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| ID | Type | Description | Link |
|---|---|---|---|
| 26866138MMY2059 | Other Identifier | Janssen-Cilag Pty Ltd, Australia | |
| PIMMS Trial | Other Identifier | Janssen-Cilag Pty Ltd, Australia |
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The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma.
This is an open-label, single-arm, multicentre study which will enroll approximately 105 patients. Open-label means all people involved in the study know the identity of the intervention. Single-arm means there is one group of patients, all receiving the same treatment. Four 21-day cycles of a combination of bortezomib i.v. (intravenous) 1.3 mg/m2 (Days 1, 4, 8 and 11), doxorubicin i.v. 20 mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12) (PAD) will be given. Patients will be discontinued if disease progresses, or unacceptable treatment-related toxicity occurs. Following PAD treatment, patients will have peripheral blood stem cells (PBSC) collected, and an autologous stem cell transplant (ASCT) will be performed. Patients will then make monthly visits to the Study Doctor until 1 year after start of treatment, and attend a final follow-up visit at 2 years. Efficacy assessment of response to PAD will be made using the International Myeloma Working Group (IMWG) criteria. The primary outcome is to compare the overall response rate following 4 cycles of PAD induction therapy between patients with and without extra copies of the long arm of the first chromosome (1q21) measured by fluorescent in situ hybridisation (FISH) in their marrow at baseline. Patient reported outcomes will be assessed using the AQoL (Assessment of Quality of Life). Safety will be evaluated throughout the study by assessment of adverse events including changes in physical examination, concomitant medication, ECOG (Eastern Cooperative Oncology Group) scores, vital signs and clinical laboratory findings. A sample size of 105 provides 80% power (a=0.05) to detect a difference in overall response rate of 28% at the end of 4 cycles of PAD. This is based on the assumptions that 44% of patients have amplification of 1q21 1, 2, the overall response rate with PAD combination therapy is 80%; the overall response rate with PAD if PAD therapy does not overcome 1q21 amplification is assumed to be 64%, while without 1q21 amplification it is assumed to be 92%. That is: Overall Response Rate (ORR) = P1q21 amplified x ORRamplified + P1q21 not amplified x ORRnot amplified i.e. 80% = 44% x 64% + 56% x 92%. The sample size of 105 allows for a 20% drop-out rate. Four 21-day cycles of PAD: a combination of bortezomib i.v. (intravenous) 1.3 mg/m2 (Days 1, 4, 8 and 11), doxorubicin i.v. 20 mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bortezomib; doxorubicin; dexamethasone | Experimental | PAD induction Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1 4 8 & 11) Doxorubicin 20 mg/m2 i.v. (D1 & 4) Dexamethasone 20 mg p.o. (D1 2 4 5 8 9 11 & 12) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAD induction | Drug | Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 & 11), Doxorubicin 20 mg/m2 i.v. (D1 & 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 & 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction | Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD). | 84 days |
| Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | Australia | |||||
107 participants were enrolled and they all received the study treatment.
