Evidence map›Paper›PMID 25710456›Full record

Trial reportHaematologica2015

Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma.

Jesus G Berdeja, Lowell L Hart, Joseph R Mace, Edward R Arrowsmith, James H Essell, Rami S Owera, John D Hainsworth, Ian W Flinn

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01496118 (Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma), which is not on this map. Cited by 45 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 6 pooled it
9.7field-weighted citation impact, top 2% of its field
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.

NCT01496118 phase1 / phase2completednot on this map

Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

TypeinterventionalSponsorSCRI Development Innovations, LLCRan2011 to 2020Enrolled80ConditionsMultiple MyelomaArmspanobinostat, carfilzomib
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 6 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. NCCN Guidelines Insights: Multiple Myeloma, Version 3.2016.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Guideline
  7. Trial
  8. Review
  9. Review
  10. Biology and Therapeutic Properties of Mesenchymal Stem Cells in Leukemia.International journal of molecular sciences · 2024
    Review
  11. Article
  12. Article
  13. Regulation of Malignant Myeloid Leukemia by Mesenchymal Stem Cells.Frontiers in cell and developmental biology · 2022
    Review
  14. Review
  15. Myeloma Bone Disease: A Comprehensive Review.International journal of molecular sciences · 2021
    Review
  16. Review
  17. Article
  18. Article
  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

8 authors at 4 institutions in 1 country.

Jesus G BerdejaSarah Cannon Research Institute, Nashville, TN Tennessee Oncology PLLC, Nashville, TN jberdeja@tnonc.com.
Lowell L HartSarah Cannon Research Institute, Nashville, TN Florida Cancer Specialists, Ft Myers, FL.
Joseph R MaceSarah Cannon Research Institute, Nashville, TN Florida Cancer Specialists, Ft Myers, FL.
Edward R ArrowsmithSarah Cannon Research Institute, Nashville, TN Tennessee Oncology PLLC, Nashville, TN.
James H EssellOncology Hematology Care, Cincinnati, OH.
Rami S OweraWoodlands Medical Specialists, Pensacola, FL, USA.
John D HainsworthSarah Cannon Research Institute, Nashville, TN Tennessee Oncology PLLC, Nashville, TN.
Ian W FlinnSarah Cannon Research Institute, Nashville, TN Tennessee Oncology PLLC, Nashville, TN.
Tennessee Oncology · USSarah Cannon · USFlorida Cancer Specialists & Research Institute · USOncology Hematology Care · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to assess the safety and efficacy of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma. Patients with multiple myeloma who had relapsed after at least one prior treatment were eligible to participate. In the dose escalation part of the study a standard 3+3 design was used to determine the maximum tolerated dose of four planned dose levels of the combination of carfilzomib and panobinostat. Panobinostat was administered on days 1, 3, 5, 15, 17, and 19. Carfilzomib was administered on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. Treatment was continued until progression or intolerable toxicity. Forty-four patients were accrued into the trial, 13 in the phase I part and 31 in the phase II part of the study. The median age of the patients was 66 years and the median number of prior therapies was five. The expansion dose was established as 30 mg panobinostat, 20/45 mg/m(2) carfilzomib. The overall response rate was 67% for all patients, 67% for patients refractory to prior proteasome inhibitor treatment and 75% for patients refractory to prior immune modulating drug treatment. At a median follow up of 17 months, median progression-free survival was 7.7 months, median time to progression was 7.7 months, and median overall survival had not been reached. The regimen was well tolerated, although there were several panobinostat dose reductions. In conclusion, the combination of panobinostat and carfilzomib is feasible and effective in patients with relapsed/refractory multiple myeloma. (Trial registered at ClinicalTrials.gov: NCT01496118).

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansHydroxamic AcidsIndolesMaleMiddle AgedMultiple MyelomaNeoplasm GradingNeoplasm Recurrence, LocalNeoplasm StagingOligopeptidesPanobinostatcarfilzomibHydroxamic AcidsIndolesOligopeptidesPanobinostat

Identifiers

PMID25710456
PMCPMC4420216
OpenAlexW2070814954

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.