18 and older, any sex, with Relapsed and/or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· 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)
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 w
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
4.8
3.745 – 8.542
Ixazomib 4 mg + Dexamethasone 20 mg
7.1
3.943 – 11.138
Overall Survival (OS)Secondary· From date of randomization to death due to any cause (Up to approximately 3 years)
OS was defined as the time from randomization to death from any cause, up to 3 years are reported.
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
NA
13.963 – NA
Ixazomib 4 mg + Dexamethasone 20 mg
18.8
10.973 – NA
Percentage of Participants With Overall ResponseSecondary· From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
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 b
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
41
27 – 56
Ixazomib 4 mg + Dexamethasone 20 mg
38
27 – 50
Duration of Response (DOR)Secondary· 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)
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
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
14.3
3.713 – NA
Ixazomib 4 mg + Dexamethasone 20 mg
14.8
10.152 – 19.614
Time to ResponseSecondary· From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
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 immun
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
1.1
0.953 – 2.037
Ixazomib 4 mg + Dexamethasone 20 mg
2.0
1.906 – 2.858
Time to Progression (TTP)Secondary· 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)
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
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
5.1
3.844 – 12.485
Ixazomib 4 mg + Dexamethasone 20 mg
8.4
5.684 – 13.306
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 ScoreSecondary· Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
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.
Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
67.0
± 21.97
Ixazomib 4 mg + Dexamethasone 20 mg
67.9
± 22.08
End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
52.4
± 28.03
Ixazomib 4 mg + Dexamethasone 20 mg
56.5
± 26.10
HRQOL Based on EORTC QLQ-C30 SubScale ScoreSecondary· Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
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
Global Health Status/QoL: Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
57.0
± 20.72
Ixazomib 4 mg + Dexamethasone 20 mg
60.8
± 21.16
Global Health Status/QoL: End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
47.8
± 19.56
Ixazomib 4 mg + Dexamethasone 20 mg
48.2
± 19.61
Role (Functional Scale): Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
67.4
± 28.42
Ixazomib 4 mg + Dexamethasone 20 mg
67.9
± 29.67
Role (Functional Scale): End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
47.6
± 27.86
Ixazomib 4 mg + Dexamethasone 20 mg
49.2
± 27.04
Emotional (Functional Scale): Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
74.9
± 21.19
Ixazomib 4 mg + Dexamethasone 20 mg
83.1
± 21.70
Emotional (Functional Scale): End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
67.6
± 25.19
Ixazomib 4 mg + Dexamethasone 20 mg
72.8
± 22.62
Cognitive(Functional Scale): Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
79.6
± 20.38
Ixazomib 4 mg + Dexamethasone 20 mg
84.0
± 20.74
Cognitive (Functional Scale): End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
69.6
± 27.61
Ixazomib 4 mg + Dexamethasone 20 mg
77.4
± 22.64
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) ScoreSecondary· Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
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.
Disease Symptoms: Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
73.2
± 17.06
Ixazomib 4 mg + Dexamethasone 20 mg
72.4
± 21.31
Disease Symptoms: End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
73.5
± 17.75
Ixazomib 4 mg + Dexamethasone 20 mg
68.9
± 23.09
Side Effects of Treatment: Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
81.0
± 13.45
Ixazomib 4 mg + Dexamethasone 20 mg
81.4
± 13.30
Side Effects of Treatment: End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
74.4
± 17.84
Ixazomib 4 mg + Dexamethasone 20 mg
77.8
± 14.47
Body Image: Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
81.5
± 23.09
Ixazomib 4 mg + Dexamethasone 20 mg
82.9
± 23.90
Body Image: End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
75.0
± 30.93
Ixazomib 4 mg + Dexamethasone 20 mg
83.7
± 23.71
Future Perspective: Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
58.8
± 23.29
Ixazomib 4 mg + Dexamethasone 20 mg
67.5
± 24.03
Future Perspective: End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
57.9
± 28.26
Ixazomib 4 mg + Dexamethasone 20 mg
64.0
± 19.21
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) ScoreSecondary· End of Treatment (Up to 28 cycles, each cycle was of 28 days)
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.
Mobility: 1 = I Have no Problems in Walking About
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
5
Ixazomib 4 mg + Dexamethasone 20 mg
9
Mobility: 2 = I Have Slight Problems in Walking About
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Ixazomib 4 mg + Dexamethasone 20 mg
12
Mobility: 3 = I Have Moderate Problems in Walking About
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Ixazomib 4 mg + Dexamethasone 20 mg
11
Mobility: 4 = I Have Severe Problems in Walking About
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Ixazomib 4 mg + Dexamethasone 20 mg
8
Mobility: 5 = I am Unable to Walk About
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
0
Ixazomib 4 mg + Dexamethasone 20 mg
1
Self-Care: 1 = I Have no Problems Washing or Dressing Myself
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
13
Ixazomib 4 mg + Dexamethasone 20 mg
21
Self-Care: 2 = I Have Slight Problems Washing or Dressing Myself
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Ixazomib 4 mg + Dexamethasone 20 mg
10
Self-Care: 3 = I Have Moderate Problems Washing or Dressing Myself
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
5
Ixazomib 4 mg + Dexamethasone 20 mg
4
HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) ScoreSecondary· Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
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.
Baseline
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
59.2
± 20.96
Ixazomib 4 mg + Dexamethasone 20 mg
64.4
± 18.21
End of Treatment
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
46.9
± 19.07
Ixazomib 4 mg + Dexamethasone 20 mg
55.9
± 19.60
Health Care Utilization (HU): Number of Participants With at Least One Medical EncounterSecondary· Up to approximately 3 years
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).
Hospitalizations
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
16
Ixazomib 4 mg + Dexamethasone 20 mg
23
Emergency Room Stays
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
9
Ixazomib 4 mg + Dexamethasone 20 mg
11
Outpatient Visits
Group
Value
95% CI
Pomalidomide 4 mg + Dexamethasone 40 mg
29
Ixazomib 4 mg + Dexamethasone 20 mg
32
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing of the informed consent up to 30 days after last dose of the study drug (Up to approximately 4 years 3 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pomalidomide 4 mg + Dexamethasone 40 mg
Serious: 26/47 (55%)
Deaths: 17/49
Ixazomib 4 mg + Dexamethasone 20 mg
Serious: 40/72 (56%)
Deaths: 29/73
Serious adverse events (75 terms)
Reaction
System
Pomalidomide 4 mg + Dexame…
Ixazomib 4 mg + Dexamethas…
Pneumonia
Infections and infestations
—
—
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.
At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.
* Ixazomib capsules, given with dexamethasone tablets
* Pomalidomide capsules, given with dexamethasone tablets
All participants will take their study medicine on specific days during a 28-day cycle.
The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.
After treatment, participants will visit the clinic every 12 weeks for a check-up.
If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05722405 — Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
· Phase 4
· recruiting
NCT05183139 — A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide an
· Phase 4
· withdrawn
NCT04998786 — A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myel
· Phase 2
· active not recruiting
NCT04837131 — A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients
· Phase 2
· terminated
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob
· Phase 1
· withdrawn
Other recruiting trials for Relapsed and/or Refractory Multiple Myeloma
Currently open trials in the same condition.
NCT06153251 — A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT06182696 — OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
· Phase 1, PHASE2
· recruiting
NCT03715478 — Multi-Center Study of GSK2857916 in Combination With Pomalidomide and Dex
· Phase 1, PHASE2
· active not recruiting
Other Millennium Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob
· Phase 1
· withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati
· Phase 1
· completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab
· Phase 1
· completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
· Phase 1
· completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 20 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03170882.