Please use this identifier to cite or link to this item: https://doi.org/10.1200/JCO.20.02060
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dc.titleIxazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial
dc.contributor.authorDimopoulos, Meletios A
dc.contributor.authorSpicka, Ivan
dc.contributor.authorQuach, Hang
dc.contributor.authorOriol, Albert
dc.contributor.authorHajek, Roman
dc.contributor.authorGarg, Mamta
dc.contributor.authorBeksac, Meral
dc.contributor.authorBringhen, Sara
dc.contributor.authorKatodritou, Eirini
dc.contributor.authorChng, Wee-Joo
dc.contributor.authorLeleu, Xavier
dc.contributor.authorIida, Shinsuke
dc.contributor.authorMateos, Maria-Victoria
dc.contributor.authorMorgan, Gareth
dc.contributor.authorVorog, Alexander
dc.contributor.authorLabotka, Richard
dc.contributor.authorWang, Bingxia
dc.contributor.authorPalumbo, Antonio
dc.contributor.authorLonial, Sagar
dc.date.accessioned2022-07-24T04:23:44Z
dc.date.available2022-07-24T04:23:44Z
dc.date.issued2020-12-01
dc.identifier.citationDimopoulos, Meletios A, Spicka, Ivan, Quach, Hang, Oriol, Albert, Hajek, Roman, Garg, Mamta, Beksac, Meral, Bringhen, Sara, Katodritou, Eirini, Chng, Wee-Joo, Leleu, Xavier, Iida, Shinsuke, Mateos, Maria-Victoria, Morgan, Gareth, Vorog, Alexander, Labotka, Richard, Wang, Bingxia, Palumbo, Antonio, Lonial, Sagar (2020-12-01). Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. JOURNAL OF CLINICAL ONCOLOGY 38 (34). ScholarBank@NUS Repository. https://doi.org/10.1200/JCO.20.02060
dc.identifier.issn0732183X
dc.identifier.issn15277755
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/229088
dc.description.abstractPURPOSE Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed. PATIENTS AND METHODS The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization. RESULTS Patients were randomly assigned to receive ixazomib (n 5 425) or placebo (n 5 281). TOURMALINEMM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4 v 9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801; P,.001; median follow-up, 21.1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25.6 v 12.9 months; HR, 0.586; P,.001). With ixazomib versus placebo, 36.6% versus 23.2% of patients had grade $ 3 treatment-emergent adverse events (TEAEs); 12.9% versus 8.0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26.8% v 8.0%), vomiting (24.2% v 4.3%), and diarrhea (23.2% v 12.3%). There was no increase in new primary malignancies (5.2% v 6.2%); rates of on-study deaths were 2.6% versus 2.2%. CONCLUSION Ixazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.
dc.language.isoen
dc.publisherAMER SOC CLINICAL ONCOLOGY
dc.sourceElements
dc.subjectScience & Technology
dc.subjectLife Sciences & Biomedicine
dc.subjectOncology
dc.subjectCONTINUOUS THERAPY
dc.subjectPLUS LENALIDOMIDE
dc.subjectFIXED DURATION
dc.subjectDOUBLE-BLIND
dc.subjectOPEN-LABEL
dc.subjectBORTEZOMIB
dc.subjectDEXAMETHASONE
dc.subjectOUTCOMES
dc.subjectDARATUMUMAB
dc.subjectPREDNISONE
dc.typeArticle
dc.date.updated2022-07-17T12:07:41Z
dc.contributor.departmentDEAN'S OFFICE (MEDICINE)
dc.description.doi10.1200/JCO.20.02060
dc.description.sourcetitleJOURNAL OF CLINICAL ONCOLOGY
dc.description.volume38
dc.description.issue34
dc.published.statePublished
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