The participants were enrolled at multiple sites in Australia
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| ID | Title | Description |
|---|---|---|
| FG000 | 1q21 Amplified | 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. |
| FG001 | 1q21 Not Amplified |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Completed PAD Induction |
|
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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. |
| 3-months following ASCT |
| Disease Response 3-months After Autologous Stem Cell Transplant (ASCT) | 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. | 3-months after ASCT |
| Event Free Survival (EFS) | 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). | 2 years after Day 1 Cycle 1 of PAD |
| Overall Survival | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD). | 2 years after Day 1 Cycle 1 of PAD |
| Assessment of Quality of Life (AQoL) Scores | 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). | Up to 2 years |
| Overall Response Rate (ORR) Stratified by Protein Expression (p53) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53). | 84 days |
| Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1). | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1). | 84 days |
| Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2) | 84 days |
| Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3) | 84 days |
| Overall Survival (OS) Stratified by Protein Expression (p53). | 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). | 2 years after Day 1 Cycle 1 of PAD |
| Overall Survival (OS) Stratified by Protein Expression (Cyclin D1) | 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). | 2 years after Day 1 Cycle 1 of PAD |
| Overall Survival (OS) Stratified by Protein Expression (Bcl-2) | 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). | 2 years after Day 1 Cycle 1 of PAD |
| Overall Survival (OS) Stratified by Protein Expression (FGFR3) | 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). | 2 years after Day 1 Cycle 1 of PAD |
| Box Hill |
| Australia |
| Brisbane | Australia |
| Camperdown | Australia |
| Geelong | Australia |
| Gosford | Australia |
| Greenslopes | Australia |
| Malvern | Australia |
| Melbourne | Australia |
| Parkville | Australia |
| Perth | Australia |
| Sydney | Australia |
| Westmead | Australia |
| Woden | Australia |
| Wollongong | Australia |
| Woolloongabba | Australia |
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. |
| FG002 | Failed/Missing Test | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Primary Endpoint Analysis |
|
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| Completed 3-month Follow up |
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| Secondary Endpoint Analysis |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1q21 Amplified | 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. |
| BG001 | 1q21 Not Amplified | 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. |
| BG002 | Failed/Missing Test | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction. | Posted | Number | Participants | 84 days |
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| Secondary | Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction | Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Number | Particiipants | 84 days |
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| Secondary | Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT). | 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. | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Number | Participants | 3-months following ASCT |
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| Secondary | Disease Response 3-months After Autologous Stem Cell Transplant (ASCT) | 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. | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Number | Participants | 3-months after ASCT |
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| Secondary | Event Free Survival (EFS) | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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| Secondary | Overall Survival | Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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| Secondary | Assessment of Quality of Life (AQoL) Scores | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD | Posted | Mean | Standard Deviation | Scores on a scale | Up to 2 years |
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| Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (p53) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53). | 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. | Posted | Number | Participants | 84 days |
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| Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1). | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1). | 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. | Posted | Number | Participants | 84 days |
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| Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2) | 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. | Posted | Number | Participants | 84 days |
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| Secondary | Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3) | Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3) | 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. | Posted | Number | Participants | 84 days |
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| Secondary | Overall Survival (OS) Stratified by Protein Expression (p53). | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed. | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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| Secondary | Overall Survival (OS) Stratified by Protein Expression (Cyclin D1) | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed. | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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| Secondary | Overall Survival (OS) Stratified by Protein Expression (Bcl-2) | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed. | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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| Secondary | Overall Survival (OS) Stratified by Protein Expression (FGFR3) | 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). | Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed. | Posted | Number | Percentage of participants | 2 years after Day 1 Cycle 1 of PAD |
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|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1q21 Amplified | 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. | 15 | 26 | 26 | 26 | ||
| EG001 | 1q21 Not Amplified | 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. | 30 | 72 | 72 | 72 | ||
| EG002 | Failed/Missing Test | 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. | 5 | 9 | 9 | 9 | ||
| EG003 | Total | 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. | 50 | 107 | 107 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cardiac Amyloidosis | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Gait Disturbance | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Device Related Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| H1N1 Influenza | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
| |
| Herpes Zoster Ophthalmic | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Pneumonia Viral | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Streptococcal Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Systematic Assessment |
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| Urinary Retention Postoperative | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Systematic Assessment |
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| Blood Creatine Increased | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| Blood Sodium Decreased | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| Cardioactive Drug Level Increased | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| Chest X-Ray Abnormal | Investigations | MedDRA Version 13.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Systematic Assessment |
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| Autonomic Neuropathy | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Facial Palsy | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Acute Febrile Neutrophilic Dermatosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pain Management | Surgical and medical procedures | MedDRA Version 13.0 | Systematic Assessment |
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| Circulatory Collapse | Vascular disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Reflux Gastritis | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Areflexia | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Mood Altered | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA Version 13.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regional Medical Affairs Director Asia Pacific | Jan-Cil Australia | 61 427564369 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Efficacy data unavailable |
|
| Patient response missing |
|
| Male |
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| Asian |
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| Mauritian |
|
| Indian |
|
| Middle Eastern |
|
| South American |
|
| Appears White |
|
| Missing race |
|
| Responder |
|
| Total |
|
| OG003 | Total | 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. |
|
|
|
| OG003 | Total | 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. |
|
|
|
| OG003 | Total | 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. |
|
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|
|
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| OG003 | Total | 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. |
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