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Trial record 14 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00872521
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : May 7, 2013
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: PAD induction
Enrollment 107
Recruitment Details The participants were enrolled at multiple sites in Australia
Pre-assignment Details 107 participants were enrolled and they all received the study treatment.
Arm/Group Title 1q21 Amplified 1q21 Not Amplified Failed/Missing Test
Hide Arm/Group Description Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Period Title: Completed PAD Induction
Started 26 [1] 72 [1] 9 [1]
Completed 21 [2] 68 [2] 9 [2]
Not Completed 5 4 0
Reason Not Completed
Patient choice             0             1             0
Disease progression             0             2             0
Adverse Event             4             0             0
Death             1             1             0
[1]
Received allocated treatment
[2]
Completed PAD induction
Period Title: Primary Endpoint Analysis
Started 21 [1] 68 [1] 9 [1]
Completed 20 [2] 63 [2] 8 [2]
Not Completed 1 5 1
Reason Not Completed
Not specified             1             2             0
Patient choice             0             1             0
Efficacy data unavailable             0             2             0
Patient response missing             0             0             1
[1]
Completed PAD induction
[2]
participants analyzed
Period Title: Completed 3-month Follow up
Started 20 [1] 63 [1] 8 [1]
Completed 20 [2] 60 [2] 8 [2]
Not Completed 0 3 0
Reason Not Completed
Not specified             0             2             0
Physician Decision             0             1             0
[1]
Participants analyzed for primary endpoint
[2]
Completed 3-month follow-up
Period Title: Secondary Endpoint Analysis
Started 20 [1] 60 [1] 8 [1]
Completed 20 [2] 58 [2] 7 [2]
Not Completed 0 2 1
Reason Not Completed
Efficacy data unavailable             0             2             1
[1]
Completed 3-month follow-up
[2]
Participants analyzed for secondary endpoint
Arm/Group Title 1q21 Amplified 1q21 Not Amplified Failed/Missing Test Total
Hide Arm/Group Description Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Total of all reporting groups
Overall Number of Baseline Participants 26 72 9 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 72 participants 9 participants 107 participants
58.0  (7.6) 58.1  (10.1) 55.6  (8.1) 57.9  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 72 participants 9 participants 107 participants
Female
9
  34.6%
26
  36.1%
4
  44.4%
39
  36.4%
Male
17
  65.4%
46
  63.9%
5
  55.6%
68
  63.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 72 participants 9 participants 107 participants
White 23 63 8 94
Asian 1 2 0 3
Mauritian 1 0 0 1
Indian 0 1 0 1
Middle Eastern 0 0 1 1
South American 0 1 0 1
Appears White 1 4 0 5
Missing race 0 1 0 1
1.Primary Outcome
Title Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Hide Description International Myeloma Working Group (IMWG) criteria – CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.
Arm/Group Title 1q21 Not Amplified 1q21 Amplified Failed/Missing Test Total
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 63 20 8 91
Measure Type: Number
Unit of Measure: Participants
Non Responder 8 0 1 9
Responder 55 20 7 82
Total 63 20 8 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
Hide Description Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified Failed/Missing Total
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 63 20 8 91
Measure Type: Number
Unit of Measure: Particiipants
stringent complete response (sCR) 5 3 1 9
complete response (CR) 6 3 0 9
Very Good Partial Response (VGPR) 15 3 3 21
Partial Response (PR) 29 11 3 43
Stable Disease (SD) 8 0 1 9
Total 63 20 8 91
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
Hide Description Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.
Time Frame 3-months following ASCT
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified Failed/Missing Total
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 58 20 7 85
Measure Type: Number
Unit of Measure: Participants
Non Responder 4 0 0 4
Responder 54 20 7 81
Total 58 20 7 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
Hide Description Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.
