CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma

Berenson, James R.; Cartmell, Alan; Bessudo, Alberto; Lyons, Roger M.; Harb, Wael A.; Tzachanis, Dimitrios; Agajanian, Richy; Boccia, Ralph V.; Coleman, Morton; Moss, Robert A.; Rifkin, Robert M.; Patel, Priti; Dixon, Sandra; Ou, Ying; Anderl, Janet L.; Aggarwal, Sanjay; Berdeja, Jesús G.

doi:10.1182/blood-2015-11-683854

Cited by 91 publications

(98 citation statements)

References 24 publications

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“…OS analysis showed that the carfilzomib/dexamethasone group lived 7.6 months longer (median OS, 47.6 months for carfilzomib vs 40 for bortezomib; HR, 0.791; 95% CI, 0.648-0.964; P=.010). 29 A phase II study in patients with R/R MM (n=104) evaluated safety and efficacy of weekly dosing 30 of carfilzomib (70 mg/m 2 ) with dexamethasone. 31 The observed ORR was 77% (95% CI, 68- 31 Based on the data from the ENDEAVOR trial, the NCCN MM Panel included the combination of carfilzomib (twice weekly) and dexamethasone as a category 1, preferred option for patients with R/R MM.…”

Section: Updates To Maintenance Therapy Recommendationsmentioning

confidence: 99%

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

Kumar¹,

Callander²,

Alsina³

et al. 2018

J Natl Compr Canc Netw

148

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The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, evaluation, treatment, including supportivecare, and follow-up for patients with myeloma. These NCCN Guidelines Insights highlight the important updates/changes specific to the myeloma therapy options in the 2018 version of the NCCN Guidelines. J Natl Compr Canc Netw 2018;16(1):11-20 doi: 10.6004/jnccn.2018.0002 © JNCCN-Journal of the National Comprehensive Cancer Network | NCCN: Continuing EducationTarget Audience: This activity is designed to meet the educational needs of physicians, nurses, and pharmacists involved in the management of patients with cancer.

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Section: Updates To Maintenance Therapy Recommendationsmentioning

confidence: 99%

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

Kumar¹,

Callander²,

Alsina³

et al. 2018

J Natl Compr Canc Netw

148

View full text Add to dashboard Cite

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“…Recently, a phase 1/2 study (CHAMPION‐1) in the USA evaluated weekly Cd in relapsed or refractory MM (RRMM) patients . In that study, the overall response rate (ORR) at 70 mg/m 2 was 77%, and the median PFS was 12.6 months, indicating that further assessment of the weekly dosing was warranted.…”

Section: Introductionmentioning

confidence: 99%

Weekly carfilzomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma: A phase 1 and PK/PD trial

et al. 2018

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This open‐label multicenter phase 1 study evaluated the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of weekly carfilzomib and dexamethasone (Cd) in Japanese patients with relapsed or refractory multiple myeloma (RRMM). Carfilzomib was administered by 30‐minute intravenous infusion on Days 1, 8 and 15 in a 28‐day cycle starting at 20 mg/m2 on Day 1/Cycle 1 and 70 mg/m2 thereafter until progressive disease or unacceptable toxicity. Dexamethasone 40 mg was administered on Days 1, 8, 15 and 22 in Cycles 1‐9 and on Days 1, 8 and 15 thereafter. Six patients were enrolled between March 2015 and June 2015. Patients had received a median of 4.5 (range, 4‐8) prior regimens; all patients had previous therapies with bortezomib and immunomodulatory drugs. Of the 6 patients, 1 had a dose‐limiting toxicity (DLT), and tolerability was confirmed. The DLT was grade 3 thrombotic microangiopathy, which was considered serious and occurred on Day 11/Cycle 1. All 6 patients (100%) experienced at least 1 grade ≥3 adverse event (AE). Two patients (33.3%) experienced AE (also considered adverse drug reactions) leading to study discontinuation: thrombotic microangiopathy (Day 11/Cycle 1) and thrombotic thrombocytopenic purpura (Day 6/Cycle 2). The overall response rate was 83.3% (95% confidence interval, 43.6‐97.0). The weekly Cd regimen at a carfilzomib dose of 20/70 mg/m2 was well‐tolerated among Japanese patients with RRMM. Our results could be the basis for the further development of carfilzomib treatment considering safety profiles including microangiopathy‐related events and efficacy.

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“…Of note, the phase I/II CHAMPION-1 trial evaluated the more convenient weekly administration of carfilzomib, at a higher dose of 70 mg/m 2 in combination with dexamethasone, and showed promising response rates and PFS that merit additional evaluation. 32 Recently, Vd was compared with Vd plus daratumumab (DVd) in relapsed MM (CASTOR trial), and the triplet combination was associated with an impressive PFS improvement (HR: 0.39). 33 The benefit of the addition of daratumumab was observed across all subgroups of patients, including those with all the characteristics of patient 4: first relapse, prior IMiD, and .65 years of age.…”

Section: Comments On Patientmentioning

confidence: 99%

How I treat myeloma with new agents

Moreau

2017

Blood

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At present, multiple classes of agents with distinct mechanisms of action are available for the treatment of patients with multiple myeloma (MM), including alkylators, steroids, immunomodulatory agents (IMiDs), proteasome inhibitors (PIs), histone deacetylase inhibitors (DACIs), and monoclonal antibodies (mAbs). Over the last 5 years, several new agents, such as the third-generation IMiD pomalidomide, the second-generation PIs carfilzomib and ixazomib, the DACI panobinostat, and 2 mAbs, elotuzumab and daratumumab, have been approved, incorporated into clinical guidelines, and have transformed our approach to the treatment of patients. These agents may be part of doublet or triplet combinations, or incorporated into intensive strategies with autologous stem cell transplantation. In this review, I discuss the different treatment options available today for the treatment of MM in frontline and relapse settings.

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CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma

Cited by 91 publications

References 24 publications

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018

Weekly carfilzomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma: A phase 1 and PK/PD trial

How I treat myeloma with new agents

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