Trial Outcomes & Findings for A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma (NCT NCT03170882)

Last Updated: 2022-12-20

Results Overview

PFS: Time from randomization to first occurrence of confirmed progressive disease (PD) as assessed by investigator by International Myeloma Working Group(IMWG) response criteria/death from any cause, whichever occurs first. PD requires following: Increase of \>=25 % from nadir in: Serum M component (increase must be \>=0.5 gram per deciliter \[g/dl\]); Urine M-component (increase must be \>=200 milligram \[mg\]/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved free light chain (FLC) increase of \>10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: bone marrow plasma cell percentage must be \>=10%; Development of new/increase in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia (\>11.5mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)

Results posted on

2022-12-20

Participant Flow

Participants took part in the study at 54 investigative sites in Australia, Turkey, Czech Republic, France, Germany, Italy, Netherlands, Norway, Spain, Israel, United Kingdom, Sweden, Greece, and Russian Federation from 01 August 2017 up to 26 November 2021.

Participants with a diagnosis of relapsed and/or refractory multiple myeloma (RRMM) who received at least 2 prior lines of therapy were enrolled in 2:3 ratio to receive pomalidomide + dexamethasone or ixazomib + dexamethasone in this study.

Participant milestones

Participant milestones
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Overall Study STARTED	49	73
Overall Study Treated: Safety Population	47	72
Overall Study ITT PRO Population	45	70
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	49	73

Reasons for withdrawal

Reasons for withdrawal
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Overall Study Death	17	29
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	4	7
Overall Study Reason not Specified	28	36

Baseline Characteristics

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Total n=122 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 8.33 • n=5 Participants	70.6 years STANDARD_DEVIATION 8.60 • n=7 Participants	69.4 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	38 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	35 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	65 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	69 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Russia	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Norway	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Italy	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment France	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Ireland	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Germany	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Turkey	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Spain	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Israel	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Czechia	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Netherlands	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Greece	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Sweden	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Australia	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Baseline Height	166.59 cm STANDARD_DEVIATION 8.740 • n=5 Participants	165.01 cm STANDARD_DEVIATION 10.475 • n=7 Participants	165.65 cm STANDARD_DEVIATION 9.808 • n=5 Participants
Baseline Weight	75.75 kg STANDARD_DEVIATION 16.160 • n=5 Participants	74.36 kg STANDARD_DEVIATION 17.426 • n=7 Participants	74.92 kg STANDARD_DEVIATION 16.875 • n=5 Participants
Baseline Body Surface Area	1.864 m^2 STANDARD_DEVIATION 0.2203 • n=5 Participants	1.837 m^2 STANDARD_DEVIATION 0.2430 • n=7 Participants	1.848 m^2 STANDARD_DEVIATION 0.2336 • n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)

Population: ITT Population included all participants who were randomized. Participants without documentation of PD were censored at the date of last response assessment that is stable disease (SD) or better.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Progression Free Survival (PFS)	4.8 months Interval 3.745 to 8.542	7.1 months Interval 3.943 to 11.138

SECONDARY outcome

Timeframe: From date of randomization to death due to any cause (Up to approximately 3 years)

Population: ITT Population included all participants who were randomized. Participants without documented death at the time of analysis were censored at the date last known to be alive.

OS was defined as the time from randomization to death from any cause, up to 3 years are reported.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Overall Survival (OS)	NA months Interval 13.963 to Median and upper limit of 95% confidence interval (CI) were not estimable due to low number of participants with events.	18.8 months Interval 10.973 to Upper limit of 95% CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)

Population: ITT Population included all participants who were randomized.

Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: \>=50% reduction of serum M protein + reduction in 24-hour urinary M protein by \>=90% or to \<200 mg/24-hour; if M protein is not measurable, \>=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, \>=50% reduction in bone marrow plasma cells, when baseline value \>=30% and; if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; \<5 % plasma cells in bone marrow.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Percentage of Participants With Overall Response	41 percentage of participants Interval 27.0 to 56.0	38 percentage of participants Interval 27.0 to 50.0

SECONDARY outcome

Timeframe: From date of first documentation of CR, VGPR or PR until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)

Population: Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR. Only responders were reported for this outcome measure.

DOR: Time from first documentation of CR/PR/VGPR to first documentation of PD. Per IMWG criteria, PR:\>=50% reduction of serum M protein+reduction in 24-hour urinary M protein by \>=90% to \<200 mg/24-hour or \>=50% decrease in difference between involved and uninvolved FLC levels/ \>=50% reduction in bone marrow plasma cells, if \>=30% at Baseline/ \>=50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24-hour. CR:negative immunofixation on serum + urine+disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow. PD:serum M-component increase \>=0.5 g/dl or urine M-component increase \>=200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \>10 mg/dl or bone marrow plasma cell \>=10%/development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=20 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=28 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Duration of Response (DOR)	14.3 months Interval 3.713 to Upper limit of 95% CI was not estimable due to low number of responders with events.	14.8 months Interval 10.152 to 19.614

SECONDARY outcome

Timeframe: From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)

Population: Response Evaluable Population included all participants with multiple myeloma who had documentation of a confirmed PR, or PR/VGPR/CR.

