Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT)
CompletedPhase 3Results postedLast updated 21 March 2025
What this trial tests
Phase 3 trial testing Ixazomib in Multiple Myeloma in 37 participants. Completed in 6 December 2023.
18 and older, any sex, with 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.
Number of Participants Categorized According to Performance Status (PS) Based on Eastern Cooperative Oncology Group (ECOG) PSPrimary· Month 25
ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead.
ECOG Score 0
Group
Value
95% CI
Ixazomib
34
ECOG Score 1
Group
Value
95% CI
Ixazomib
1
Percentage of Participants Receiving Ixazomib With Treatment-emergent Adverse Events (TEAEs)Primary· Up to 58.4 months
Adverse events (AEs) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. Percentages are rounded off to the nearest whole number.
Group
Value
95% CI
Ixazomib
97
Percentage of Participants Receiving Ixazomib With Treatment-emergent Serious Adverse Events (SAEs)Primary· Up to 58.4 months
AEs were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disabili
Group
Value
95% CI
Ixazomib
31
Number of Participants Receiving Ixazomib With Clinically Significant Changes in Safety Laboratory ValuesPrimary· Up to 58.4 months
Clinical laboratory assessments included hematology, serum chemistry, and urinalysis. Any clinically significant changes in the clinical laboratory value over time based on the investigator's interpretation were reported.
Group
Value
95% CI
Ixazomib
0
Progression-Free Survival (PFS)Secondary· From the first dose of study drug to every 4 weeks until PD or death from any cause (up to 58.4 months)
PFS was defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10 milligrams per deciliter \[mg/dL\]); bone marrow plasma cell percent ≥10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia
Group
Value
95% CI
Ixazomib
21.3
9.20 – NA
Overall Survival (OS)Secondary· From the first dose of study drug to every 12 weeks during follow-up after PD or next line therapy or death whichever occurred later (up to 58.4 months)
OS was measured as the time from the date of first dose of study drug to the date of death.
Group
Value
95% CI
Ixazomib
NA
NA – NA
Percentage of Participants Who Achieved or Maintained Best Response Before PD or up to Subsequent TherapySecondary· Up to 58.4 months
Response was assessed according to International Myeloma Working Group (IMWG) criteria. Best response includes partial response (PR), very good partial response (VGPR), and complete response (CR). PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to less than (\<)200 mg per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft
PR
Group
Value
95% CI
Ixazomib
3
VGPR
Group
Value
95% CI
Ixazomib
12
CR
Group
Value
95% CI
Ixazomib
76
Duration of Complete Response (CR)Secondary· Up to 58.4 months
Duration of CR was defined as the time from the date of first dose of study drug or the date of CR to the date of first documentation of PD. CR was defined as negative immunofixation on the serum and urine; soft tissue plasmacytomas disappearance; \<5% plasma cells (PCs) in bone marrow.
Group
Value
95% CI
Ixazomib
NA
12.88 – NA
Time to Progression (TTP)Secondary· Up to 58.4 months
TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD. PD was defined as ≥25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL); bone marrow plasma cell percent ≥10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Group
Value
95% CI
Ixazomib
21.3
9.20 – NA
Time to Next-Line Therapy (TTNT)Secondary· Up to 58.4 months
TTNT was defined as the time from the date of first dose of study drug to the date of the first dose of next-line of antineoplastic therapy.
Group
Value
95% CI
Ixazomib
NA
24.48 – NA
Percentage of Participants With A New Primary MalignancySecondary· Up to 58.4 months
Group
Value
95% CI
Ixazomib
0
Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 as Measured by the Global Health Status (GHS)Secondary· Baseline, Cycle 26 (cycle length=28 days)
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.
Group
Value
95% CI
Ixazomib
-5.3
± 15.49
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 58.4 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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 Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· 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: 21 March 2025
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/NCT03748953.