Time Frame 3-months after ASCT
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified Failed/Missing Total
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 58 20 7 85
Measure Type: Number
Unit of Measure: Participants
stringent complete response (sCR) 6 5 3 14
complete response (CR) 8 3 0 11
Very Good Partial Response (VGPR) 21 7 1 29
Partial Response (PR) 19 5 3 27
Stable Disease (SD) 3 0 0 3
Relapse 1 0 0 1
Total 58 20 7 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Event Free Survival (EFS)
Hide Description Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 58 20
Measure Type: Number
Unit of Measure: Percentage of participants
75.0 69.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Overall Survival
Hide Description Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 58 20
Measure Type: Number
Unit of Measure: Percentage of participants
93.8 86.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1q21 Not Amplified, 1q21 Amplified
Comments Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Assessment of Quality of Life (AQoL) Scores
Hide Description The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
Arm/Group Title 1q21 Not Amplified 1q21 Amplified Failed/Missing Total
Hide Arm/Group Description:
Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
Overall Number of Participants Analyzed 42 19 8 69
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.0516596  (0.2769184) 0.0068695  (0.3366162) 0.1267145  (0.1839149) 0.0480281  (0.2844673)
8.Secondary Outcome
Title Overall Response Rate (ORR) Stratified by Protein Expression (p53)
Hide Description Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without p53 expression
Participants with p53 expression
Overall Number of Participants Analyzed 75 14
Measure Type: Number
Unit of Measure: Participants
p53 Non Responder 14 3
p53 Responder 61 11
9.Secondary Outcome
Title Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).
Hide Description Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without Cyclin D1 expression
Participants with Cyclin D1 expression
Overall Number of Participants Analyzed 59 25
Measure Type: Number
Unit of Measure: Participants
Cyclin D1 Non Responder 11 5
Cyclin D1 Responder 48 20
10.Secondary Outcome
Title Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)
Hide Description Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without bcl-2 expression
Participants with bcl-2 expression
Overall Number of Participants Analyzed 12 77
Measure Type: Number
Unit of Measure: Participants
bcl-2 Non Responder 2 15
bcl-2 Responder 10 62
11.Secondary Outcome
Title Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)
Hide Description Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)
Time Frame 84 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without FGFR3 expression
Participants with FGFR3 expression
Overall Number of Participants Analyzed 78 11
Measure Type: Number
Unit of Measure: Participants
FGFR3 Non Responder 14 2
FGFR3 Responder 64 8
12.Secondary Outcome
Title Overall Survival (OS) Stratified by Protein Expression (p53).
Hide Description Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without p53 expression
Participants with p53 expression
Overall Number of Participants Analyzed 65 13
Measure Type: Number
Unit of Measure: Percentage of participants
90.7 92.3
13.Secondary Outcome
Title Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)
Hide Description Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without Cyclin D1 expression
Participants with Cyclin D1 expression
Overall Number of Participants Analyzed 49 24
Measure Type: Number
Unit of Measure: Percentage of participants
89.8 95.8
14.Secondary Outcome
Title Overall Survival (OS) Stratified by Protein Expression (Bcl-2)
Hide Description Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without bcl-2 expression
Participants with bcl-2 expression
Overall Number of Participants Analyzed 12 66
Measure Type: Number
Unit of Measure: Percentage of participants
91.7 90.9
15.Secondary Outcome
Title Overall Survival (OS) Stratified by Protein Expression (FGFR3)
Hide Description Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).
Time Frame 2 years after Day 1 Cycle 1 of PAD
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.