Time to response was defined as the time from randomization to the first documentation of PR/VGPR/CR. Per IMWG criteria, PR: \>=50% reduction of serum M protein + reduction in 24-hour urinary M protein by \>=90% or to \<200 mg/24-hour; if M-protein is not measurable, \>=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, \>=50% reduction in bone marrow plasma cells, when Baseline value \>=30% and; if present at Baseline, \>=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein + urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum + urine; disappearance of soft tissue plasmacytomas; \<5% plasma cells in bone marrow.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Time to Response	1.1 months Interval 0.953 to 2.037	2.0 months Interval 1.906 to 2.858

SECONDARY outcome

Timeframe: From date of randomization until first occurrence of confirmed disease progression or death due to any cause, whichever occurs first (Up to approximately 3 years)

Population: ITT Population included all participants who were randomized. Participants without documentation of PD at the time of analysis are censored at the date of last response assessment that is SD or better.

TTP was defined as the time from the date of randomization to first documentation of PD. Per IMWG criteria, PD required 1 of the following: Increase of \>=25% from nadir in: Serum M-component (increase must be \>=0.5 g/dl; Urine M-component (increase must be \>=200 mg/24-hour); In participants without measurable serum and urine M-protein levels difference between involved and uninvolved FLC levels increase of \>10 mg/dl; In participants without measurable serum and urine M protein levels and without measurable disease by FLC level: Bone marrow plasma cell percentage must be \>=10%; Development of new or increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (\>11.5 mg/dL corrected serum calcium) attributed solely to plasma cell proliferative disease.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Time to Progression (TTP)	5.1 months Interval 3.844 to 12.485	8.4 months Interval 5.684 to 13.306

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)

Population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC Multiple Myeloma Module 20 \[QLQ-MY20\] and EuroQol 5-Dimensional Health Questionnaire \[EQ-5D-5L\]). Number analyzed are the number of participants with data available for analyses at the given timepoint.

The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=45 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=70 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score End of Treatment	52.4 score on a scale Standard Deviation 28.03	56.5 score on a scale Standard Deviation 26.10
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score Baseline	67.0 score on a scale Standard Deviation 21.97	67.9 score on a scale Standard Deviation 22.08

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)

Population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.

