International uniform response criteria for multiple myeloma

Durie, Brian G.M.; Harousseau, Jean Luc; Miguel, Jesús San; Bladé, Joan; Barlogie, Bart; Anderson, Kenneth C.; Gertz, Morie A.; Dimopoulos, Meletios Α.; Westin, Jan; Sonneveld, Pieter; Ludwig, Heinz; Gahrton, Gösta; Beksaç, Meral; Crowley, John; Belch, Andrew; Boccadaro, M.; Turesson, Ingemar; Joshua, Douglas; Vesole, David H.; Kyle, Robert A.; Alexanian, Raymond; Tricot, Guido; Attal, Michel; Merlini, Giampaolo; Powles, R; Richardson, Paul G.; Shimizu, Kazuyuki; Tosi, Patrizia; Morgan, G. W.; Rajkumar, S. Vincent

doi:10.1038/sj.leu.2404284

Cited by 2,364 publications

(1,925 citation statements)

References 27 publications

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“…Key inclusion criteria included measurable, symptomatic MM according to International Myeloma Working Group (IMWG) criteria (Durie et al , 2006); RRMM after receiving ≥2 lines of therapy (including a PI or IMiD), including lack of response or disease progression (according to IMWG response criteria; Rajkumar et al , 2014) to the most recent line of therapy; and Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Key exclusion criteria were an absolute neutrophil count <0·75 × 10 9 /l; platelet count <50 × 10 9 /l; creatinine level >221 μmol/l; peripheral neuropathy grade ≥2; and a need for concomitant warfarin or other vitamin K antagonists or strong CYP3A4/5 inhibitors (Indiana University Department of Medicine 2016).…”

Section: Methodsmentioning

confidence: 99%

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Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results

et al. 2018

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SummaryNovel therapies with unique new targets are needed for patients who are relapsed/refractory to current treatments for multiple myeloma. Ibrutinib is a first‐in‐class, once‐daily, oral covalent inhibitor of Bruton tyrosine kinase, which is overexpressed in the myeloma stem cell population. This study examined various doses of ibrutinib ± low‐dose dexamethasone in patients who received ≥2 prior lines of therapy, including an immunomodulatory agent. Daily ibrutinib ± weekly dexamethasone 40 mg was assessed in 4 cohorts using a Simon 2‐stage design. The primary objective was clinical benefit rate (CBR; ≥minimal response); secondary objectives included safety. Patients (n = 92) received a median of 4 prior regimens. Ibrutinib + dexamethasone produced the highest CBR (28%) in Cohort 4 (840 mg + dexamethasone; n = 43), with median duration of 9·2 months (range, 3·0–14·7). Progression‐free survival was 4·6 months (range, 0·4–17·3). Grade 3–4 haematological adverse events included anaemia (16%), thrombocytopenia (11%), and neutropenia (2%); grade 3–4 non‐haematological adverse events included pneumonia (7%), syncope (3%) and urinary tract infection (3%). Ibrutinib + dexamethasone produced notable responses in this heavily pre‐treated population. The encouraging efficacy, coupled with the favourable safety and tolerability profile of ibrutinib, supports its further evaluation as part of combination treatment.

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Section: Methodsmentioning

confidence: 99%

“…The primary end point of the study was CBR, defined as the proportion of patients achieving an MR or better as assessed by investigator per modified IMWG criteria (Durie et al , 2006; Anderson et al , 2008). The primary efficacy analysis was performed on the all‐treated population.…”

Section: Methodsmentioning

confidence: 99%

Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results

et al. 2018

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“…Key secondary endpoints included the overall response rate (ORR; defined as partial response or better), duration of response (DOR), overall survival (OS), time to second‐line anti‐myeloma therapy and safety. Progression and response were evaluated using the International Myeloma Working Group criteria (Durie et al , 2006) and reviewed by an independent response‐adjudication committee. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (National Cancer Institute, 2006).…”

Section: Methodsmentioning

confidence: 99%

Continuous treatment with lenalidomide and low‐dose dexamethasone in transplant‐ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial

Lee

Huang

et al. 2017

Br J Haematol

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SummaryThe phase 3 FIRST (Frontline Investigation of REVLIMID + Dexamethasone Versus Standard Thalidomide) trial demonstrated that lenalidomide plus low‐dose dexamethasone (Rd) until disease progression (Rd continuous) is an effective treatment option for transplant‐ineligible patients with newly diagnosed multiple myeloma (NDMM). Given genetic differences between Asian and Western populations, this subanalysis of the FIRST trial examined the safety and efficacy of Rd (given continuously or for 18 cycles [Rd18]) and MPT (melphalan, prednisone, thalidomide) in 114 Asian patients from Mainland China, South Korea and Taiwan. Efficacy and safety with Rd continuous in Asian patients were consistent with those in the overall study population. The overall response rates were 77·8% for Rd continuous, 57·5% for MPT and 65·8% for Rd18. The risk of progression or death was reduced by 39% with Rd continuous versus MPT and by 35% with Rd continuous versus Rd18. Rd continuous improved the 3‐year survival rate compared with MPT (70·2% vs. 56·4%) and Rd18 (58·1%). Common grade 3/4 adverse events in the Rd continuous and MPT arms were neutropenia (25·0% vs. 43·6%), infection (19·4% vs. 28·2%) and anaemia (19·4% vs. 15·4%), respectively. Thromboembolic event rates were low, and no second primary malignancies were observed. Rd continuous is safe and effective in transplant‐ineligible Asian patients with NDMM.

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“…Myeloma disease response was assessed by the individual investigators in accordance with IMWG uniform criteria (Durie et al , 2006). A single bone marrow assessment was performed to document complete responses (CRs).…”

Section: Methodsmentioning

confidence: 99%

A pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end‐stage renal disease requiring haemodialysis

et al. 2016

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SummaryRenal impairment (RI) is a major complication of multiple myeloma (MM). This study aimed to characterize the single‐dose pharmacokinetics (PK) of the oral proteasome inhibitor, ixazomib, in cancer patients with normal renal function [creatinine clearance (CrCl) ≥90 ml/min; n = 20), severe RI (CrCl <30 ml/min; n = 14), or end‐stage renal disease requiring haemodialysis (ESRD; n = 7). PK and adverse events (AEs) were assessed after a single 3 mg dose of ixazomib. Ixazomib was highly bound to plasma proteins (~99%) in all renal function groups. Unbound and total systemic exposures of ixazomib were 38% and 39% higher, respectively, in severe RI/ESRD patients versus patients with normal renal function. Total ixazomib concentrations were similar in pre‐ and post‐dialyser samples collected from ESRD patients; therefore, ixazomib can be administered without regard to haemodialysis timing. Except for anaemia, the incidence of the most common AEs was generally similar across groups, but grade 3 and 4 AEs were more frequent in the severe RI/ESRD groups versus the normal group (79%/57% vs. 45%), as were serious AEs (43%/43% vs. 15%). The PK and safety results support a reduced ixazomib dose of 3 mg in patients with severe RI/ESRD.

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International uniform response criteria for multiple myeloma

Cited by 2,364 publications

References 27 publications

Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results

Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results

Continuous treatment with lenalidomide and low‐dose dexamethasone in transplant‐ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial

A pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end‐stage renal disease requiring haemodialysis

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