Evidence map›Paper›PMID 24429497›Full record

Trial reportLeukemia2014

Replacement of bortezomib with carfilzomib for multiple myeloma patients progressing from bortezomib combination therapy.

J R Berenson, J D Hilger, O Yellin, R Dichmann, D Patel-Donnelly, R V Boccia, A Bessudo, L Stampleman, D Gravenor, S Eshaghian and 3 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing 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.

NCT01365559 phase1 / phase2completednot on this map

A Phase I/II Study of Carfilzomib as a Replacement for Multiple Myeloma Patients Failing Bortezomib-containing Regimens

TypeinterventionalSponsorOncotherapeuticsRan2011 to 2016Enrolled39ConditionsMultiple MyelomaArmsGroup A: Carfilzomib & Non-IMiD Regimen, Group B: Carfilzomib & IMiD containing regimen.
NCT03909412 phase1recruitingnot on this mapstarted 2019, after this paper: background citation

Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma

TypeinterventionalSponsorHackensack Meridian HealthRan2019 to 2026Enrolled18ConditionsMultiple MyelomaArmsCarfilzomib, Cyclophosphamide, Dexamethasone, Granulocyte Colony-Stimulating Factor
3 · Its place in the literature

Who cites it

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

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  6. Nanomedicine-Based Strategies for Multiple Myeloma Therapy.International journal of nanomedicine · 2026
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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

13 authors.

J R Berenson1] Department of Hematology/Oncology, Institute for Myeloma and Bone Cancer Research, West Hollywood, CA, USA [2] Oncotherapeutics, West Hollywood, CA, USA [3] James R Berenson, MD, Inc., West Hollywood, CA, USA.
J D HilgerOncotherapeutics, West Hollywood, CA, USA.
O YellinOncotherapeutics, West Hollywood, CA, USA.
R DichmannDepartment of Medical Oncology and Hematology, Central Coast Medical Oncology, Santa Maria, CA, USA.
D Patel-DonnellyDepartment of Hematology, Fairfax Northern Virginia Hematology Oncology, Fairfax, VA, USA.
R V BocciaCenter for Cancer and Blood Disorders, Bethesda, MD, USA.
A BessudoDepartment of Medical Oncology and Hematology, California Cancer Associates for Research and Excellence, Encinitas, CA, USA.
L StamplemanPacific Cancer Care, Department of Medical Oncology & Hematology, Monterey, CA, USA.
D GravenorOncology Family Cancer Center Foundation, Memphis, TN, USA.
S EshaghianDepartment of Internal Medicine, Hematology, and Oncology, Cedars-Sinai Medical Center, Los Angeles, USA.
Y NassirCancer Care Institute, Los Angeles, CA, USA.
R A SwiftJames R Berenson, MD, Inc., West Hollywood, CA, USA.
R A VescioDepartment of Internal Medicine, Hematology, and Oncology, Cedars-Sinai Medical Center, Los Angeles, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this open-label, intra-patient phase I/II trial, bortezomib was replaced with carfilzomib (escalated from 20 to 45 mg/m(2) on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle) for multiple myeloma (MM) patients who progressed while on or within 12 weeks of receiving a bortezomib-containing combination regimen. Study objectives included determination of the maximum tolerated dose (MTD), overall response rate (ORR), clinical benefit rate (CBR), time to progression, time to response, duration of response, progression-free survival and overall survival (OS). Of 38 registered patients, 37 were treated and evaluable for efficacy and safety. Thirty-one carfilzomib-based regimens using 14 different drug combinations were tested. One regimen (carfilzomib (45 mg/m(2)), ascorbic acid (1000 mg) and cyclophosphamide (2.2 mg/kg)) reached MTD. ORR and CBR were 43.2 and 62.2%, respectively. Median progression-free survival, time to progression and OS were 8.3, 9.9 and 15.8 months, respectively. Hematologic adverse events (AEs; ⩾grade 3) included lymphopenia (35.1%), thrombocytopenia (24.3%), anemia (10.8%) and neutropenia (10.8%). Nonhematologic AEs (⩾grade 3) included fever (5.4%) and hypokalemia (5.4%). These results demonstrate that replacing bortezomib with carfilzomib is safe and can be effective for MM patients failing bortezomib-containing combination regimens. This trial was registered at http://www.clinicaltrials.gov (#NCT01365559).

Indexed as

AgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibDrug SubstitutionFemaleHumansMaleMiddle AgedMultiple MyelomaNeoplasm StagingOligopeptidesPyrazinesTreatment OutcomeAntineoplastic AgentsBoronic AcidsBortezomibcarfilzomibOligopeptidesPyrazines

Identifiers

PMID24429497

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.