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Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma. Br J Haematol 2017 08;178(4):571-582 PMID: 28485007 PMCID: PMC5574012

Pubmed ID

28485007

DOI

10.1111/bjh.14733

Abstract

The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.

Author List

Kumar S, Moreau P, Hari P, Mateos MV, Ludwig H, Shustik C, Masszi T, Spencer A, Hájek R, Romeril K, Avivi I, Liberati AM, Minnema MC, Einsele H, Lonial S, Berg D, Lin J, Gupta N, Esseltine DL, Richardson PG

Author

Parameswaran Hari MD Chief, Professor in the Medicine department at Medical College of Wisconsin




Scopus

2-s2.0-85019089968   17 Citations

MESH terms used to index this publication - Major topics in bold

Administration, Oral
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
Boron Compounds
Dexamethasone
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Eruptions
Follow-Up Studies
Glycine
Hematologic Diseases
Humans
Leukocyte Count
Male
Middle Aged
Multiple Myeloma
Nausea
Peripheral Nervous System Diseases
Platelet Count
Thalidomide
Vomiting
jenkins-FCD Prod-331 a335b1a6d1e9c32173c9534e6f6ff51494143916