The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=45 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=70 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
HRQOL Based on EORTC QLQ-C30 SubScale Score Role (Functional Scale): Baseline	67.4 score on a scale Standard Deviation 28.42	67.9 score on a scale Standard Deviation 29.67
HRQOL Based on EORTC QLQ-C30 SubScale Score Role (Functional Scale): End of Treatment	47.6 score on a scale Standard Deviation 27.86	49.2 score on a scale Standard Deviation 27.04
HRQOL Based on EORTC QLQ-C30 SubScale Score Emotional (Functional Scale): End of Treatment	67.6 score on a scale Standard Deviation 25.19	72.8 score on a scale Standard Deviation 22.62
HRQOL Based on EORTC QLQ-C30 SubScale Score Cognitive(Functional Scale): Baseline	79.6 score on a scale Standard Deviation 20.38	84.0 score on a scale Standard Deviation 20.74
HRQOL Based on EORTC QLQ-C30 SubScale Score Cognitive (Functional Scale): End of Treatment	69.6 score on a scale Standard Deviation 27.61	77.4 score on a scale Standard Deviation 22.64
HRQOL Based on EORTC QLQ-C30 SubScale Score Social (Functional Scale): Baseline	72.2 score on a scale Standard Deviation 29.94	75.7 score on a scale Standard Deviation 27.02
HRQOL Based on EORTC QLQ-C30 SubScale Score Social (Functional Scale): End of Treatment	63.1 score on a scale Standard Deviation 27.35	69.8 score on a scale Standard Deviation 24.76
HRQOL Based on EORTC QLQ-C30 SubScale Score Fatigue (Symptom Scale): Baseline	60.0 score on a scale Standard Deviation 22.89	61.0 score on a scale Standard Deviation 23.07
HRQOL Based on EORTC QLQ-C30 SubScale Score Fatigue (Symptom Scale): End of Treatment	50.8 score on a scale Standard Deviation 25.02	50.3 score on a scale Standard Deviation 25.77
HRQOL Based on EORTC QLQ-C30 SubScale Score Global Health Status/QoL: Baseline	57.0 score on a scale Standard Deviation 20.72	60.8 score on a scale Standard Deviation 21.16
HRQOL Based on EORTC QLQ-C30 SubScale Score Global Health Status/QoL: End of Treatment	47.8 score on a scale Standard Deviation 19.56	48.2 score on a scale Standard Deviation 19.61
HRQOL Based on EORTC QLQ-C30 SubScale Score Emotional (Functional Scale): Baseline	74.9 score on a scale Standard Deviation 21.19	83.1 score on a scale Standard Deviation 21.70
HRQOL Based on EORTC QLQ-C30 SubScale Score Nausea/Vomiting (Symptom Scale): Baseline	96.7 score on a scale Standard Deviation 8.41	94.8 score on a scale Standard Deviation 11.54
HRQOL Based on EORTC QLQ-C30 SubScale Score Nausea/Vomiting (Symptom Scale): End of Treatment	88.7 score on a scale Standard Deviation 15.75	92.9 score on a scale Standard Deviation 16.52
HRQOL Based on EORTC QLQ-C30 SubScale Score Pain (Symptom Scale): Baseline	61.1 score on a scale Standard Deviation 30.77	65.2 score on a scale Standard Deviation 24.70
HRQOL Based on EORTC QLQ-C30 SubScale Score Pain (Symptom Scale): End of Treatment	51.2 score on a scale Standard Deviation 26.42	53.2 score on a scale Standard Deviation 28.33
HRQOL Based on EORTC QLQ-C30 SubScale Score Dyspnea (Symptom Scale): Baseline	25.2 score on a scale Standard Deviation 28.56	19.0 score on a scale Standard Deviation 25.74
HRQOL Based on EORTC QLQ-C30 SubScale Score Dyspnea (Symptom Scale): End of Treatment	40.5 score on a scale Standard Deviation 30.57	24.6 score on a scale Standard Deviation 26.61
HRQOL Based on EORTC QLQ-C30 SubScale Score Insomnia (Symptom Scale): Baseline	32.6 score on a scale Standard Deviation 29.72	29.5 score on a scale Standard Deviation 31.87
HRQOL Based on EORTC QLQ-C30 SubScale Score Insomnia (Symptom Scale): End of Treatment	36.9 score on a scale Standard Deviation 34.35	29.4 score on a scale Standard Deviation 34.69
HRQOL Based on EORTC QLQ-C30 SubScale Score Appetite Loss (Symptom Scale): Baseline	22.2 score on a scale Standard Deviation 27.52	14.3 score on a scale Standard Deviation 22.39
HRQOL Based on EORTC QLQ-C30 SubScale Score Appetite Loss (Symptom Scale): End of Treatment	34.5 score on a scale Standard Deviation 34.52	23.0 score on a scale Standard Deviation 28.02
HRQOL Based on EORTC QLQ-C30 SubScale Score Constipation (Symptom Scale): Baseline	13.3 score on a scale Standard Deviation 23.99	11.4 score on a scale Standard Deviation 20.37
HRQOL Based on EORTC QLQ-C30 SubScale Score Constipation (Symptom Scale): End of Treatment	25.0 score on a scale Standard Deviation 34.69	19.8 score on a scale Standard Deviation 29.50
HRQOL Based on EORTC QLQ-C30 SubScale Score Diarrhea (Symptom Scale): Baseline	17.8 score on a scale Standard Deviation 23.14	16.7 score on a scale Standard Deviation 23.23
HRQOL Based on EORTC QLQ-C30 SubScale Score Diarrhea (Symptom Scale): End of Treatment	19.0 score on a scale Standard Deviation 26.34	16.3 score on a scale Standard Deviation 25.95
HRQOL Based on EORTC QLQ-C30 SubScale Score Financial Difficulties (Symptom Scale): Baseline	22.2 score on a scale Standard Deviation 27.52	17.1 score on a scale Standard Deviation 25.85
HRQOL Based on EORTC QLQ-C30 SubScale Score Financial Difficulties (Symptom Scale): End of Treatment	16.7 score on a scale Standard Deviation 21.28	12.7 score on a scale Standard Deviation 22.03

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)

Population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.

