Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic efficacy and safety of ixazomib (MLN2238) across diverse oncologic indications, including multiple myeloma, acute myeloid leukemia, glioblastoma, soft tissue sarcomas, renal cell carcinoma, and AL amyloidosis. Conducted by pharmaceutical sponsors such as Millennium Pharmaceuticals and Takeda as well as academic institutions like Emory University and the University of Leeds, these studies range from early dose-escalation safety trials to pivotal Phase 3 combination regimens. Across this body of research, recruitment statuses encompass completed, currently recruiting, active, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04998786 ACTIVE_NOT_RECRUITING
Multiple Myeloma at First Relapse
Nantes University Hospital
 2021-12-14 PHASE2
NCT04305691 RECRUITING
Kaposi Sarcoma; Skin
AIDS Malignancy Consortium
 2023-11-07 PHASE2
NCT04847453 ACTIVE_NOT_RECRUITING
Recurrent AL Amyloidosis; Refractory AL Amyloidosis
National Cancer Institute (NCI)
 2022-08-03 PHASE1
NCT06744894 NOT_YET_RECRUITING
Multiple Myeloma
Navy General Hospital, Beijing
 2025-01-01 PHASE2
NCT03376672 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Raija Silvennoinen
 2018-05-31 PHASE2
NCT03763162 ACTIVE_NOT_RECRUITING
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
M.D. Anderson Cancer Center
 2019-01-17 PHASE2
NCT04790474 ACTIVE_NOT_RECRUITING
Multiple Myeloma in Relapse; Refractory Multiple Myeloma
Tel-Aviv Sourasky Medical Center
 2021-03-25 PHASE2
NCT05451771 ACTIVE_NOT_RECRUITING
AL Amyloidosis
Columbia University
 2022-10-26 PHASE1; PHASE2
NCT02343042 RECRUITING
Multiple Myeloma
Karyopharm Therapeutics Inc
 2015-10 PHASE1; PHASE2
NCT04068597 RECRUITING
Haematological Malignancy; Acute Myeloid Leukemia; Non Hodgkin Lymphoma; Multiple Myeloma; Higher-risk Myelodysplastic Syndrome; Peripheral T Cell Lymphoma
CellCentric Ltd.
 2019-08-09 PHASE1; PHASE2
NCT05183139 WITHDRAWN
Multiple Myeloma
Takeda
 2022-06-30 PHASE4
NCT04009109 ACTIVE_NOT_RECRUITING
Myeloma, Multiple
Alliance Foundation Trials, LLC.
 2020-10-21 PHASE2
NCT06050512 WITHDRAWN
Relapsed and Refractory Multiple Myeloma
Kathleen Dorritie
 2023-10-02 PHASE1; PHASE2
NCT03587662 COMPLETED
Metastatic Kidney Medullary Carcinoma; Metastatic Renal Cell Carcinoma; SMARCB1 Negative; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8
M.D. Anderson Cancer Center
 2018-08-17 PHASE2
NCT03618537 ACTIVE_NOT_RECRUITING
AL Amyloidosis
Memorial Sloan Kettering Cancer Center
 2018-08-02 PHASE2
NCT03783416 RECRUITING
Relapsing Remitting Multiple Sclerosis; Primary Progressive Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
Queen Mary University of London
 2020-06-15 PHASE1
NCT05722405 RECRUITING
Multiple Myeloma
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2022-07-01 PHASE4
NCT03896737 ACTIVE_NOT_RECRUITING
Multiple Myeloma
European Myeloma Network B.V.
