Ninlaro (ixazomib)
/ Takeda
- LARVOL DELTA
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August 23, 2026
Discontinuation of Maintenance Therapy Guided by Minimal Residual Disease in Newly Diagnosed Multiple Myeloma: Long-Term Results of the GEM2014MAIN Study
(IMS 2026)
- " The GEM2014MAIN clinical trial randomly assigned lenalidomide and dexamethasone (RD) vs. ixazomib plus RD (IRD) as maintenance therapy in patients who received 6-cycles of induction therapy with bortezomib, lenalidomide and dexamethasone (VRD), followed by high-doses of melphalan or busulfan/melphalan and 2 consolidation cycles with VRD (GEM2012MENOS65 trial). Patients with MRDneg after two years of maintenance discontinued therapy and showed a significantly longer PFS than those with positive MRD that remained on maintenance. About half of the patients who were MRDneg at 2 years and discontinued maintenance remained alive and progression-free after 7 years and could be considered operationally cured."
Clinical • Minimal residual disease • Residual disease • Hematological Malignancies • Multiple Myeloma
September 11, 2026
Ixazomib, pomalidomide and dexamethasone in triple-class exposed multiple myeloma patients - a phase II study.
(PubMed, Haematologica)
- P2 | "Refractoriness rates to bortezomib, lenalidomide and daratumumab were 51%, 85% and 96% respectively. To conclude, the all-oral IPd regimen for TCE RRMM patients showed high response rates and a manageable safety profile, in a cohort enriched with TCR, elderly and frail patients. (NCT04790474)."
Clinical • Journal • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology
April 27, 2023
Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment.
(ASCO 2023)
- P1b/2, P2b, P3 | " We analyzed the effectiveness of non-cellular αBCMA (NCA) therapies in pts with MM treated in 4 clinical studies (STORM [NCT02336815]; STOMP [NCT02343042]; BOSTON [NCT03110562], XPORT-MM-028 [NCT04414475]) with selinexor + dexamethasone (Xd), with or without PIs, IMiDs, or αCD38 mAbs, followed by therapy with NCA...Thirty-seven pts (median age: 68, range: 40-87) received NCA therapy at any time following a selinexor regimen (Xd, n = 12; Xd + bortezomib, n = 9; Xd + pomalidomide, n = 6; Xd + daratumumab, n = 3; Xd + carfilzomib, n = 5; Xd + ixazomib, n = 2). NCAs included the ADC belantamab mafodotin (n = 28), the BiS teclistamab (n = 2), SEA-BCMA (n = 2), AMG 701 (n = 1), elranatamab (n = 1), MEDI2228 (n = 1), and investigational (n = 3; 2 had αBCMA bispecific antibodies and 1 had αBCMA BITE) (1 pt received 2 NCAs, belantamab and teclistamab)... In this cohort of heavily-pretreated pts with MM who received a selinexor regimen prior to NCA, overall..."
Hematological Malignancies • Immune Modulation • Multiple Myeloma • Oncology
September 25, 2026
A Multicenter Retrospective Comparative Analysis of Therapeutic Outcomes in Multiple Myeloma Patients Receiving Varied Ixazomib Dosage Regimens.
(PubMed, Cancer Med)
- "These findings suggest that initiating therapy with 3 mg ixazomib is both clinically viable and effective, potentially alleviating the economic burden for MM patients."
Clinical • Journal • Retrospective data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology
September 25, 2026
Preclinical evaluation of ixazomib for high-risk pediatric brain tumors.
(PubMed, bioRxiv)
- "While many pediatric brain tumor models demonstrate susceptibility to proteasome inhibition, ixazomib may lack sufficient blood-brain barrier penetration to be a translationally viable means of exploiting this vulnerability."
