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Dyspepsia
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Nausea
|
17.6%
9/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Gastrointestinal disorders
Vomiting
|
15.7%
8/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
General disorders
Fatigue
|
13.7%
7/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
General disorders
Pyrexia
|
15.7%
8/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
3.8%
2/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Herpes zoster
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
5.7%
3/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
7.5%
4/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
6/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
7.5%
4/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
9/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
17.0%
9/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
3.9%
2/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
5.7%
3/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
9.4%
5/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
5/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
9.4%
5/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
7.5%
4/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.9%
2/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
5.7%
3/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Neuralgia
|
9.8%
5/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Neuropathy peripheral
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
1.9%
1/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Paraesthesia
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
5.7%
3/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.6%
10/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
3.8%
2/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Psychiatric disorders
Insomnia
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
3/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
9.4%
5/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
4/51 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
0.00%
0/53 • from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
|
Additional Information
EMEA Medical Affairs Director
Janssen-Cilag Greece
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the Sponsor for review at least 60 days prior to submission for publication or presentation. No paper that incorporates Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, such publication will be withheld for up to an additional 60 calendar days. A publication from the individual Study site data will not be published until the combined results have been published
- Publication restrictions are in place
Restriction type: OTHER