Carfilzomib weekly 20/56mg/m², lenalidomide and dexamethasone for early relapsed refractory multiple myeloma.

Richez, Valentine; Guidez, Stéphanie; Azaïs, I.; Durand, G.; Javaugue, Vincent; Brigaud, Antoine; Machet, Antoine; Moya, Niels; Gruchet, Cécile; Bobin, Arthur; Levy, Ayelet; Sabirou, Florence; Diéval, C.; Fleck, Emmanuel; Princet, Isabelle; Bauwens, Delphine; Fouquet, Guillemette; Bridoux, Frank; Avet‐Loiseau, Hervé; Leleu, Xavier

doi:10.1200/jco.2018.36.15_suppl.8017

JCO

2018

DOI: 10.1200/jco.2018.36.15_suppl.8017

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Carfilzomib weekly 20/56mg/m², lenalidomide and dexamethasone for early relapsed refractory multiple myeloma.

Valentine Richez

Stéphanie Guidez

I. Azaïs

et al.

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“…Champion study (14) and the randomised phase 3 Arrow study (17), in the relapse setting associated 254 with lenalidomide and dexamethasone (18), or upfront associated with melphalan and prednisone in 255 eNDMM in this IFM2012-03 study. It is thus likely that independently of the regimen used, 256 carfilzomib will be used weekly in future studies.…”

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Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial

Leleu

Fouquet

Richez³

et al. 2019

Clinical Cancer Research

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Purpose: Carfilzomib is a novel generation proteasome inhibitor. The Carmysap trial demonstrated that twice-weekly KMP (carfilzomib, melphalan, prednisone) might challenge the MPV (melphalan, prednisone, bortezomib) standard. We sought to study KMP weekly, allowing to increase carfilzomib's dose with maintained efficacy and improved safety profile. Patients and Methods: IFM2012-03, a phase I multicenter study of KMP weekly in elderly patients with newly diagnosed multiple myeloma (eNDMM), aimed to determine the MTD of carfilzomib. Carfilzomib was given intravenously at 36, 45, 56, and 70 mg/m2/day on days 1, 8, 15, and 22 with melphalan and prednisone, for nine 35-day induction cycles, followed by carfilzomib maintenance for 1 year. Three dose-limiting toxicities (DLT) determined MTD at the lower dose. Results: Thirty eNDMMs were treated, 6 per cohort at 36, 45, and 56 mg/m2 and 12 at 70 mg/m². There was one DLT at 36 mg/m2 (lymphopenia), one at 45 mg/m2 (lysis syndrome), two at 56 mg/m2 (cardiac insufficiency and febrile neutropenia), and two at 70 mg/m2 (vomiting and elevated liver enzymes). The safety profile was acceptable; however, specific attention must be paid to the risk of cardiovascular events, especially for elderly patients. The overall response rate was 93.3%, with 46.6% complete response. Conclusions: The MTD dose of carfilzomib was 70 mg/m2 in this KMP weekly study in eNDMM. Response rates, and especially CR rate, were remarkable in this population, and would benefit from being assessed in a larger-scale study. The IFM2012-03 study demonstrated that the MTD of carfilzomib weekly is 70 mg/m2 in eNDMM, and 56 mg/m2 for patients older than 75 years. Carfilzomib used weekly in combination has a good efficacy and safety profile in eNDMM.

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Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial

Leleu

Fouquet

Richez³

et al. 2019

Clinical Cancer Research

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Double-drug loading upconversion nanoparticles for monitoring and therapy of a MYC/BCL6-positive double-hit diffuse large B-cell lymphoma

et al. 2022

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Carfilzomib weekly 20/56mg/m², lenalidomide and dexamethasone for early relapsed refractory multiple myeloma.

Cited by 2 publications

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Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial

Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial

Double-drug loading upconversion nanoparticles for monitoring and therapy of a MYC/BCL6-positive double-hit diffuse large B-cell lymphoma

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