Journal • Preclinical • Brain Cancer • Diffuse Midline Glioma • Glioblastoma • Glioma • Medulloblastoma • Oncology • Pediatrics • Rhabdoid Tumor • Sarcoma • Solid Tumor • MYC
September 11, 2026
Severe Neuropathy Following Unintentional Ixazomib Overdose in Multiple Myeloma: A Case Report and Review of the Literature
(IMS 2026)
- " n/a An 85-year-old man with relapsed multiple myeloma was started on ixazomib, lenalidomide, and dexamethasone (IRd). Ixazomib overdose can result in substantial morbidity and mortality. Our case is the first reported case of severe, prolonged autonomic neuropathy following ixazomib overdose. Across all reported cases, the most severe toxicities occurred in patients who ingested the entire dose on a single day rather than over multiple days."
Case report • Clinical • Review • Acute Respiratory Distress Syndrome • Cardiovascular • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma • Peripheral Neuropathic Pain • Respiratory Diseases • Thrombocytopenia
September 11, 2026
Real-World Outcomes Following Second Line Treatment for Multiple Myeloma in Wales
(IMS 2026)
- "We categorised patients into six groups according to the second line regimen received: Daratumumab, Bortezomib and Dexamethasone (DVd), Carfilzomib, Lenalidomide and Dexamethasone (KRd), Ixazomib, Lenalidomide and Dexamethasone (IRd), Autologous stem cell transplant (Auto), Lenalidomide and Dexamethasone (Rd) and other Proteasome Inhibitor (PI)-based therapies (Other)...In 2025, the UK approved the anti-BCMA, antibody drug conjugate Belantamab Mafodotin, in combination with both Bortezomib and Dexamethasone (BVd) and Pomalidomide and Dexamethasone (BPd) for use at second line. In this real-world analysis of prescribing practice in Wales, our data shows that patients treated with DVd at second line achieved a superior 12mPFS, when compared to other triplet therapies. It also demonstrated an excellent 12mPFS for patients receiving an autologous stem cell transplant at second line. The data confirms the superior outcomes seen in patients with ISS I+II disease at diagnosis;..."
Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma
September 11, 2026
Longitudinal Single-Cell Profiling Reveals Reproducible Clonal Expansion of Cytotoxic CD8? TEMRA Cells Following Daratumumab-Based Therapy
(IMS 2026)
- P1/2 | "MyDRUG patients received daratumumab, ixazomib, pomalidomide, and dexamethasone (D-IPd), with samples collected after 2 cycles, 4 cycles, and at end of treatment or progression. These data provide a longitudinal, high-resolution view of the immune microenvironment in functional high-risk myeloma during D-IPd therapy and identify early treatment-associated remodeling of immune compartments. Across cohorts, daratumumab-based therapy was associated with expansion of clonally proliferative, cytotoxic T EMRA cells, supporting enhanced antigen-driven CD8 T-cell responses in the myeloma microenvironment. These findings support rational combinations of targeted and immune therapies to improve efficacy."
IO biomarker • Hematological Malignancies • Multiple Myeloma • B3GAT1 • CD8 • GZMB • GZMH • ITGAX • NKG7
September 11, 2026
Ixazomib, Lenalidomide, Dexamethasone Treatment with Cytogenetic Risk-Based Maintenance in Transplant-Eligible Multiple Myeloma Patients: The Expanded Results of a Phase 2 Study
(IMS 2026)
- "After a longer follow-up HR patients have still equal PFS with NHR patients when getting double maintenance. Mass spectrometry analyses are ongoing; however, preliminary data indicate that patients achieving triple negativity demonstrate the most favorable outcomes, with no observed progression. 1 Flores-Montero J, Sanoja-Flores L, Paiva B, Puig N, Garcia-Sanchez O, Bottcher S, et al."
Clinical • P2 data • Hematological Malignancies • Leukemia • Multiple Myeloma • Transplantation
September 11, 2026
Immune Recovery and Infectious Events with Ixazomib Versus Anti-Cd38 Maintenance in Mrd-Negative Transplant-Ineligible NDMM
(IMS 2026)
- " The anti-CD38 antibody group comprised isatuximab (n=10) and daratumumab (n=5). In MRD-negative transplant-ineligible NDMM patients who maintained disease control during maintenance therapy, IXZ was associated with greater endogenous IgG recovery and fewer infection-related episodes than anti-CD38 antibody maintenance. These findings suggest recovery of host immune function after induction therapy during IXZ maintenance. IXZ may be a useful option for elderly or frail patients in whom infection prevention and immune preservation are important, and may offer clinical and potential health-economic advantages in the maintenance setting."
