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| ID | Type | Description | Link |
|---|---|---|---|
| 26866138-MMY-2073 | Other Identifier | Janssen Asia-Pacific Medical Affairs |
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The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.
This is an open-label (patients will know the identity of study treatments), randomized (patients will be assigned by chance to different treatments) study of bortezomib administered as consolidation therapy (therapy given once a remission is achieved) with thalidomide and prednisolone versus thalidomide and prednisolone alone in previously untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells, a type of white blood cell present in your bone marrow. Patients in this study will receive initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure where patients receive an infusion of immature blood cells [stem cells] from their own body to replenish the body's supply of healthy blood-forming cells) before randomization to one of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression and prednisolone on alternate days continued indefinitely or until disease progression) or Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until disease progression and prednisolone on alternate days, continued indefinitely or until disease progression.
Throughout the study, the patient's response to therapy will be assessed according to protocol-defined efficacy evaluations and by implementing defined disease response criteria (International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be conducted from time of randomization to 3 years post-randomization.
Two interim analyses are planned. The final analysis will be conducted after all patients have completed 12-month consolidation treatment phase or discontinued. The primary endpoint of number and percent of patients with complete response and very good partial response defined by IMWG criteria for multiple myeloma will be examined in the interim and final analyses after approximately 12 months of consolidation therapy. At the completion of the study, updated analyses of PFS and OS will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction] | Experimental | Bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase. |
|
| Thalidomide + Prednisolone [TP Consolidation] | Experimental | Thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression. |
|
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | Experimental | Bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug | Thalidomide 100 mg tablet, orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 | CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 | CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. | Months 3, 6, 9 and 12 |
| Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Asia-Pacific Medical Affairs Clinical Trial | Janssen Asia-Pacific Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30777794 | Derived | Horvath N, Spencer A, Kenealy M, Joshua D, Campbell PJ, Lee JJ, Hou J, Qiu L, Kalff A, Khong T, Londhe A, Siggins S, van Kooten Losio M, Eisbacher M, Prince HM. Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Leuk Lymphoma. 2019 Sep;60(9):2122-2133. doi: 10.1080/10428194.2019.1579322. Epub 2019 Feb 19. |
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The study consisted of 2 treatment phases: induction and consolidation. Participants who completed the induction phase were randomized to enter in the consolidation treatment phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction) | Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Before Randomization (VCD Induction) |
|
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| Bortezomib | Drug | Bortezomib 1.3 milligram per square meter (mg/m^2) solution for injection subcutaneously (SC). |
|
| Cyclophosphamide | Drug | Cyclophosphamide 300 mg/m^2 orally. |
|
| Dexamethasone | Drug | Dexamethasone 20 mg orally. |
|
| Prednisolone | Drug | Prednisolone 50 mg orally. |
|
sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. |
| Months 3, 6, 9 and 12 |
| Progression Free Survival (PFS) | PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder. | Baseline until progressive disease (up to 5 years) |
| Disease-free Survival (DFS) | DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia). | Up to 5 years |
| Overall Survival (OS) | OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event. | Up to 5 years |
| Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase | The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL). | Baseline, Month 12 |
| Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life. | Baseline, Month 12 |
| Camperdown |
| Australia |
| Geelong | Australia |
| Greenslopes | Australia |
| Heidelberg | Australia |
| Herston | Australia |
| Malvern | Australia |
| Melbourne | Australia |
| Nedlands | Australia |
| Newcastle | Australia |
| Prahran | Australia |
| Sydney | Australia |
| Westmead | Australia |
| Woodville South | Australia |
| Woolloongabba | Australia |
| Beijing | China |
| Guangzhou | China |
| Shanghai | China |
| Tianjin | China |
| Busan | South Korea |
| Daegu | South Korea |
| Jeollanam-do | South Korea |
| Ulsan | South Korea |
| FG001 | Thalidomide + Prednisolone (TP Consolidation) | Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression. |
| FG002 | Bortezomib + Thalidomide + Prednisolone (VTP Consolidation) | Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| After Randomization (TP and VTP) |
|
|
Baseline population was defined as all enrolled participants who received at least 1 non-zero dose of any study drug in the induction phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction) | Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 | CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours. | All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment. | Posted | Number | percentage of participants | Month 12 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 | CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. | All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment. | Posted | Number | percentage of participants | Months 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. | All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment. | Posted | Number | percentage of participants | Months 3, 6, 9 and 12 |
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder. | All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment. | Posted | Median | 95% Confidence Interval | months | Baseline until progressive disease (up to 5 years) |
| ||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival (DFS) | DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia). | Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, 'N' (number of participants analyzed) signifies the participants who had complete response. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event. | All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment. | Posted | Median | 95% Confidence Interval | months | Up to 5 years |
| ||||||||||||||||||||||||||||||
| Secondary | Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase | The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL). | All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life. | All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 12 |
|
Not provided
Safety population included all participants in the induction and consolidation phase who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bortezomib + Cyclophosphamide + Dexamethasone (VCD Induction) | Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 milligram (mg) orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase. | 88 | 254 | 233 | 254 | ||
| EG001 | Thalidomide + Prednisolone (TP Consolidation) | Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression. | 22 | 99 | 95 | 99 | ||
| EG002 | Bortezomib + Thalidomide + Prednisolone (VTP Consolidation) | Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression. | 28 | 103 | 96 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Oesophageal Spasm | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Bacillus Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Device Related Sepsis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Herpes Zoster Disseminated | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonia Influenzal | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonia Primary Atypical | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Test Positive | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Embolic Stroke | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diaphragmatic Paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Circulatory Collapse | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Embolism Venous | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Injection Site Rash | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Mood Altered | Psychiatric disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Janssen R&D | ClinicalTrialDisclosure@its.jnj.com |
| 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
| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Adverse Event |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Progressive Disease |
|
| Death |
|
| Republic of Korea |
|
|
|
|
|
| OG001 | Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression. |
|
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|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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