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    DRUG:

    Ninlaro (ixazomib)

    i
    Other names: MLN 9708, MLN-2238, MLN2238, MLN-9708, MLN9708, MLN 2238
    Company:
    Takeda
    Drug class:
    Proteasome inhibitor
    Related drugs:
    21h
    NCI-2018-02830: Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
    3d
    Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P2, N=3, Active, not recruiting, M.D. Anderson Cancer Center | N=24 --> 3 | Trial completion date: Jun 2024 --> Dec 2025
    Enrollment change • Trial completion date
    |
    Rituxan (rituximab) • Ninlaro (ixazomib) • Truxima (rituximab-abbs)
    28d
    SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis (clinicaltrials.gov)
    P1, N=72, Recruiting, Queen Mary University of London | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    NCAM1 (Neural cell adhesion molecule 1) • SDC1 (Syndecan 1) • CD27 (CD27 Molecule) • NEFH (Neurofilament Heavy) • GFAP (Glial Fibrillary Acidic Protein) • NEFL (Neurofilament Light Chain) • S100B (S100 Calcium Binding Protein B)
    |
    Ninlaro (ixazomib)
    30d
    Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Kathleen Dorritie | N=34 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Ninlaro (ixazomib) • dexamethasone • mezigdomide (CC-92480)
    1m
    Discovery of Novel SIRT3 Inhibitors for the Cancer Differentiation Therapy by Structural Modification. (PubMed, Drug Dev Res)
    Additionally, molecule A7 reversed growth factor IL-6 induced MM cell proliferation, improved the antiproliferative activity of Ixazomib and increased the apoptotic rate of MM cells treated with Ixazomib. Collectively, potent SIRT3 inhibitors with MM cell differentiation potency were developed for the cancer therapy used alone or in combination.
    Journal
    |
    IL6 (Interleukin 6) • SIRT3 (Sirtuin 3) • ITGA5 (Integrin Subunit Alpha 5)
    |
    Ninlaro (ixazomib)
    2ms
    Efficacy and Safety of Ixazomib Combined with Thalidomide and Dexamethasone in Treatment of Multiple Myeloma (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi)
    Ixazomib combined with thalidomide and dexamethasone is effective in the treatment of MM, with good short-term efficacy, survival and safety. However, its long-term efficacy needs further observation.
    Retrospective data • Journal
    |
    B2M (Beta-2-microglobulin)
    |
    Ninlaro (ixazomib) • dexamethasone • thalidomide
    2ms
    Tasquinimod for the Treatment of Relapsed or Refractory Myeloma (clinicaltrials.gov)
    P1, N=34, Recruiting, University of Pennsylvania | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • Ninlaro (ixazomib) • dexamethasone • tasquinimod (ABR-215050)
    3ms
    Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara (clinicaltrials.gov)
    P2, N=401, Active, not recruiting, Stichting European Myeloma Network | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: May 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    bortezomib • cyclophosphamide • Ninlaro (ixazomib) • Darzalex (daratumumab) • thalidomide • melphalan
    3ms
    Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma (clinicaltrials.gov)
    P2, N=236, Active, not recruiting, Washington University School of Medicine | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date
    |
    lenalidomide • Ninlaro (ixazomib)
    3ms
    A Study of NINLARO® in Chinese Adults With Multiple Myeloma (clinicaltrials.gov)
    P=N/A, N=160, Recruiting, Takeda | N=320 --> 160 | Trial completion date: Oct 2025 --> Jun 2027 | Trial primary completion date: Oct 2025 --> Jun 2027
    Enrollment change • Trial completion date • Trial primary completion date • Real-world evidence • Real-world
    |
    bortezomib • Ninlaro (ixazomib) • carfilzomib
    3ms
    STOMP: Selinexor and Backbone Treatments of Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=300, Recruiting, Karyopharm Therapeutics Inc | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    lenalidomide • bortezomib • Xpovio (selinexor) • Ninlaro (ixazomib) • Darzalex (daratumumab) • carfilzomib • pomalidomide • Empliciti (elotuzumab) • Blenrep (belantamab mafodotin-blmf) • mezigdomide (CC-92480)
    3ms
    Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=33, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    GDF15 (Growth differentiation factor 15)
    |
    Ninlaro (ixazomib) • idasanutlin (RG7388)
    3ms
    MC1382: Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis (clinicaltrials.gov)
    P1/2, N=87, Active, not recruiting, Mayo Clinic | Trial completion date: Oct 2024 --> May 2025
    Trial completion date • Combination therapy
    |
    cyclophosphamide • Ninlaro (ixazomib)
    3ms
    Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Joseph Tuscano | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Ninlaro (ixazomib) • pomalidomide
    4ms
    IPoD-790: Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Tel-Aviv Sourasky Medical Center | Trial completion date: Oct 2024 --> Sep 2029 | Trial primary completion date: Sep 2024 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone • pomalidomide
    4ms
    Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, University of Chicago | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Post-transplantation
    |
    lenalidomide • Ninlaro (ixazomib) • dexamethasone
    4ms
    IPoD-790: Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Tel-Aviv Sourasky Medical Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone • pomalidomide
    4ms
    Integrated transcriptomics- and structure-based drug repositioning identifies drugs with proteasome inhibitor properties. (PubMed, Sci Rep)
    Here, we used an integrated drug repositioning approach based on transcriptomics data and structure-based virtual screening to identify compounds with gene signatures similar to three known proteasome inhibitors (PIs; bortezomib, MG-132, and MLN-2238)...Using this approach, we identified six compounds with PI properties ((-)-kinetin-riboside, manumycin-A, puromycin dihydrochloride, resistomycin, tegaserod maleate, and thapsigargin)...As shown with bortezomib, only manumycin-A, puromycin dihydrochloride, and tegaserod maleate resulted in excessive accumulation of ubiquitinated proteins and elevated HMOX1 expression. Taken together, our integrated drug repositioning approach and subsequent in vitro validation studies identified six compounds demonstrating properties similar to proteasome inhibitors.