The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=45 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=70 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Body Image: Baseline	81.5 score on a scale Standard Deviation 23.09	82.9 score on a scale Standard Deviation 23.90
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Disease Symptoms: Baseline	73.2 score on a scale Standard Deviation 17.06	72.4 score on a scale Standard Deviation 21.31
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Disease Symptoms: End of Treatment	73.5 score on a scale Standard Deviation 17.75	68.9 score on a scale Standard Deviation 23.09
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Side Effects of Treatment: Baseline	81.0 score on a scale Standard Deviation 13.45	81.4 score on a scale Standard Deviation 13.30
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Side Effects of Treatment: End of Treatment	74.4 score on a scale Standard Deviation 17.84	77.8 score on a scale Standard Deviation 14.47
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Body Image: End of Treatment	75.0 score on a scale Standard Deviation 30.93	83.7 score on a scale Standard Deviation 23.71
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Future Perspective: Baseline	58.8 score on a scale Standard Deviation 23.29	67.5 score on a scale Standard Deviation 24.03
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score Future Perspective: End of Treatment	57.9 score on a scale Standard Deviation 28.26	64.0 score on a scale Standard Deviation 19.21

SECONDARY outcome

Timeframe: End of Treatment (Up to 28 cycles, each cycle was of 28 days)

Population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Overall number of participants analyzed are the number of participants with data available for analyses.

EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=27 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=41 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Mobility: 5 = I am Unable to Walk About	0 Participants	1 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Mobility: 1 = I Have no Problems in Walking About	5 Participants	9 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Mobility: 2 = I Have Slight Problems in Walking About	6 Participants	12 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Mobility: 3 = I Have Moderate Problems in Walking About	8 Participants	11 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Mobility: 4 = I Have Severe Problems in Walking About	8 Participants	8 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Self-Care: 1 = I Have no Problems Washing or Dressing Myself	13 Participants	21 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Self-Care: 2 = I Have Slight Problems Washing or Dressing Myself	6 Participants	10 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Self-Care: 3 = I Have Moderate Problems Washing or Dressing Myself	5 Participants	4 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Self-Care: 4 = I Have Severe Problems Washing or Dressing Myself	3 Participants	4 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Self-Care: 5 = I am Unable to Wash or Dress Myself	0 Participants	2 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Usual Activities: 1 = I Have no Problems Doing my Usual Activities	4 Participants	10 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Usual Activities: 2 = I Have Slight Problems Doing my Usual Activities	7 Participants	9 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Usual Activities: 3 = I Have Moderate Problems Doing my Usual Activities	8 Participants	12 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Usual Activities: 4 = I Have Severe Problems Doing my Usual Activities	7 Participants	7 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Usual Activities: 5 = I am Unable to do my Usual Activities	1 Participants	3 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Pain/Discomfort: 1 = I Have no Pain or Discomfort	3 Participants	8 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Pain/Discomfort: 2 = I Have Slight Pain or Discomfort	5 Participants	10 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Pain/Discomfort: 3 = I Have Moderate Pain or Discomfort	13 Participants	15 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Pain/Discomfort: 4 = I Have Severe Pain or Discomfort	6 Participants	6 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Pain/Discomfort: 5 = I Have Extreme Pain or Discomfort	0 Participants	2 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Anxiety/Depression: 1 = I Have no Pain or Discomfort	6 Participants	19 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Anxiety/Depression: 2 = I Have no Pain or Discomfort	8 Participants	13 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Anxiety/Depression: 3 = I Have no Pain or Discomfort	11 Participants	6 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Anxiety/Depression: 4 = I Have no Pain or Discomfort	2 Participants	1 Participants
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score Anxiety/Depression: 5 = I Have no Pain or Discomfort	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)

Population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.

The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life.

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=45 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=70 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score Baseline	59.2 score on a scale Standard Deviation 20.96	64.4 score on a scale Standard Deviation 18.21
HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score End of Treatment	46.9 score on a scale Standard Deviation 19.07	55.9 score on a scale Standard Deviation 19.60

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: ITT Population included all participants who were randomized.

Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter Hospitalizations	16 Participants	23 Participants
Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter Emergency Room Stays	9 Participants	11 Participants
Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter Outpatient Visits	29 Participants	32 Participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: ITT Population included all participants who were randomized.

Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).

Outcome measures

Outcome measures
Measure	Pomalidomide 4 mg + Dexamethasone 40 mg n=49 Participants Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.	Ixazomib 4 mg + Dexamethasone 20 mg n=73 Participants Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
HU: Duration of Medical Encounters Hospitalizations	2.0 days Interval 1.0 to 6.0	1.0 days Interval 1.0 to 10.0
HU: Duration of Medical Encounters Emergency Room Stays	1.0 days Interval 1.0 to 3.0	1.0 days Interval 1.0 to 3.0
HU: Duration of Medical Encounters Outpatient Visits	4.0 days Interval 1.0 to 57.0	3.0 days Interval 1.0 to 34.0

Adverse Events

Pomalidomide 4 mg + Dexamethasone 40 mg

Serious events: 26 serious events

Other events: 45 other events

Deaths: 17 deaths

Ixazomib 4 mg + Dexamethasone 20 mg

Serious events: 40 serious events

Other events: 62 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Publication restrictions are in place

Restriction type: OTHER