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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
15d
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
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B2M (Beta-2-microglobulin)
|
Ninlaro (ixazomib) • dexamethasone • thalidomide
1m
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)
1m
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
1m
Trial completion date
|
lenalidomide • Ninlaro (ixazomib)
2ms
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
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bortezomib • Ninlaro (ixazomib) • carfilzomib
2ms
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)
2ms
Trial completion • Combination therapy
|
GDF15 (Growth differentiation factor 15)
|
Ninlaro (ixazomib) • idasanutlin (RG7388)
2ms
Trial completion date • Combination therapy
|
cyclophosphamide • Ninlaro (ixazomib)
2ms
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
3ms
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
3ms
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
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lenalidomide • Ninlaro (ixazomib) • dexamethasone
3ms
Enrollment closed
|
lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone • pomalidomide
3ms
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
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HMOX1 (Heme Oxygenase 1)
|
bortezomib • Ninlaro (ixazomib) • MG132
3ms
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
3ms
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)
4ms
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)
4ms
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)
4ms
Trial completion • Trial completion date
|
Ninlaro (ixazomib)
4ms
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)
4ms
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)
4ms
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)
5ms
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)
5ms
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
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bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
5ms
Trial completion
|
lenalidomide • Ninlaro (ixazomib) • Darzalex (daratumumab)
5ms
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)
5ms
Enrollment change
|
bortezomib • cyclophosphamide • Ninlaro (ixazomib) • Darzalex (daratumumab) • Hemady (dexamethasone tablets) • dexamethasone injection
5ms
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)
6ms
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)
6ms
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)
6ms
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)
6ms
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
7ms
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)
7ms
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)
7ms
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)
8ms
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)
8ms
Enrollment closed • Enrollment change
|
bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
8ms
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)
8ms
Trial completion
|
Ninlaro (ixazomib) • pomalidomide
8ms
Ixazomib + Pomalidomide + Dexamethasone In MM (clinicaltrials.gov)
P1/2, N=61, Recruiting, Omar Nadeem, MD | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
Trial completion date • Trial primary completion date
|
Ninlaro (ixazomib) • pomalidomide
8ms
Trial completion • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2)
|
Chr t(11;14)
|
Venclexta (venetoclax) • Ninlaro (ixazomib)
9ms
Ixazomib (MLN9708) and Dexamethasone in High Risk Smoldering Multiple Myeloma: A Clinical and Correlative Pilot Study (clinicaltrials.gov)
P1, N=14, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date
|
Ninlaro (ixazomib) • dexamethasone
9ms
ctDNA improves prognostic prediction in relapsed/refractory MM receiving ixazomib, lenalidomide, and dexamethasone. (PubMed, Blood)
Serial analysis of ctDNA mutations in 94 cases revealed that TP53 and KRAS mutations frequently emerge after therapy. Thus, we clarify the genetic characteristics and clonal architecture of ctDNA mutations and demonstrate their superiority over BMPC mutations for prognostic prediction in RRMM.
Journal • Circulating tumor DNA
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
TP53 mutation • KRAS mutation • BRAF mutation • NRAS mutation • ATM mutation • TP53 mutation + KRAS mutation
|
lenalidomide • Ninlaro (ixazomib) • dexamethasone