 2019-04-16 PHASE2
NCT03283917 COMPLETED
Newly Diagnosed Primary Amyloidosis; Recurrent Primary Amyloidosis; Refractory Primary Amyloidosis
M.D. Anderson Cancer Center
 2018-02-07 PHASE1
NCT03616782 UNKNOWN
Mantle Cell Lymphoma
Ho Sup Lee
 2018-12-24 PHASE2
NCT03651128 COMPLETED
Multiple Myeloma
Celgene
 2019-04-16 PHASE3
NCT03173092 TERMINATED
Multiple Myeloma
Takeda
 2017-11-13 PHASE4
NCT03562169 RECRUITING
Multiple Myeloma
University of Leeds
 2017-03-20 PHASE3
NCT05477797 UNKNOWN
Progression Free Survival; Overall Survival; Maintenance
RenJi Hospital
 2023-02-16
NCT02420847 ACTIVE_NOT_RECRUITING
Metastatic Urothelial Carcinoma; Transitional Cell Carcinoma; Unresectable Transitional Cell Carcinoma
M.D. Anderson Cancer Center
 2015-07-03 PHASE1; PHASE2
NCT02542657 ACTIVE_NOT_RECRUITING
Myeloma
Joseph Tuscano
 2015-10 PHASE1; PHASE2
NCT03942224 UNKNOWN
Plasma Cell Myeloma
Emory University
 2019-07-03 PHASE2
NCT03590652 TERMINATED
Relapsed/Refractory Multiple Myeloma
University of California, San Diego
 2018-10-17 PHASE2
NCT04094961 ACTIVE_NOT_RECRUITING
Multiple Myeloma; Multiple Myeloma in Relapse
Omar Nadeem, MD
 2019-09-18 PHASE1; PHASE2
NCT04052880 ACTIVE_NOT_RECRUITING
Newly Diagnosed Multiple Myeloma
Larysa Sanchez
 2019-10-24 PHASE2
NCT05675319 TERMINATED
Multiple Myeloma
Universitätsklinikum Hamburg-Eppendorf
 2023-03-03 PHASE3
NCT02916771 COMPLETED
Smoldering Multiple Myeloma
Dana-Farber Cancer Institute
 2016-10 PHASE2
NCT03732703 COMPLETED
Relapsed Refractory Multiple Myeloma
Multiple Myeloma Research Consortium
 2019-04-01 PHASE1; PHASE2
NCT02339922 ACTIVE_NOT_RECRUITING
Chronic Lymphocytic Leukemia; Follicular Lymphoma; Lymphoplasmacytic Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Small Lymphocytic Lymphoma; Waldenstrom Macroglobulinemia
University of Washington
 2016-05-19 PHASE2
NCT03720041 UNKNOWN
Multiple Myeloma
University of Leeds
 2020-08-04 PHASE3
NCT02516423 TERMINATED
Solitary Osseous Plasmacytoma
Alliance for Clinical Trials in Oncology
 2016-11-29 PHASE3
NCT04989140 UNKNOWN
Multiple Myeloma
Peking Union Medical College Hospital
 2021-07-26 PHASE4
NCT02924272 COMPLETED
Multiple Myeloma; Lymphoma; Amyloidosis
Takeda
 2016-12-16 PHASE2
NCT04217967 COMPLETED
Multiple Myeloma
Peking Union Medical College Hospital
 2019-09-24 PHASE4
NCT04047797 TERMINATED
Recurrent Mantle Cell Lymphoma; Refractory Mantle Cell Lymphoma
M.D. Anderson Cancer Center
 2019-08-28 PHASE2
NCT02697383 COMPLETED
Multiple Myeloma; High Risk Smoldering Multiple Myeloma
Memorial Sloan Kettering Cancer Center
 2016-02 PHASE1
NCT03731832 COMPLETED
Refractory Multiple Myeloma
GWT-TUD GmbH
 2018-09-20 PHASE2
NCT04028115 COMPLETED
Multiple Myeloma
Thomas Lund
 2019-10-24 PHASE2
NCT03669445 UNKNOWN
Multiple Myeloma
University Hospital, Toulouse
 2018-12-31 PHASE2
NCT04837131 TERMINATED
Systemic Sclerosis; Scleroderma; Diffuse Systemic Sclerosis; Diffuse Scleroderma; Diffuse Cutaneous Systemic Sclerosis; Diffuse Cutaneous Scleroderma; Progressive Systemic Sclerosis; Progressive Scleroderma; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma;Progressive; Systemic Sclerosis, Diffuse; Systemic; Sclerosis, Progressive; Scleroderma of Lung; Scleroderma With Pulmonary Involvement; Systemic Sclerosis Pulmonary; Systemic Sclerosis With Lung Involvement; Interstitial Lung Disease; Pulmonary Fibrosis Interstitial
