| Primary | Percentage of Participants With Overall Hematologic Response | Overall hematologic response was defined as the percentage of participants with complete response (CR), very good partial response (VGPR) and partial response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an adjudication committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of free light chain (FLC) ratio. VGPR: differential free light chain (difference between involved and uninvolved FLC levels; dFLC) < 40 mg/L. PR: ≥50% reduction in dFLC. Percentages were rounded off to the nearest decimal. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months. | | OG002 | Arm B: Dexamethasone + Cyclophosphamide | Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months. | | OG003 | Arm B: Dexamethasone + Thalidomide | Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months. | | OG004 | Arm B: Dexamethasone + Lenalidomide | Participants received dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
| | Units | Counts |
|---|
| Participants | - OG00085
- OG00124
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00053(41.8 to 63.9)
- OG00158(36.6 to 77.9)
- OG00230(6.7 to 65.2)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
- OG000
- OG001
- OG002
- OG003
- OG004
| Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure. | Cochran-Mantel-Haenszel | | =0.7623 | P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms. | Odds Ratio (OR) | 1.10 | | | 2-Sided | 95 | 0.60 | 2.01 | | | Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation. | |
|
| Primary | 2-Year Vital Organ (Heart or Kidney) Deterioration and Mortality Rate | Cardiac (Heart) deterioration was defined as the need for hospitalization for heart failure. Kidney deterioration was defined as progression to end-stage renal disease (ESRD) with the need for maintenance dialysis or renal transplantation. Vital organ deterioration was evaluated by an adjudication committee. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Percentage of Participants With Complete Hematologic Response | Complete hematologic response was defined as the percentage of participants with CR based on central laboratory results and the 2010 ISA Consensus Criteria as assessed by the investigator. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of FLC ratio. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | Full Range | months | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of randomization to the date of first documentation of hematologic disease progression, or organ (cardiac or renal) progression, or death due to any cause, whichever occurred first according to central laboratory results and ISA criteria as evaluated by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | Full Range | months | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Hematologic Disease Progression Free Survival | Hematologic disease PFS was defined as the time from the date of randomization to the date of first documentation of hematologic PD according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurred first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Median | Full Range | months | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Time to Vital Organ (Heart or Kidney) Deterioration and Mortality Rate | Time to vital organ deterioration or death was assessed by the investigator and defined as the time from randomization to vital organ (heart or kidney) deterioration or death, whichever occurs first. Cardiac deterioration is defined as the need for hospitalization for heart failure. Kidney deterioration is defined as progression to ESRD with the need for maintenance dialysis or renal transplantation. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | Full Range | months | | From randomization to time of vital organ deterioration or death (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Percentage of Participants With Best Vital Organ (Cardiac and/or Kidney) Response | Vital organ (heart and kidney) response rate was defined as the percentage of participants who achieved vital organ response according to central laboratory results and ISA criteria as evaluated by an adjudication committee. A vital organ response was defined as response of 1 or 2 of the involved vital organs with no change from Baseline in the rest of involved vital organs. Percentages were rounded off to the nearest decimal. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | |
|
| Secondary | Vital Organ Progression Free Survival | Vital organ PFS is defined as the time from the date of randomization to the date of first documentation of progression of vital organ (heart or kidney) according to central laboratory results and ISA criteria as evaluated by an adjudication committee, or death due to any cause, whichever occurs first. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | Full Range | months | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Duration of Hematologic Response | Duration of hematologic response (DOR) was defined as the time from the date of first documentation of a hematologic response to the date of first documented hematologic disease progression as determined by the investigator. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of hematologic responders. | Posted | | Median | Full Range | months | | From time of first documented response to disease progression (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or medically important event. | Safety Population included all participants who received at least 1 dose of any treatment drug. | Posted | | Count of Participants | | Participants | | From first dose of study drug through 30 days after administration of the last dose of study drug (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months. | | OG002 | Arm B: Dexamethasone + Cyclophosphamide | |
|