    Journal
    |
    HMOX1 (Heme Oxygenase 1)
    |
    bortezomib • Ninlaro (ixazomib) • MG132
    4ms
    Association of KRAS Mutation and Gene Pathways in Colorectal Carcinoma: A Transcriptome- and Methylome-Wide Study and Potential Implications for Therapy. (PubMed, Int J Mol Sci)
    Our findings suggest the possibility of a better response to anti-CDKN2A therapy with Villosol in KRAS-mutant CRC. Also, the more marked up-regulation of genes in the proteasome pathway in CRC tissue, especially with the KRAS mutation and MSI, may suggest a potential role of a proteasome inhibitor (bortezomib, carfilzomib, or ixazomib) in selected CRC patients if necessary.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • MSI (Microsatellite instability) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
    |
    5-fluorouracil • bortezomib • Ninlaro (ixazomib) • carfilzomib
    5ms
    Ixazomib Rollover Study (clinicaltrials.gov)
    P2, N=31, Completed, Takeda | Active, not recruiting --> Completed | Trial completion date: Feb 2027 --> Jul 2024 | Trial primary completion date: Feb 2027 --> Jul 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Ninlaro (ixazomib)
    5ms
    Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients (clinicaltrials.gov)
    P4, N=211, Completed, Peking Union Medical College Hospital | Recruiting --> Completed | Trial completion date: Oct 2022 --> Jun 2024 | Trial primary completion date: Oct 2022 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • Ninlaro (ixazomib)
    5ms
    A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM) (clinicaltrials.gov)
    P=N/A, N=191, Completed, Takeda | Recruiting --> Completed | Trial completion date: Jun 2024 --> Aug 2023
    Trial completion • Trial completion date • Real-world evidence • Real-world
    |
    Ninlaro (ixazomib)
    5ms
    TOURMALINE-MM3: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant (clinicaltrials.gov)
    P3, N=656, Completed, Takeda | Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Sep 2023
    Trial completion • Trial completion date
    |
    Ninlaro (ixazomib)
    5ms
    Multicenter, prospective, open-label clinical study of ICD (Ixazomib / cyclophosphamide / dexamethasone) regimen for newly diagnosed POEMS syndrome (ChiCTR2000030072)
    P=N/A, N=20, Completed, Shanghai Changzheng Hospital; Shanghai Changzheng Hospital | Recruiting --> Completed
    Trial completion
    |
    VEGFA (Vascular endothelial growth factor A)
    |
    cyclophosphamide • Ninlaro (ixazomib)
    5ms
    SIZOMUS Safety of Ixazomib Targeting Plasma Cells in Multiple Sclerosis (clinicaltrials.gov)
    P1, N=72, Recruiting, Queen Mary University of London | Phase classification: P1b --> P1 | Trial completion date: Aug 2023 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Aug 2024
    Phase classification • Trial completion date • Trial primary completion date
    |
    NCAM1 (Neural cell adhesion molecule 1) • SDC1 (Syndecan 1) • CD27 (CD27 Molecule) • NEFH (Neurofilament Heavy) • GFAP (Glial Fibrillary Acidic Protein) • NEFL (Neurofilament Light Chain) • S100B (S100 Calcium Binding Protein B)
    |
    Ninlaro (ixazomib)
    6ms
    INFINITE: A Study of Ninlaro in Real World Clinical Practice in China (clinicaltrials.gov)
    P=N/A, N=482, Active, not recruiting, Takeda | Recruiting --> Active, not recruiting | N=3000 --> 482
    Enrollment closed • Enrollment change • Real-world evidence • Real-world
    |
    Ninlaro (ixazomib)
    6ms
    Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis (clinicaltrials.gov)
    P1, N=24, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1) • SDC1 (Syndecan 1) • BAX (BCL2-associated X protein)
    |
    Venclexta (venetoclax) • Ninlaro (ixazomib) • Hemady (dexamethasone tablets)
    6ms
    DeRIVE: Daratumumab, Ixazomib, & Dexamethasone or Daratumumab, Bortezomib, & Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=49, Active, not recruiting, Emory University | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
    6ms
    Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=80, Completed, Mayo Clinic | Active, not recruiting --> Completed
    Trial completion
    |
    lenalidomide • Ninlaro (ixazomib) • Darzalex (daratumumab)
    6ms
