Evidence map›Paper›PMID 27088375›Full record

Trial reportBone marrow transplantation2016

A phase II, single-arm, prospective study of bendamustine plus melphalan conditioning for second autologous stem cell transplantation in de novo multiple myeloma patients through a tandem transplant strategy.

M Martino, G Tripepi, G Messina, I D Vincelli, G Console, A G Recchia, M Gentile, S Molica, F Morabito

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Optimizing high dose melphalan.Blood reviews · 2024
    Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Bendamustine with Total Body Irradiation Limits Murine Graft-versus-Host Disease in Part Through Effects on Myeloid-Derived Suppressor Cells.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Article
  16. Article
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.

M MartinoHematology and Stem Cell Transplantation Unit, Onco-Hematology Department, Azienda Ospedaliera 'BMM', Reggio Calabria, Italy.
G TripepiNational Research Council (CNR), Institute of Clinical Physiology, Reggio Calabria, Italy.
G MessinaHematology and Stem Cell Transplantation Unit, Onco-Hematology Department, Azienda Ospedaliera 'BMM', Reggio Calabria, Italy.
I D VincelliHematology, Onco-Hematology Department, Azienda Ospedaliera 'BMM', Reggio Calabria, Italy.
G ConsoleHematology and Stem Cell Transplantation Unit, Onco-Hematology Department, Azienda Ospedaliera 'BMM', Reggio Calabria, Italy.
A G RecchiaBiotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano (CS), Italy.
M GentileHaematology Unit, Azienda Ospedaliera Cosenza, Cosenza, Italy.
S MolicaHaematology Unit, Azienda Ospedaliera 'Pugliese-Ciaccio' Catanzaro, Catanzaro, Italy.
F MorabitoBiotechnology Research Unit, Azienda Sanitaria Provinciale di Cosenza, Aprigliano (CS), Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II trial evaluates, for the first time, the safety and efficacy of bendamustine plus high-dose melphalan (HDM) as a conditioning regimen before the second autologous stem cell transplantation (ASCT) in previously untreated multiple myeloma (MM) patients. In total, 32 ASCT patients received HDM (200 mg/m(2)) as conditioning for the first ASCT. After 3-6 months from the first ASCT, responding patients underwent a second ASCT following bendamustine (200 mg/m(2)) and HDM (140 mg/m(2)). High-dose chemotherapy and ASCT were performed with complete neutrophil and platelet recovery in all patients. The median number of days to neutrophil and platelet engraftment was 11 (range 9-15) and 12 (range 10-19), respectively. Only one subject experienced grade 3 diarrhea; the rate of mucositis and vomiting was significantly lower with the bendamustine plus HDM regimen compared with the HDM-only regimen (81.2 vs 96.9%, P=0.025 and 78.1 vs 100%, P=0.008). Overall response rate (ORR) was 81.2% after the first transplant, and 90.6% after the second, while complete response rates were 46.8 and 62.5%, respectively (P=0.016). Actuarial 2-year PFS and OS were 79% (95% confidence interval (CI), 60-98) and 97% (95% CI, 91-100), respectively. Bendamustine+HDM is feasible as the conditioning regimen for second ASCT in MM patients. The present study may pave the way for phase III studies specifically aimed at further investigating this combination strategy. The role of this combination in MM for conditioning regimen in a first or single ASCT setting should be also investigated.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDiarrheaFemaleGraft SurvivalHematopoietic Stem Cell TransplantationHumansMaleMelphalanMiddle AgedMucositisMultiple MyelomaTransplantation ConditioningTreatment OutcomeBendamustine HydrochlorideMelphalan

Identifiers

PMID27088375

What OpenQuestion holds

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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.