Arm/Group Title Negative Positive
Hide Arm/Group Description:
Participants without FGFR3 expression
Participants with FGFR3 expression
Overall Number of Participants Analyzed 67 11
Measure Type: Number
Unit of Measure: Percentage of participants
92.5 81.8
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1q21 Amplified 1q21 Not Amplified Failed/Missing Test Total
Hide Arm/Group Description Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
All-Cause Mortality
1q21 Amplified 1q21 Not Amplified Failed/Missing Test Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1q21 Amplified 1q21 Not Amplified Failed/Missing Test Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/26 (57.69%)   30/72 (41.67%)   5/9 (55.56%)   50/107 (46.73%) 
Blood and lymphatic system disorders         
Anaemia  1  1/26 (3.85%)  0/72 (0.00%)  1/9 (11.11%)  2/107 (1.87%) 
Febrile Neutropenia  1  1/26 (3.85%)  1/72 (1.39%)  0/9 (0.00%)  2/107 (1.87%) 
Cardiac disorders         
Atrial Fibrillation  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Cardiac Amyloidosis  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Cardiac Failure  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Cardiac Failure Congestive  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Cardiomyopathy  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Ventricular Arrhythmia  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Endocrine disorders         
Hyperthyroidism  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Gastrointestinal disorders         
Abdominal Pain  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Abdominal Strangulated Hernia  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Constipation  1  0/26 (0.00%)  6/72 (8.33%)  0/9 (0.00%)  6/107 (5.61%) 
Diarrhoea  1  0/26 (0.00%)  3/72 (4.17%)  0/9 (0.00%)  3/107 (2.80%) 
Large Intestinal Obstruction  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Mouth Ulceration  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Nausea  1  0/26 (0.00%)  5/72 (6.94%)  0/9 (0.00%)  5/107 (4.67%) 
Vomiting  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
General disorders         
Chest Pain  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Fatigue  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Gait Disturbance  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Oedema  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Pyrexia  1  2/26 (7.69%)  5/72 (6.94%)  2/9 (22.22%)  9/107 (8.41%) 
Infections and infestations         
Cellulitis  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Device Related Infection  1  1/26 (3.85%)  1/72 (1.39%)  0/9 (0.00%)  2/107 (1.87%) 
H1N1 Influenza  1  2/26 (7.69%)  0/72 (0.00%)  0/9 (0.00%)  2/107 (1.87%) 
Herpes Zoster  1  0/26 (0.00%)  1/72 (1.39%)  1/9 (11.11%)  2/107 (1.87%) 
Herpes Zoster Ophthalmic  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Infection  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Influenza  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Lower Respiratory Tract Infection  1  0/26 (0.00%)  5/72 (6.94%)  0/9 (0.00%)  5/107 (4.67%) 
Pneumonia  1  2/26 (7.69%)  6/72 (8.33%)  2/9 (22.22%)  10/107 (9.35%) 
Pneumonia Viral  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Sinusitis  1  2/26 (7.69%)  0/72 (0.00%)  0/9 (0.00%)  2/107 (1.87%) 
Streptococcal Infection  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Urinary Tract Infection  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Injury, poisoning and procedural complications         
Fall  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Overdose  1  0/26 (0.00%)  0/72 (0.00%)  1/9 (11.11%)  1/107 (0.93%) 
Urinary Retention Postoperative  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Investigations         