Michael M. Pham
 2021-04-28 PHASE2
NCT03225417 UNKNOWN
Hematopoietic Stem Cell Transplantation; Multiple Myeloma
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2017-05-16 PHASE1; PHASE2
NCT03748953 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2019-01-24 PHASE3
NCT03817320 ACTIVE_NOT_RECRUITING
ALL, Childhood; Lymphoblastic Lymphoma, Childhood; Lymphoblastic Leukemia, Acute, Childhood
Therapeutic Advances in Childhood Leukemia Consortium
 2019-02-12 PHASE1; PHASE2
NCT03733691 TERMINATED
Newly Diagnosed Multiple Myeloma
Oncotherapeutics
 2019-03-01 PHASE2
NCT02632396 UNKNOWN
Mantle Cell Lymphoma
Emory University
 2016-03-01 PHASE1; PHASE2
NCT03941860 COMPLETED
Multiple Myeloma
National Cancer Institute (NCI)
 2022-02-16 PHASE3
NCT02765854 COMPLETED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Emory University
 2016-09-01 PHASE2
NCT01415882 COMPLETED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Mayo Clinic
 2012-01-31 PHASE2
NCT01718743 COMPLETED
Hematopoietic Cell Transplantation Recipient; Plasma Cell Myeloma
M.D. Anderson Cancer Center
 2012-12-03 PHASE2
NCT03965624 WITHDRAWN
Immune Thrombocytopenia; Warm Autoimmune Hemolytic Anemia
Assistance Publique - Hôpitaux de Paris
 2019-09-01 PHASE2
NCT03506373 TERMINATED
Recurrent Waldenstrom Macroglobulinemia; Refractory Waldenstrom Macroglobulinemia; Waldenstrom Macroglobulinemia
Mayo Clinic
 2018-08-14 PHASE2
NCT03683277 TERMINATED
Multiple Myeloma; Relapsed and Refractory Multiple Myeloma; Genetic Condition
Intergroupe Francophone du Myelome
 2019-11-03 PHASE2
NCT03012880 COMPLETED
Plasma Cell Myeloma
Mayo Clinic
 2017-04-20 PHASE2
NCT02942095 COMPLETED
Solid Tumors
M.D. Anderson Cancer Center
 2017-03-06 PHASE1
NCT04463953 COMPLETED
Waldenström Macroglobulinemia
Institute of Hematology & Blood Diseases Hospital, China
 2020-06-01 PHASE2
NCT03457142 TERMINATED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Roswell Park Cancer Institute
 2018-09-11 PHASE2
NCT03323151 COMPLETED
Mantle-Cell Lymphoma
PrECOG, LLC.
 2018-08-13 PHASE1; PHASE2
NCT03236792 COMPLETED
AL Amyloidosis
Icahn School of Medicine at Mount Sinai
 2017-06-12 PHASE1; PHASE2
NCT03757221 TERMINATED
Multiple Myeloma
University Hospital, Caen
 2019-02-07 PHASE2
NCT03770260 COMPLETED
Recurrent Multiple Myeloma; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2020-02-10 PHASE1
NCT03888534 WITHDRAWN
Precursor Cell Lymphoblastic Leukemia-lymphoma
Millennium Pharmaceuticals, Inc.
 2020-10-31 PHASE1
NCT01659658 TERMINATED
Relapsed or Refractory Systemic Light Chain Amyloidosis
Millennium Pharmaceuticals, Inc.
 2012-12-26 PHASE3
NCT02619682 COMPLETED
Plasma Cell Myeloma; Transplant-Related Carcinoma
Fred Hutchinson Cancer Center
 2015-12-30 PHASE2
NCT02921893 COMPLETED
Plasmacytoma; POEMS Syndrome
Mayo Clinic
 2016-10-31 EARLY_PHASE1
NCT02461888 COMPLETED
Multiple Myeloma
University of Leeds
 2015-12 PHASE2
NCT03439293 COMPLETED
Multiple Myeloma
Takeda
 2018-03-13 PHASE2
NCT03856112 WITHDRAWN
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma; t(11;14) Negative
National Cancer Institute (NCI)
 2019-06-21 PHASE1; PHASE2
NCT03399539 COMPLETED
Recurrent Plasma Cell Myeloma; T(11;14)
Mayo Clinic
 2018-05-02 PHASE1
NCT02004275 UNKNOWN
Multiple Myeloma in Relapse
Alliance for Clinical Trials in Oncology
 2014-02 PHASE1; PHASE2
NCT03746652 UNKNOWN