| Secondary | Time To Treatment Failure (TTF) | TTF was defined as the time from randomization to the date of first documented treatment failure. Treatment failure was defined as: 1) death due to any cause; 2) hematologic progression or major organ progression according to central laboratory results and ISA criteria as evaluated by the investigator; 3) clinically morbid organ disease requiring additional therapy; or 4) withdrawn for any reason. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | 95% Confidence Interval | months | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Time To Subsequent Anticancer Treatment | Time to subsequent anticancer therapy was defined as the time from randomization to the first date of subsequent anticancer therapy. Participants without subsequent anticancer therapy were censored at the date of death or last known to be alive. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. | Posted | | Median | Full Range | months | | From first dose of study drug until subsequent anticancer treatment (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Change From Baseline in 36-item Short Form General Health Survey (SF-36) Mental Component Summary Score at Week 28 of the PFS Follow-up | SF-36 Version 2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100, where higher scores are associated with less disability and better quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 28 of the PFS Follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | |
|
| Secondary | Change From Baseline in SF-36 Physical Component Summary Score at Week 28 of the PFS Follow-up | SF-36 Version 2 is a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100, where higher scores are associated with less disability and better quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 28 of the PFS Follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 |
|
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Score at Week 28 of the PFS Follow-up | The FACT/GOG-Ntx is a participant completed questionnaire that comprises 11 individual items evaluating symptoms of neurotoxicity on a 5-point scale where: 0=not at all (best) to 4=very much for a total possible score of 0 to 44. Symptom scores are inverted so that higher scores of FACT/GOG-Ntx indicate higher quality of life or functioning. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 28 of the PFS Follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Change From Baseline in Amyloidosis Symptom Scale Total Score at Week 28 of the PFS Follow-up | The amyloidosis symptom scale questionnaire is a participant completed questionnaire that evaluates symptom severity of 3 symptoms: Swelling, Shortness of Breath and Dizziness, each rated on an 11-point scale where: 0=no symptoms to 10=very severe symptoms. Higher scores indicate worsening of symptoms. Total Score is the sum of all responses from the amyloidosis symptom scale ranging from 0 to 30. Higher scores represent higher levels of symptomatology or problems and a negative change from baseline indicates improvement. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 28 of the PFS Follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | |
|
| Secondary | Number of Participants in Each Category of the EuroQol 5-Dimensional (EQ-5D) Questionnaire Score | The European Quality of Life (EuroQOL) 5-Dimensional (EQ-5D) is a patient completed questionnaire consisting of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 3 possible choices: no problems to extreme problems. Higher scores=worsening of the quality of life. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Count of Participants | | Participants | | At Week 28 of the OS follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analogue Scale Score | The EQ visual analogue scale (VAS) records the participant's self-rated health on a 20 centimeter vertical VAS that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the value collected at the time closest to, but prior to, the start of study drug administration. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | score on a scale | | At Week 28 of the OS follow-up | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|
| Secondary | Plasma Concentration of Ixazomib | As prespecified in the protocol, data for this outcome measure was planned to be collected for ixazomib arm group only. | Pharmacokinetic (PK) Analysis Population included participants with at least one PK sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Cycle 1, Day 1: 1, 4 hours postdose, Day 14: 144 hours postdose; Cycle 2, Day 1: predose, Day 14: 144 hours postdose; Cycles 3 to 10, Day 1: predose (cycle length=28 days) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. |
| |
| Secondary | Number of Hospitalizations | A hospitalization was defined as at least one overnight stay in an intensive care unit and/or non-intensive care unit. If a single hospitalization included both an intensive care unit stay and a non-intensive care unit stay, the hospitalization was counted only once (as an intensive care unit stay). The mean number of hospitalizations is reported in this outcome measure. As prespecified in the protocol, data was planned to be collected and analyzed in a combined way for non-ixazomib arm groups in this outcome measure. | ITT Population included all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | | Mean | Standard Deviation | hospitalizations | | From first dose of study drug until discontinuation of study drug due to disease progression or unacceptable toxicity, or death whichever occurs first (up to 115 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ixazomib + Dexamethasone | Participants received ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 and dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle for up to a maximum of 95.2 months. Dexamethasone was increased up to 40 mg/day after 4 weeks, if tolerated. | | OG001 | Arm B: Dexamethasone + Melphalan/Cyclophosphamide/Thalidomide/Lenalidomide | Participants received dexamethasone 20 mg, orally, and melphalan 0.22 mg/kg, orally once on Days 1 through 4 of each 28-day cycle, for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22, and cyclophosphamide 500 mg, orally, on Days 1, 8, and 15 of each 28-day cycle for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, and thalidomide daily at a starting dose of 50 mg and increased, as tolerated, to a maximum of 200 mg, orally for up to a maximum of 72.4 months OR dexamethasone 20 mg, orally, once weekly on Days 1, 8, 15, and 22 of each 28-day cycle and lenalidomide 15 mg, orally, once on Days 1 through 21 every 28 days for up to a maximum of 72.4 months. |
|