Evidence map›Paper›PMID 29615082›Full record

Trial reportJournal of hematology & oncology2018

Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study.

Meletios Dimopoulos, Michael Wang, Vladimir Maisnar, Jiri Minarik, William Bensinger, Maria-Victoria Mateos, Mihaela Obreja, Julie Blaedel, Philippe Moreau

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of hematology & oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01080391 (A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

NCT01080391 phase3completednot on this map

A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

TypeinterventionalSponsorAmgenRan2010 to 2017Enrolled792ConditionsRelapsed Multiple MyelomaArmsDexamethasone, Lenalidomide, Carfilzomib
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Multiple Myeloma in 2023 Ways: From Trials to Real Life.Current oncology (Toronto, Ont.) · 2023
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review
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

9 authors.

Meletios DimopoulosSchool of Medicine, National and Kapodistrian University of Athens, Athens, Greece. mdimop@med.uoa.gr.ORCID 0000-0001-8990-3254
Michael WangThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Vladimir MaisnarFaculty Hospital and Medical Faculty of Charles University in Hradec Kralove, Hradec Kralove, Czech Republic.
Jiri MinarikUniversity Hospital Olomouc, Medical Faculty of Palacky University Olomouc, Olomouc, Czech Republic.
William BensingerFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Maria-Victoria MateosHospital Clinico Universitario de Salamanca-IBSAL, Salamanca, Spain.
Mihaela ObrejaAmgen, Inc., Thousand Oaks, CA, USA.
Julie BlaedelAmgen, Inc., Thousand Oaks, CA, USA.
Philippe MoreauUniversity of Nantes, Nantes, France.

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

backgroundIn ASPIRE, carfilzomib, lenalidomide, and dexamethasone (KRd) significantly improved progression-free survival (PFS) and response rates versus lenalidomide and dexamethasone (Rd) in patients with relapsed multiple myeloma. Per protocol, patients received KRd for a maximum of 18 cycles followed by Rd to progression, so the benefit/risk profile of KRd to progression was not established.

methodsThis post hoc analysis evaluated the efficacy and safety of KRd versus Rd at 18 months from randomization. Cumulative rates of complete response (CR) or better over time and PFS hazard ratio (HR) at 18 months were evaluated for KRd versus Rd. PFS HRs were also assessed according to cytogenetic risk, prior lines of therapy, and prior bortezomib treatment. Cox regression analysis was used to evaluate PFS HRs.

resultsThe hazard ratio (HR) for PFS at 18 months was 0.58 versus 0.69 for the overall ASPIRE study. Patients with high-risk cytogenetics, ≥ 1 prior lines of therapy, and prior bortezomib exposure benefited from KRd up to 18 months versus Rd. The HRs for PFS at 18 months in the pre-defined subgroups were lower than those in the overall study. The difference in the proportion of KRd and Rd patients achieving at least a complete response (CR) increased dramatically over the first 18 months and then remained relatively constant. The safety profile at 18 months was consistent with previous findings.

conclusionsThe improved PFS HR at 18 months and the continued increase in CR rates for KRd through 18 cycles suggest that there may be a benefit of continued carfilzomib treatment.

trial registrationClinical trials.gov NCT01080391 . Registered 2 March 2010.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleHumansLenalidomideMaleMultiple MyelomaOligopeptidesProgression-Free SurvivalRecurrencecarfilzomibDexamethasoneLenalidomideOligopeptidesClinical researchClinical trialsMultiple myelomaMyeloma therapy

Identifiers

PMID29615082
PMCPMC5883881

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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.