Multiple Myeloma
Hellenic Society of Hematology
 2018-12 PHASE2
NCT04079738 TERMINATED
AML; AML, Adult
H Scott Boswell
 2019-09-20 PHASE1; PHASE2
NCT03082677 COMPLETED
Myeloid Hematologic Malignancy; Lymphoid Hematologic Malignancy
Memorial Sloan Kettering Cancer Center
 2017-03-10 PHASE2
NCT03608501 WITHDRAWN
Multiple Myeloma
Takeda
 2019-09-30 PHASE2
NCT03416374 COMPLETED
Relapsed and/or Refractory Multiple Myeloma
Takeda
 2018-02-18 PHASE4
NCT01864018 COMPLETED
Amyloidosis; Plasma Cell Myeloma
Mayo Clinic
 2013-08-20 PHASE1; PHASE2
NCT03213158 COMPLETED
Kidney Diseases; End Stage Renal Disease
University of Wisconsin, Madison
 2017-09-15 PHASE2
NCT03202628 COMPLETED
Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
Mayo Clinic
 2017-07-24 PHASE2
NCT02389517 COMPLETED
Plasma Cell Myeloma; Residual Disease
University of Chicago
 2015-03-02 PHASE2
NCT02633059 COMPLETED
Loss of Chromosome 17p; Recurrent Plasma Cell Myeloma
Mayo Clinic
 2015-12-30 PHASE1; PHASE2
NCT03880123 WITHDRAWN
Liposarcoma; Malignant Peripheral Nerve Sheath Tumors; Alveolar Soft Part Sarcoma; Ewing Sarcoma; Sarcoma
Matthew Ingham
 2020-11 PHASE1
NCT02831686 COMPLETED
Multiple Myeloma; Relapsed and/or Refractory Multiple Myeloma
Memorial Sloan Kettering Cancer Center
 2016-07 PHASE1
NCT04119336 TERMINATED
Relapsed Multiple Myeloma; Refractory Multiple Myeloma
Andrew Yee, MD
 2020-02-14 PHASE2
NCT02547662 COMPLETED
Plasma Cell Leukemia; Plasma Cell Myeloma; Plasmacytoma
Mayo Clinic
 2015-12-24 PHASE2
NCT02440464 COMPLETED
Multiple Myeloma
National Heart, Lung, and Blood Institute (NHLBI)
 2015-08 PHASE2
NCT02481310 UNKNOWN
Adult Burkitt Lymphoma; B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma; MYC Gene Mutation; Plasmablastic Lymphoma
Northwestern University
 2015-10-28 PHASE1; PHASE2
NCT02504359 COMPLETED
Plasma Cell Leukemia; Recurrent Plasma Cell Myeloma
OHSU Knight Cancer Institute
 2015-07-20 PHASE1
NCT03547700 TERMINATED
Lymphoma, T-Cell, Peripheral
University of Michigan Rogel Cancer Center
 2018-09-26 PHASE1; PHASE2
NCT02993094 TERMINATED
Triple-Negative Breast Cancer
Arbeitsgemeinschaft medikamentoese Tumortherapie
 2016-11-21 PHASE1; PHASE2
NCT03170882 COMPLETED
Relapsed and/or Refractory Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2017-08-01 PHASE2
NCT02253316 ACTIVE_NOT_RECRUITING
Multiple Myeloma
Washington University School of Medicine
 2015-01-20 PHASE2
NCT03492138 TERMINATED
Multiple Myeloma
Ajai Chari
 2018-03-26 PHASE1; PHASE2
NCT01850524 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2013-04-29 PHASE3
NCT03506360 COMPLETED
Recurrent Plasma Cell Myeloma
Mayo Clinic
 2018-06-19 PHASE2
NCT02400437 COMPLETED
Waldenstrom's Macroglobulinemia
Dana-Farber Cancer Institute
 2015-04 PHASE2
NCT02917941 COMPLETED
Relapsed and/or Refractory Multiple Myeloma
Takeda
 2016-11-01 PHASE2
NCT02946047 COMPLETED
Human Immunodeficiency Virus (HIV)
Mayo Clinic
 2017-03-20 PHASE1; PHASE2
NCT02312258 COMPLETED
Multiple Myeloma
Takeda
 2015-04-09 PHASE3
NCT02412228 COMPLETED
Multiple Myeloma
John L. Reagan
 2015-08 PHASE2
NCT02410694 COMPLETED
Multiple Myeloma
Arbeitsgemeinschaft medikamentoese Tumortherapie
 2015-04 PHASE2
NCT04272775 TERMINATED
Relapsed and/or Refractory Multiple Myeloma
Takeda
 2012-06-05 PHASE1
NCT01318902 COMPLETED
Light-Chain Amyloidosis
Millennium Pharmaceuticals, Inc.