Blood Creatine Increased  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Blood Sodium Decreased  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Cardioactive Drug Level Increased  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Chest X-Ray Abnormal  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  2/26 (7.69%)  0/72 (0.00%)  0/9 (0.00%)  2/107 (1.87%) 
Dehydration  1  2/26 (7.69%)  5/72 (6.94%)  0/9 (0.00%)  7/107 (6.54%) 
Musculoskeletal and connective tissue disorders         
Back Pain  1  3/26 (11.54%)  3/72 (4.17%)  0/9 (0.00%)  6/107 (5.61%) 
Muscle Spasms  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Muscular Weakness  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Musculoskeletal Chest Pain  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Musculoskeletal Pain  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate Cancer  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Nervous system disorders         
Autonomic Neuropathy  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Cerebrovascular Accident  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Dizziness  1  1/26 (3.85%)  1/72 (1.39%)  0/9 (0.00%)  2/107 (1.87%) 
Facial Palsy  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Neuralgia  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Neuropathy Peripheral  1  1/26 (3.85%)  2/72 (2.78%)  0/9 (0.00%)  3/107 (2.80%) 
Presyncope  1  0/26 (0.00%)  2/72 (2.78%)  0/9 (0.00%)  2/107 (1.87%) 
Syncope  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Psychiatric disorders         
Delirium  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Renal and urinary disorders         
Renal Failure Acute  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Urinary Retention  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  2/26 (7.69%)  0/72 (0.00%)  0/9 (0.00%)  2/107 (1.87%) 
Pulmonary Embolism  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Skin and subcutaneous tissue disorders         
Acute Febrile Neutrophilic Dermatosis  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Rash  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Surgical and medical procedures         
Pain Management  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Vascular disorders         
Circulatory Collapse  1  0/26 (0.00%)  1/72 (1.39%)  0/9 (0.00%)  1/107 (0.93%) 
Hypotension  1  1/26 (3.85%)  0/72 (0.00%)  0/9 (0.00%)  1/107 (0.93%) 
Orthostatic Hypotension  1  0/26 (0.00%)  1/72 (1.39%)  1/9 (11.11%)  2/107 (1.87%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1q21 Amplified 1q21 Not Amplified Failed/Missing Test Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   72/72 (100.00%)   9/9 (100.00%)   107/107 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  8/26 (30.77%)  15/72 (20.83%)  3/9 (33.33%)  26/107 (24.30%) 
Neutropenia  1  6/26 (23.08%)  12/72 (16.67%)  0/9 (0.00%)  18/107 (16.82%) 
Eye disorders         
Vision Blurred  1  2/26 (7.69%)  6/72 (8.33%)  2/9 (22.22%)  10/107 (9.35%) 
Gastrointestinal disorders         
Abdominal Pain  1  2/26 (7.69%)  5/72 (6.94%)  1/9 (11.11%)  8/107 (7.48%) 
Constipation  1  17/26 (65.38%)  42/72 (58.33%)  6/9 (66.67%)  65/107 (60.75%) 
Diarrhoea  1  9/26 (34.62%)  26/72 (36.11%)  3/9 (33.33%)  38/107 (35.51%) 
Dyspepsia  1  3/26 (11.54%)  9/72 (12.50%)  1/9 (11.11%)  13/107 (12.15%) 
Gastrooesophageal Reflux Disease  1  4/26 (15.38%)  7/72 (9.72%)  0/9 (0.00%)  11/107 (10.28%) 
Nausea  1  10/26 (38.46%)  36/72 (50.00%)  5/9 (55.56%)  51/107 (47.66%) 
Reflux Gastritis  1  1/26 (3.85%)  5/72 (6.94%)  0/9 (0.00%)  6/107 (5.61%) 
Vomiting  1  1/26 (3.85%)  15/72 (20.83%)  1/9 (11.11%)  17/107 (15.89%) 
