18 and older, any sex, with Hematopoietic Cell Transplantation Recipient or Plasma Cell 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 SurvivalPrimary· Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatment
Monitored using the method of Thall et al. Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
73.3
59.9 – NA
Best Response Rate (Stringent Complete Response [sCR]/Near Complete Response [nCR]/Very Good Partial Response [VGPR]/Partial Response [PR])Secondary· through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Estimated along with 95% confidence intervals.
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
98.4
91.5 – 100
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic EffectsSecondary· throughout study treatment and up to 30 days after completion of study treatment, up to 119 months
Toxicity data will be summarized by frequency tables.
Serious AE-Lung Infections
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
12
Serious AE-Treatment-related secondary malignancy
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
9
Serious AE-Respiratory Disorders including respiratory failures
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
8
Serious AE-other infections
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
5
Number of Participants Incidence of New Primary MalignancySecondary· through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Count of participants
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
9
Overall SurvivalSecondary· through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Estimated using the Kaplan-Meier method. Cox proportional hazards model will be used to include multiple covariates. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
NA
NA – NA
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom EvaluationSecondary· through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Analyzed with descriptive analysis. The MDASI-MM scores measure the how severe the symptoms are, so higher scores are considered to be worse patient outcomes. Five subscales are derived from the 26 questions of the MDASI-MM questionnaire:
1. mean core (13 MDASI core symptom items), ranges from 0 to 130.
2. mean severity (13 MDASI core plus 7 MM-specific items), ranges from 0 to 200.
3. mean interference (6 interference items), ranges from 0 to 60.
4. mean WAW (interference with work, general activity, and walking), ranges from 0 to 30.
5. mean REM (interference with relations with people, enj
Core Score at Cycle 1
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
1.13
± 1.35
Severity Score at Cycle 1
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
1.01
± 1.27
Interference Score at Cycle 1
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
0.97
± 1.52
WAW Score at Cycle 1
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
1.12
± 1.67
REM Score at Cycle 1
Group
Value
95% CI
Treatment (Ixazomib Citrate, Lenalidomide)
0.81
± 1.54
Adverse events — posted to ClinicalTrials.gov
Time frame: through out study treatment and up to 30 days after completion of study treatment, up to 119 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Ixazomib Citrate, Lenalidomide)
Serious: 33/64 (52%)
Deaths: 0/64
Serious adverse events (19 terms)
Reaction
System
Treatment (Ixazomib Citrat…
Lung infection
Respiratory, thoracic and mediastinal disorders
—
Treatment-related secondary malignancy
General disorders
—
Respiratory, thoracic, and mediastinal disorders, including respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Infections and infestations
Infections and infestations
—
Sepsis
General disorders
—
Neoplasms benign, malignant, and unspecified (inclcysts and ployps)
Blood and lymphatic system disorders
—
Upper respiratory infection
Respiratory, thoracic and mediastinal disorders
—
Acute kidney inury
Renal and urinary disorders
—
Dehydration
General disorders
—
Pancreatitis
Gastrointestinal disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Urinary tract infection
Infections and infestations
—
Urinary retention
Renal and urinary disorders
—
Fever
General disorders
—
Diarrhea
Gastrointestinal disorders
—
Thromboembolic event
Blood and lymphatic system disorders
—
Nervous system disorders
Nervous system disorders
—
Non-cardiac chest pain
General disorders
—
Syncope
General disorders
—
Other adverse events (174 terms — click to expand)
This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04305691 — Trial of Ixazomib for Kaposi Sarcoma
· Phase 2
· recruiting
NCT04847453 — Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloid
· Phase 1
· recruiting
NCT03941860 — Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM
· Phase 3
· completed
NCT03770260 — Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment
· Phase 1
· completed
NCT04047797 — Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
· Phase 2
· terminated
Other recruiting trials for Hematopoietic Cell Transplantation Recipient
Currently open trials in the same condition.
NCT02420860 — Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
· Phase 2
· active not recruiting
NCT00736749 — Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
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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 M.D. Anderson Cancer Center
Last refreshed: 28 January 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/NCT01718743.