 2011-04-27 PHASE1
NCT02897830 TERMINATED
Multiple Myeloma
University Hospital, Toulouse
 2016-08-05 PHASE2
NCT02898259 TERMINATED
B Cell Lymphoma; Lymphoma
Brian Hill
 2017-02-20 PHASE1; PHASE2
NCT02630030 COMPLETED
Glioblastoma
Emory University
 2016-03-24 EARLY_PHASE1
NCT02046070 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2014-03-05 PHASE2
NCT02499081 COMPLETED
Multiple Myeloma
University of Arkansas
 2015-09 PHASE2
NCT02057640 COMPLETED
Multiple Myeloma; Kahler Disease; Plasma-Cell Myeloma; Myelomatosis
Jason Valent
 2014-05-22 PHASE1; PHASE2
NCT02477215 COMPLETED
Multiple Myeloma
Parameswaran Hari
 2015-10-09 PHASE1; PHASE2
NCT02181413 COMPLETED
Multiple Myeloma; Autologous Stem Cell Transplant
Takeda
 2014-07-16 PHASE3
NCT02578511 WITHDRAWN
Acute Lymphoblastic Leukemia in Complete Remission; Lymphoblastic Lymphoma in Complete Remission; Mixed Phenotype Acute Leukemia in Complete Remission
Ehab L Atallah
 2017-06-29 PHASE1
NCT02206425 COMPLETED
Multiple Myeloma
Oncotherapeutics
 2014-09 PHASE1; PHASE2
NCT02513498 COMPLETED
Chronic Graft Versus Host Disease
Fred Hutchinson Cancer Center
 2015-12-08 PHASE2
NCT02302846 TERMINATED
Leukemia
M.D. Anderson Cancer Center
 2015-03-20 PHASE2
NCT02447887 TERMINATED
Metastatic Renal Cell Carcinoma; RCC
Fox Chase Cancer Center
 2015-08-14 PHASE1; PHASE2
NCT02176486 TERMINATED
Lupus Nephritis
Takeda
 2014-06-09 PHASE1
NCT02070458 COMPLETED
Recurrent Adult Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Case Comprehensive Cancer Center
 2014-10-08 PHASE1
NCT02578121 WITHDRAWN
Multiple Myeloma
University of Arkansas
 2015-12 PHASE2
NCT01335685 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2011-06-27 PHASE1; PHASE2
NCT02158975 COMPLETED
Lymphoma, T-Cell
University of Michigan Rogel Cancer Center
 2014-09 PHASE2
NCT01939899 COMPLETED
Follicular Lymphoma
Millennium Pharmaceuticals, Inc.
 2013-10-31 PHASE2
NCT02119468 COMPLETED
Refractory Plasma Cell Myeloma; Recurrent Plasma Cell Myeloma
City of Hope Medical Center
 2014-06-30 PHASE1; PHASE2
NCT01887587 TERMINATED
Relapsed or Refractory Acute Lymphoblastic Leukemia; Relapsed or Refractory Lymphoblastic Lymphoma; Mixed Phenotype Acute Leukemia
Ehab L Atallah
 2013-06 PHASE1
NCT02030405 TERMINATED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Steven E. Coutre
 2014-03 PHASE2
NCT01454076 COMPLETED
Nonhematologic Malignancies; Lymphoma
Millennium Pharmaceuticals, Inc.
 2011-11-10 PHASE1
NCT01830816 COMPLETED
Multiple Myeloma; Advanced Solid Tumors
Millennium Pharmaceuticals, Inc.
 2013-09-16 PHASE1
NCT01912222 COMPLETED
Advanced Solid Tumors; Hematologic Malignancies
Millennium Pharmaceuticals, Inc.
 2013-08 PHASE1
NCT01953783 COMPLETED
Advanced Solid Tumors; Lymphoma
Millennium Pharmaceuticals, Inc.
 2014-03-19 PHASE1
NCT01383928 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2011-10-31 PHASE1; PHASE2
NCT01564537 COMPLETED
Relapsed Multiple Myeloma; Refractory Multiple Myeloma
Takeda
 2012-08-01 PHASE3
NCT00893464 COMPLETED
Lymphoma
Millennium Pharmaceuticals, Inc.
 2009-08 PHASE1
NCT01645930 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2012-12-17 PHASE1
NCT00932698 COMPLETED
Relapsed and Refractory Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2009-10-12 PHASE1
NCT01217957 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2010-11-22 PHASE1; PHASE2
NCT00963820 COMPLETED
Multiple Myeloma
Millennium Pharmaceuticals, Inc.
 2009-10 PHASE1
NCT00830869 COMPLETED
Advanced Non-hematologic Malignancies
Millennium Pharmaceuticals, Inc.
 2009-03-02 PHASE1
NCT00963820 Completed
Multiple Myeloma
Millennium Pharmaceuticals Inc.|Takeda
 2009-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-15)

Check the MLN2238 (Ixazomib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ixazomib (MLN2238) reversibly binds to and inhibits the β5 chymotrypsin-like proteolytic subunit of the 20S proteasome, disrupting intracellular protein degradation pathways and triggering cytotoxic cellular effects including autophagy. This targeted inhibition of proteasomal activity leads to tumor cell apoptosis, suppressing growth in preclinical models and clinical trial indications such as multiple myeloma, glioblastoma, and various sarcomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.