Clinical • Minimal residual disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Geriatric Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Musculoskeletal Pain • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation
September 11, 2026
Elevated APOBEC3B Expression Marks Functionally High-Risk Multiple Myeloma with Early Failure of Frontline Pi/Imid Therapy
(IMS 2026)
- " RNA-sequencing data from the CoMMpass cohort were analyzed in newly diagnosed MM patients treated with frontline PI/IMiD-based regimens, including bortezomib-, carfilzomib-, or ixazomib-based therapies combined with lenalidomide- or thalidomide-containing backbones, with or without ASCT. Elevated A3B expression defines a biologically aggressive, clinically high-risk MM subset associated with early failure of frontline PI/IMiD-based therapy and inferior survival. Convergent transcriptomic and functional analyses identify A3B as a clinically relevant biomarker linked to replication stress and chromosomal instability programs associated with early therapeutic failure in MM, warranting further evaluation in the anti-CD38 era."
IO biomarker • Hematological Malignancies • Multiple Myeloma • APOBEC3B • CHEK1 • RPA2
September 11, 2026
Efficacy and Safety of Ixazomib-Based Versus Bortezomib/Lenalidomide-Based Maintenance After Autologous Stem Cell Transplantation for Multiple Myeloma: A Multi-Center Retrospective Real-World Study
(IMS 2026)
- "Ixazomib-based regimens comprised ixazomib monotherapy (I, 3 or 4 mg orally on days 1, 8, 15 of 28-day cycles), ixazomib plus lenalidomide (IR, R 10-25 mg orally on days 1-14 or 1-21), or ixazomib plus pomalidomide (IP, P 2 or 4 mg orally on days 1-14 or 1-21). In this real-world study, ixazomib-based maintenance significantly improved PFS/OS after ASCT in NDMM, including high-risk patients, with lower toxicity and fewer discontinuations (2.97% vs. 19.80%). These findings support ixazomib-based maintenance as an effective, well-tolerated strategy."
Real-world • Real-world evidence • Retrospective data • Hematological Malignancies • Multiple Myeloma • Transplantation
September 11, 2026
Functional Precision Medicine Using Ex Vivo Drug Sensitivity Profiling to Guide Therapy Selection in Relapsed/Refractory Multiple Myeloma: Results of a Prospective Clinical Trial
(IMS 2026)
- P=N/A | "Prior exposure included lenalidomide (100%), bortezomib (97.5%), carfilzomib (85%), daratumumab (82%), pomalidomide (77.5%), and BCMA CAR-T (12.5%). Top-ranked agents by DSS in v1 included bortezomib (median DSS 47.7), carfilzomib (47.3), panobinostat (47.0), and romidepsin (45.4). In v2, leading agents were marizomib ( 46.1), carfilzomib (40.2), ixazomib (37.2), and oprozomib (31.6)...ROC analysis for bortezomib (n=12) and selinexor (n=8) yielded AUCs of 0.471 and 0.462, respectively... High-throughput drug sensitivity testing was feasible in heavily pretreated RRMM and generated actionable results in nearly all patients. DSS-based prediction varied across agents, highlighting the need for drug-specific thresholds and larger validation cohorts. These findings support further development of functional precision medicine as a complementary tool to refine therapeutic decision-making in RRMM"
Late-breaking abstract • Preclinical • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia • Plasmacytoma • SDC1
September 04, 2026
A Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single autologous stem cell transplantation as part of front-line therapy
(ANZCTR)
- P3 | N=310 | Completed | Sponsor: Australasian Leukaemia and Lymphoma Group (ALLG) | Active, not recruiting ➔ Completed
Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34
August 05, 2026
Ex Vivo Drug Screening Captures Heterogeneous Sensitivity to Proteasome Inhibition in WHO 2021-Defined Glioblastoma and Reveals Molecular and Survival Correlates
(EANO 2026)
- "Cells were treated with Carfilzomib and Ixazomib across a concentration range (20µM - 4,5nM), and drug response was quantified as the area under the dose-response curve (AUC). Ex vivo drug screening reveals significant variability in glioblastoma response to proteasome inhibition, supporting biomarker-driven patient stratification. MGMT promoter methylation and EGFR amplification do not predict sensitivity, but tumor type does—recurrent tumors are less responsive to Carfilzomib than primary tumors. These results emphasize the potential of functional precision oncology to improve stratification beyond traditional molecular markers, though further research is needed to clarify underlying mechanisms."
