Evidence map›Paper›PMID 27207788›Full record

Trial reportBlood2016

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

James R Berenson, Alan Cartmell, Alberto Bessudo, Roger M Lyons, Wael Harb, Dimitrios Tzachanis, Richy Agajanian, Ralph Boccia, Morton Coleman, Robert A Moss and 7 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01677858 phase1 / phase2completednot on this map

A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma

TypeinterventionalSponsorAmgenRan2012 to 2018Enrolled116ConditionsMultiple MyelomaArmsCarfilzomib, Dexamethasone
NCT03336073 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Carfilzomib and Dexamethasone in Combination With Cyclophosphamide vs. Carfilzomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma: a Phase II Randomized Controlled Trial

TypeinterventionalSponsorPETHEMA FoundationRan2017 to 2024Enrolled199ConditionsMultiple MyelomaArmsCarfilzomib, Dexamethasone, cyclophosphamide
NCT05060627 phase1 / phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

An Open Label, Multicenter, Phase I/II Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide.

TypeinterventionalSponsorPETHEMA FoundationRan2021 to 2028Enrolled60ConditionsRelapsed Multiple MyelomaArmsBelantamab mafodotin, Carfilzomib, Dexamethasone
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Low-dose versus High-dose Carfilzomib with Dexamethasone (S1304) in Patients with Relapsed-Refractory Multiple Myeloma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  12. Once-weeklyHaematologica · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

James R BerensonInstitute for Myeloma and Bone Cancer Research, West Hollywood, CA;
Alan CartmellComprehensive Blood and Cancer Center, Bakersfield, CA;
Alberto BessudoCancer Care Associates for Research and Excellence, Encinitas, CA;
Roger M LyonsUS Oncology Research and Cancer Care Centers of South Texas, San Antonio, TX;
Wael HarbHorizon Oncology Center, Lafayette, IN;
Dimitrios TzachanisCedars-Sinai Medical Center, Los Angeles, CA;
Richy AgajanianThe Oncology Institute of Hope and Innovation, Downey, CA;
Ralph BocciaCenter for Cancer and Blood Disorders, Bethesda, MD;
Morton ColemanDepartment of Hematology/Oncology, Weill Cornell Medical College, Clinical Research Alliance, New Hyde Park, NY;
Robert A MossRobert A. Moss Medical Oncology and Hematology, Fountain Valley, CA;
Robert M RifkinUS Oncology Research and Rocky Mountain Cancer Centers, Denver, CO;
Priti PatelOnyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA; and.
Sandra DixonOnyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA; and.
Ying OuOnyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA; and.
Janet AnderlOnyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA; and.
Sanjay AggarwalOnyx Pharmaceuticals, Inc., an Amgen subsidiary, South San Francisco, CA; and.
Jesus G BerdejaSarah Cannon Research Institute, Nashville, TN.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Carfilzomib, a proteasome inhibitor, is approved in the United States as a single agent, and in combination with dexamethasone or lenalidomide/dexamethasone (KRd) for relapsed or refractory multiple myeloma (MM). Under the single-agent and KRd approvals, carfilzomib is administered as a 10-minute IV infusion on days 1, 2, 8, 9, 15, and 16 of 28-day cycles (20 mg/m(2) [cycle 1, days 1-2]; 27 mg/m(2) thereafter). This multicenter, single-arm, phase 1/2 study, Community Harmonized Assessment of Myeloma Patients via an Integrated Oncology Network-1 (CHAMPION-1), evaluated once-weekly carfilzomib with dexamethasone in relapsed, or relapsed and refractory MM (1-3 prior therapies). Patients received carfilzomib (30-minute IV infusion) on days 1, 8, and 15 of 28-day cycles. The phase 1 portion used a 3 + 3 dose-escalation scheme to determine the maximum tolerated dose (MTD) of carfilzomib. During phase 2, patients received carfilzomib on the same schedule at the MTD. Patients received dexamethasone (40 mg) on days 1, 8, 15, and 22; dexamethasone was omitted on day 22 for cycles 9+. A total of 116 patients were enrolled. The MTD was 70 mg/m(2), and 104 patients (phase 1/2) received carfilzomib 70 mg/m(2) At 70 mg/m(2), the median number of prior regimens was 1; and 52% were bortezomib-refractory. At 70 mg/m(2), the most common grade ≥3 adverse events were fatigue (11%) and hypertension (7%). Overall response rate at 70 mg/m(2) was 77%. Median progression-free survival was 12.6 months. These findings merit additional evaluation of the once-weekly dosing regimen. This trial was registered at www.clinicaltrials.gov as #NCT01677858.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDisease-Free SurvivalFemaleHumansInfusions, IntravenousMaleMiddle AgedMultiple MyelomaOligopeptidesRecurrenceSurvival RatecarfilzomibDexamethasoneOligopeptides

Identifiers

PMID27207788
PMCPMC4929927

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.