General disorders         
Chest Pain  1  1/26 (3.85%)  8/72 (11.11%)  0/9 (0.00%)  9/107 (8.41%) 
Fatigue  1  7/26 (26.92%)  30/72 (41.67%)  4/9 (44.44%)  41/107 (38.32%) 
Mucosal Inflammation  1  2/26 (7.69%)  7/72 (9.72%)  1/9 (11.11%)  10/107 (9.35%) 
Oedema  1  3/26 (11.54%)  4/72 (5.56%)  0/9 (0.00%)  7/107 (6.54%) 
Oedema Peripheral  1  5/26 (19.23%)  12/72 (16.67%)  2/9 (22.22%)  19/107 (17.76%) 
Pain  1  1/26 (3.85%)  8/72 (11.11%)  1/9 (11.11%)  10/107 (9.35%) 
Pyrexia  1  1/26 (3.85%)  5/72 (6.94%)  1/9 (11.11%)  7/107 (6.54%) 
Infections and infestations         
Lower Respiratory Tract Infection  1  2/26 (7.69%)  9/72 (12.50%)  0/9 (0.00%)  11/107 (10.28%) 
Upper Respiratory Tract Infection  1  0/26 (0.00%)  8/72 (11.11%)  1/9 (11.11%)  9/107 (8.41%) 
Metabolism and nutrition disorders         
Decreased Appetite  1  4/26 (15.38%)  11/72 (15.28%)  1/9 (11.11%)  16/107 (14.95%) 
Hypocalcaemia  1  2/26 (7.69%)  4/72 (5.56%)  0/9 (0.00%)  6/107 (5.61%) 
Hypokalaemia  1  4/26 (15.38%)  3/72 (4.17%)  0/9 (0.00%)  7/107 (6.54%) 
Hypomagnesaemia  1  4/26 (15.38%)  4/72 (5.56%)  0/9 (0.00%)  8/107 (7.48%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/26 (3.85%)  5/72 (6.94%)  1/9 (11.11%)  7/107 (6.54%) 
Back Pain  1  3/26 (11.54%)  15/72 (20.83%)  0/9 (0.00%)  18/107 (16.82%) 
Bone Pain  1  1/26 (3.85%)  4/72 (5.56%)  1/9 (11.11%)  6/107 (5.61%) 
Muscle Spasms  1  4/26 (15.38%)  5/72 (6.94%)  0/9 (0.00%)  9/107 (8.41%) 
Musculoskeletal Chest Pain  1  1/26 (3.85%)  9/72 (12.50%)  0/9 (0.00%)  10/107 (9.35%) 
Pain in Extremity  1  5/26 (19.23%)  8/72 (11.11%)  1/9 (11.11%)  14/107 (13.08%) 
Nervous system disorders         
Areflexia  1  2/26 (7.69%)  6/72 (8.33%)  1/9 (11.11%)  9/107 (8.41%) 
Dizziness  1  1/26 (3.85%)  14/72 (19.44%)  1/9 (11.11%)  16/107 (14.95%) 
Dysgeusia  1  8/26 (30.77%)  14/72 (19.44%)  3/9 (33.33%)  25/107 (23.36%) 
Headache  1  4/26 (15.38%)  14/72 (19.44%)  0/9 (0.00%)  18/107 (16.82%) 
Lethargy  1  6/26 (23.08%)  11/72 (15.28%)  0/9 (0.00%)  17/107 (15.89%) 
Neuralgia  1  3/26 (11.54%)  14/72 (19.44%)  1/9 (11.11%)  18/107 (16.82%) 
Neuropathy Peripheral  1  15/26 (57.69%)  36/72 (50.00%)  3/9 (33.33%)  54/107 (50.47%) 
Peripheral Sensory Neuropathy  1  1/26 (3.85%)  16/72 (22.22%)  1/9 (11.11%)  18/107 (16.82%) 
Psychiatric disorders         
Anxiety  1  3/26 (11.54%)  5/72 (6.94%)  0/9 (0.00%)  8/107 (7.48%) 
Insomnia  1  9/26 (34.62%)  27/72 (37.50%)  3/9 (33.33%)  39/107 (36.45%) 
Mood Altered  1  2/26 (7.69%)  5/72 (6.94%)  1/9 (11.11%)  8/107 (7.48%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/26 (3.85%)  11/72 (15.28%)  4/9 (44.44%)  16/107 (14.95%) 
Dyspnoea  1  6/26 (23.08%)  10/72 (13.89%)  0/9 (0.00%)  16/107 (14.95%) 
Hiccups  1  2/26 (7.69%)  5/72 (6.94%)  2/9 (22.22%)  9/107 (8.41%) 
Oropharyngeal Pain  1  1/26 (3.85%)  5/72 (6.94%)  1/9 (11.11%)  7/107 (6.54%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  3/26 (11.54%)  20/72 (27.78%)  2/9 (22.22%)  25/107 (23.36%) 
Rash  1  8/26 (30.77%)  11/72 (15.28%)  1/9 (11.11%)  20/107 (18.69%) 
Vascular disorders         
Orthostatic Hypotension  1  3/26 (11.54%)  6/72 (8.33%)  0/9 (0.00%)  9/107 (8.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Regional Medical Affairs Director Asia Pacific
Organization: Jan-Cil Australia
Phone: 61 427564369
Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00872521     History of Changes
Other Study ID Numbers: CR015640
26866138MMY2059 ( Other Identifier: Janssen-Cilag Pty Ltd, Australia )
PIMMS Trial ( Other Identifier: Janssen-Cilag Pty Ltd, Australia )
First Submitted: March 27, 2009
First Posted: March 31, 2009
Results First Submitted: December 14, 2012
Results First Posted: May 7, 2013
Last Update Posted: May 16, 2014