Heterogeneity • Preclinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • EGFR • MGMT
November 17, 2024
Ixazomib, pomalidomide and dexamethasone in relapsed or refractory multiple myeloma characterized with high-risk cytogenetics: the IFM 2014-01 study.
(PubMed, Haematologica)
- "Not available."
Journal • Hematological Malignancies • Multiple Myeloma • Oncology
November 03, 2023
Gain1q in Myeloma Randomized Clinical Trials- How Is It Reported and How Does It Impact Outcomes: A Systematic Review
(ASH 2023)
- "Amongst trials that met primary endpoint showing improvement in PFS and clearly reported on +1q, the following drugs also improved PFS for those with +1q (when comparing hazard ratio (HR) for intervention versus control arm in the +1q subgroup): lenalidomide (len) maintenance in Myeloma XI, selinexor in BOSTON, and isatuximab in IKEMA and ICARIA...These included addition of carfilzomib in Myeloma XI, addition of carfilzomib vs bortezomib to len and dex for +1q (but not in Amp1q) in ENDURANCE, addition of elotuzumab to pomalidomide and dex, and bortezomib-based treatment before and after autologous stem cell transplantation (auto-SCT) vs no bortezomib (Table 2)...Important interventions for which subgroup analysis of +1q was not presented in trial results, and hence conclusions about the efficacy of the drugs specifically for patients with +1q cannot be ascertained included pomalidomide and ixazomib. Although subgroup analysis of various daratumumab trials has shown..."
Clinical • Review • Hematological Malignancies • Multiple Myeloma • Oncology
September 21, 2022
Ixazomib, lenalidomide and dexamethasone consolidation with randomized ixazomib or lenalidomide maintenance after autologous transplant in newly diagnosed multiple myeloma.
(PubMed, Leukemia)
- No abstract available
Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation
January 12, 2023
A pooled analysis of outcomes according to cytogenetic abnormalities in patients receiving ixazomib- vs placebo-based therapy for multiple myeloma.
(PubMed, Blood Cancer J)
- "We evaluated 2247 MM patients from the TOURMALINE-MM1/-MM2/-MM3/-MM4 trials to assess the PFS benefit of ixazomib plus lenalidomide-dexamethasone (Rd) vs placebo-Rd (TOURMALINE-MM1/-MM2) or ixazomib vs placebo (TOURMALINE-MM3/-MM4) in specific high-risk CAs. The HR for PFS with ixazomib- vs placebo-based therapy was 0.68 in patients with t(4;14) (95% CI: 0.48-0.96; mPFS 22.4 vs 13.2 months), and 0.77 for patients with amp1q21 (95% CI: 0.63-0.93; mPFS 18.8 vs 14.5 months). A PFS benefit was demonstrated with ixazomib- vs placebo-based therapy regardless of cytogenetic status, with greatest benefit observed in patients with t(4;14) and amp1q21."
Journal • Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology
August 22, 2025
A Randomized Phase 2 Study of Daratumumab, Lenalidomide, Ixazomib, and Dexamethasone in Transplant-Ineligible/Deferred Patients with Newly Diagnosed Multiple Myeloma: Alliance Foundation Trial 41
(IMS 2025)
- P2 | "Dara-RId offers a regimen that has the efficacy of a 4 drug combination with the convenience of oral ixazomib and minimizes the risk of peripheral neuropathy for older, transplant ineligible NDMM. There is ongoing follow up to determine the benefit of maintenance with dara RI v. R alone. Support: AFT, Celgene, Janssen, Takeda"
Clinical • P2 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation
January 08, 2022
Safety and Efficacy of Combination Maintenance Therapy with Ixazomib and Lenalidomide in Post-transplant Myeloma Patients.
