Evidence map›Paper›PMID 34536308›Full record

Trial reportEuropean journal of haematology2022

Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group.

Henrik Gregersen, Valdas Peceliunas, Kari Remes, Fredrik Schjesvold, Niels Abildgaard, Hareth Nahi, Niels Frost Andersen, Annette Juul Vangsted, Tobias Wirenfeldt Klausen, Carsten Helleberg and 11 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in European journal of haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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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

21 authors.

Henrik GregersenDepartment of Haematology, Aalborg University Hospital, Aalborg, Denmark.
Valdas PeceliunasDepartment of Haematology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
Kari RemesDepartment of Haematology, Turku University Hospital, Turku, Finland.
Fredrik SchjesvoldOslo Myeloma Center, Oslo University Hospital, Oslo, Norway.ORCID https://orcid.org/0000-0003-1096-0569
Niels AbildgaardDepartment of Haematology, Odense University Hospital, Odense, Denmark.
Hareth NahiDepartment of Haematology, Karolinska University Hospital, Stockholm, Sweden.
Niels Frost AndersenDepartment of Haematology, Aarhus University Hospital, Aarhus, Denmark.
Annette Juul VangstedDepartment of Haematology, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-2131-731X
Tobias Wirenfeldt KlausenDepartment of Haematology, Herlev Hospital, Herlev, Denmark.
Carsten HellebergDepartment of Haematology, Herlev Hospital, Herlev, Denmark.
Kristina CarlsonDepartment of Haematology, Uppsala University Hospital, Uppsala, Sweden.
Ulf Christian FrølundDepartment of Haematology, Zealand University Hospital, Roskilde, Denmark.
Per AxelssonDepartment of Haematology, Helsingborg Hospital, Helsingborg, Sweden.
Olga StrombergDepartment of Haematology, Karolinska University Hospital, Stockholm, Sweden.
Cecilie Hveding BlimarkDepartment of Haematology, Sahlgrenska University Hospital, Göteborg, Sweden.ORCID https://orcid.org/0000-0003-3297-6019
Jacob CrafoordDepartment of Haematology, Örebro University Hospital, Örebro, Sweden.
Galina TsykunovaDepartment of Haematology, Haukeland University Hospital, Bergen, Norway.
Henrik Rode EshojQuality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark.
Anders WaageDepartment of Haematology, St Olavs hospital and Institute of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Markus HanssonDepartment of Haematology, Skåne University Hospital, Lund, Sweden.
Nina GulbrandsenOslo Myeloma Center, Oslo University Hospital, Oslo, Norway.

Funding

Amgen
6 · The paper itself

Abstract

objectiveWe investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma.

methodsThis randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 → 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86).

resultsMedian time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4-21.8) in the control group (HR 0.46, 95% CI 0.30-0.71; P = .0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections.

conclusionIn summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.

Indexed as

Hematopoietic Stem Cell TransplantationAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorClinical Decision-MakingDexamethasoneDisease ManagementDisease SusceptibilityFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultiple MyelomaOligopeptidesPrognosisBiomarkers, TumorcarfilzomibDexamethasoneOligopeptidescarfilzomibinduction chemotherapymaintenance chemotherapymultiple myelomasalvage therapy

Identifiers

PMID34536308
PMCPMC9292771

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Registered trials

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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.