    Ixazomib Rollover Study (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Takeda | Trial completion date: Dec 2023 --> Feb 2027 | Trial primary completion date: Dec 2023 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    Ninlaro (ixazomib)
    6ms
    Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib (clinicaltrials.gov)
    P2, N=165, Active, not recruiting, Mayo Clinic | N=108 --> 165
    Enrollment change
    |
    bortezomib • cyclophosphamide • Ninlaro (ixazomib) • Darzalex (daratumumab) • Hemady (dexamethasone tablets) • dexamethasone injection
    7ms
    Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis (clinicaltrials.gov)
    P1, N=24, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Sep 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1) • SDC1 (Syndecan 1) • BAX (BCL2-associated X protein)
    |
    Venclexta (venetoclax) • Ninlaro (ixazomib) • Hemady (dexamethasone tablets)
    7ms
    Ixazomib Citrate With Gemcitabine Hydrochloride and Doxorubicin Hydrochloride in Treating Patients With Urothelial Cancer That is Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Surgery • Metastases
    |
    gemcitabine • doxorubicin hydrochloride • Ninlaro (ixazomib)
    7ms
    Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, University of Washington | Trial completion date: Jan 2025 --> Jan 2031
    Trial completion date
    |
    Rituxan (rituximab) • Ninlaro (ixazomib) • Truxima (rituximab-abbs)
    7ms
    Enhanced angiogenesis of human umbilical vein endothelial cells via THP-1-derived M2c-like macrophages and treatment with proteasome inhibitors 'bortezomib and ixazomib'. (PubMed, APMIS)
    To elucidate the role of macrophages in lung cancer and angiogenesis processes, we established an in vitro co-culture model of A549 or HUVEC with THP-1 cells that polarized to M2c macrophages with hydrocortisone. Additionally, bortezomib inhibited the VEGFB pathway in HUVEC and NFKB1 in A549 cells. The significant findings obtained as a result of this study will provide information regarding angiogenesis induced by M2 macrophages.
    Journal
    |
    VEGFB (Vascular Endothelial Growth Factor B)
    |
    bortezomib • Ninlaro (ixazomib)
    7ms
    Ixazomib (MLN9708) and Dexamethasone in High Risk Smoldering Multiple Myeloma: A Clinical and Correlative Pilot Study (clinicaltrials.gov)
    P1, N=14, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> May 2024 | Trial primary completion date: Feb 2025 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    Ninlaro (ixazomib) • dexamethasone
    8ms
    Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, University of California, San Diego | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Ninlaro (ixazomib) • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    8ms
    Id and Rd Maintenance Regimens After Induction of Remission in Multiple Myeloma. (clinicaltrials.gov)
    P=N/A, N=420, Recruiting, RenJi Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    lenalidomide • Ninlaro (ixazomib)
    8ms
    Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial (clinicaltrials.gov)
    P3, N=1, Active, not recruiting, National Cancer Institute (NCI) | N=510 --> 1 | Trial completion date: Mar 2024 --> Apr 2025 | Trial primary completion date: Mar 2024 --> Aug 2023
    Enrollment change • Trial completion date • Trial primary completion date
    |
    lenalidomide • Ninlaro (ixazomib)
    9ms
    Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM (clinicaltrials.gov)
    P2, N=18, Recruiting, Larysa Sanchez | N=38 --> 18 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Feb 2024 --> Dec 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    9ms
    NCI-2018-02830: Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=60 --> 40
    Enrollment closed • Enrollment change
    |
    bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
    9ms
    STOMP: Selinexor and Backbone Treatments of Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=300, Active, not recruiting, Karyopharm Therapeutics Inc | Phase classification: P1b/2 --> P1/2 | N=518 --> 300 | Trial completion date: Jan 2025 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Apr 2027
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • bortezomib • Xpovio (selinexor) • Ninlaro (ixazomib) • Darzalex (daratumumab) • carfilzomib • pomalidomide • Empliciti (elotuzumab) • Blenrep (belantamab mafodotin-blmf) • mezigdomide (CC-92480)