(PubMed, Clin Cancer Res)
- "The addition of ixazomib to lenalidomide maintenance demonstrated a better than expected PFS compared with historical data using lenalidomide alone and was safe and tolerable."
Clinical • Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Pain • Respiratory Diseases • Thrombocytopenia • Transplantation
November 05, 2021
Ixazomib Plus Lenalidomide/Dexamethasone (IRd) Versus Lenalidomide /Dexamethasone (Rd) Maintenance after Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Results of the Spanish GEM2014MAIN Trial
(ASH 2021)
- "Background: The Spanish Myeloma Group (GEM) demonstrated that post-transplant maintenance with thalidomide plus bortezomib was superior to thalidomide alone, although this combination was associated with a high rate of peripheral neuropathy...Patients : Patients who where at least with stable disease after the GEM2012menos65 trial that included VRD-GEM induction, autologous hematopoietic stem cell transplantation conditioned with either melphalan-200 or intravenous busulfan together with melphalan-140 and consolidation with VRD-GEM were randomized to receive maintenance treatment with IRd versus Rd... After a median follow-up of 56 months, there was no difference in PFS between the two maintenance arms (median not reached, PFS at 5 years: 62% vs. 63% with IRd and Rd, respectively, p=0.785) (figure 1). In the overall series, there were no significant differences in PFS or OS among patients with standard (SR) or high-risk (HR) cytogenetics."
Clinical • Bone Marrow Transplantation • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Pain • Plasmacytoma • Thrombocytopenia • Transplantation
September 01, 2026
A Case of a Patient With Multiple Myeloma and Concurrent Aspergillosis Infection
(SOHO 2026)
- "He had a history of MM for 8 years; complete remission (CR) was achieved after treatments with bortezomib, cyclophosphamide, and dexamethasone (VCD) and ixazomib, lenalidomide, and dexamethasone (IRd) during this period...The patient was in good condition after treatment with carfilzomib, daratumumab, and dexamethasone (DKd) for MM and isavuconazole for aspergillosis... MM is a malignant disease characterized by abnormal proliferation of cloned plasma cells. Induction therapy is mainly based on a three-drug combination regimen of proteasome inhibitors, immunomodulators, and dexamethasone. Auto-HSCT should be performed after remission."
Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • CD20 • IRF4 • LXN • NCAM1 • PAX5 • SDC1
April 25, 2024
All-oral triplet iberdomide, ixazomib, and dexamethasone in elderly patients with multiple myeloma at first relapse: Results of the IFM phase 2 study I2D.
(ASCO 2024)
- P2 | "Background: The triplet combination daratumumab, lenalidomide and dexamethasone (DRd) and bortezomib, lenalidomide and dexamethasone (VRd) are to date the standard of care for patients with transplant ineligible (TI) newly diagnosed multiple myeloma (MM)...Iberdomide is a novel oral cereblon E3 ligase modulator (CELMoD) that demonstrated promising activity in MM patients refractory to lenalidomide/pomalidomide... The oral tripletiberdomide, ixazomib and dexamethasone demonstrated a favorable efficacy / safety profile in elderly MM patients at first relapse, including in patients with lenalidomide and daratumumab refractory disease."
Clinical • P2 data • Dermatology • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Pain • Targeted Protein Degradation • Thrombocytopenia • CRBN
March 07, 2025
Zanubrutinib plus Ixazomib and Dexamethasone in newly diagnosed symptomatic Waldenström macroglobulinemia:a phase II study.
(PubMed, Clin Cancer Res)
- P2 | "ZID regimen might offer deep remission and provided a time-limited BTKi therarpy in WM patients. ."
Journal • P2 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Oncology • Waldenstrom Macroglobulinemia • CXCR4
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