Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
Open accessAbstract
BACKGROUND: Ixazomib is an oral proteasome inhibitor that is currently being studied for the treatment of multiple myeloma. METHODS: In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had relapsed, refractory, or relapsed and refractory multiple myeloma to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomide-dexamethasone (placebo group). The primary end point was progression-free survival. RESULTS: Progression-free survival was significantly longer in the ixazomib group than in the placebo group at a median follow-up of 14.7 months (median progression-free survival, 20.6 months vs. 14.7 months; hazard ratio for disease progression or death in the ixazomib group, 0.74; P=0.01); a benefit with respect to progression-free survival was observed with the ixazomib regimen, as compared with the placebo regimen, in all prespecified patient subgroups, including in patients with high-risk cytogenetic abnormalities. The overall rates of response were 78% in the ixazomib group and 72% in the placebo group, and the corresponding rates of complete response plus very good partial response were 48% and 39%. The median time to response was 1.1 months in the ixazomib group and 1.9 months in the placebo group, and the corresponding median duration of response was 20.5 months and 15.0 months. At a median follow-up of approximately 23 months, the median overall survival has not been reached in either study group, and follow-up is ongoing. The rates of serious adverse events were similar in the two study groups (47% in the ixazomib group and 49% in the placebo group), as were the rates of death during the study period (4% and 6%, respectively); adverse events of at least grade 3 severity occurred in 74% and 69% of the patients, respectively. Thrombocytopenia of grade 3 and grade 4 severity occurred more frequently in the ixazomib group (12% and 7% of the patients, respectively) than in the placebo group (5% and 4% of the patients, respectively). Rash occurred more frequently in the ixazomib group than in the placebo group (36% vs. 23% of the patients), as did gastrointestinal adverse events, which were predominantly low grade. The incidence of peripheral neuropathy was 27% in the ixazomib group and 22% in the placebo group (grade 3 events occurred in 2% of the patients in each study group). Patient-reported quality of life was similar in the two study groups. CONCLUSIONS: The addition of ixazomib to a regimen of lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with this all-oral regimen were limited. (Funded by Millennium Pharmaceuticals; TOURMALINE-MM1 ClinicalTrials.gov number, NCT01564537.).
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In a randomized controlled trial in relapsed multiple myeloma, ixazomib, lenalidomide, dexamethasone (IRd) improved progression-free survival compared with lenalidomide and dexamethasone (Rd).
“In a randomized controlled trial in relapsed multiple myeloma, ixazomib, lenalidomide, dexamethasone (IRd) was found to improve PFS compared with Rd (Table 8).73”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [73]
Ixazomib is active in both the relapsed refractory setting and in newly diagnosed multiple myeloma.
“Ixazomib is an oral proteasome inhibitor that is active in both the relapsed refractory setting and in newly diagnosed multiple myeloma.73,174”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [73]
Daratumumab with lenalidomide and dexamethasone was associated with clinically manageable adverse events that were consistent with the known toxic effects of lenalidomide and dexamethasone and of daratumumab.
“Daratumumab with lenalidomide and dexamethasone was associated with clinically manageable adverse events that were consistent with the known toxic effects of lenalidomide and dexamethasone 27,28,30,31 and of daratumumab.9,10”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [28]
Pomalidomide is most often used in combination with dexamethasone, either alone or as part of triplet regimens with bortezomib, daratumumab or elotuzumab.
“Pomalidomide is most often used in combination with dexamethasone, either alone or as part of triplet regimens with a variety of other anti-myeloma agents, including bortezomib45, daratumumab46 or elotuzumab47.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [47]
Elotuzumab has no anti-myeloma activity as monotherapy, but the addition of elotuzumab to lenalidomide or pomalidomide and dexamethasone improved ORRs, PFS and OS in patients with R/R MM.
“The anti-SLAMF7 antibody elotuzumab has no anti-myeloma activity as monotherapy65, but the addition of this agent to lenalidomide or pomalidomide and dexamethasone improved ORRs, PFS and OS in patients with R/R MM47,66,67.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [47]
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- Authors
- Moreau, P., Masszi, T., Grzasko, N., Bahlis, N. J., Hansson, M., Pour, L., Sandhu, I., Ganly, P., Baker, B. W., Jackson, S. R., Stoppa, A.-M., Simpson, D. R., Gimsing, P., Palumbo, A., Garderet, L., Cavo, M., Kumar, S., Touzeau, C., Buadi, F. K., Laubach, J. P., Berg, D. T., Lin, J., Di Bacco, A., Hui, A.-M., van de Velde, H., & Richardson, P. G.
- Affiliations
- Semmelweis University (HU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-04-28
- Volume
- 374
- Issue
- 17
- Pages
- 1621-1634
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2343386476
- Semantic Scholar
- 41ad797a130c75d61f9e714e6a064eaea6d8f85d
- Cited by
- 1,060
- References
- 32
- Citations by year
- 2026: 39 · 2025: 69 · 2024: 53 · 2023: 80 · 2022: 103 · 2021: 139 · 2020: 124 · 2019: 113 · 2018: 151 · 2017: 132 · 2016: 56 · 2014: 1
- FWCI
- 143.71
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Digital Access to Libraries (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Funders
- Takeda Oncology
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- ixazomib, lenalidomide, dexamethasone, multiple myeloma, relapsed/refractory multiple myeloma, oral proteasome inhibitor, progression-free survival, thrombocytopenia, rash, adverse events, chromosomal abnormalities, overall survival, complete response, time to response, duration of response, treatment safety and efficacy comparison
- MeSH terms
- Lenalidomide, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Dexamethasone, Double-Blind Method, Exanthema, Glycine, Humans, Male, Middle Aged, Multiple Myeloma, Quality of Life, Thalidomide, Thrombocytopenia, Proportional Hazards Models, Disease-Free Survival, Kaplan-Meier Estimate
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