Evidence map›Paper›PMID 30910541›Full record

Trial reportThe Lancet. Haematology2019

Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial.

Qaiser Bashir, Peter F Thall, Denái R Milton, Patricia S Fox, Jitesh D Kawedia, Partow Kebriaei, Nina Shah, Krina Patel, Borje S Andersson, Yago L Nieto and 17 more

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
8.0field-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.

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

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Transplant in myeloma: who, when, and why?Hematology. American Society of Hematology. Education Program · 2024
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Optimizing high dose melphalan.Blood reviews · 2024
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Haematologica · 2023
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  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

27 authors at 2 institutions in 1 country.

Qaiser BashirDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA. Electronic address: qbashir@mdanderson.org.
Peter F ThallDepartment of Biostatistics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Denái R MiltonDepartment of Biostatistics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Patricia S FoxDepartment of Biostatistics, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Jitesh D KawediaDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Partow KebriaeiDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Nina ShahDepartment of Hematology and Blood and Marrow Transplant, University of California San Francisco, San Francisco, CA, USA.
Krina PatelDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Borje S AnderssonDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Yago L NietoDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Ben C ValdezDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Simrit ParmarDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Gabriela RondonDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Ruby DelgadoDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Chitra HosingDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Uday R PopatDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Betul OranDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Stefan O CiureaDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Pei LinDepartment of Hematopathology, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Donna M WeberDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Sheeba K ThomasDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Hans C LeeDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Elisabet E ManasanchDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Robert Z OrlowskiDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Loretta A WilliamsDepartment of Symptom Research, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Richard E ChamplinDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Muzaffar H QazilbashDepartment of Stem Cell Transplantation & Cellular Therapy, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
The University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundRetrospective studies suggest that conditioning therapy with busulfan plus melphalan could result in longer progression-free survival compared with melphalan alone in patients with multiple myeloma undergoing autologous haemopoietic cell transplantation (auto-HCT). We aimed to test this hypothesis in a randomised trial.

methodsThe primary objective of the study was to compare progression-free survival with conditioning of busulfan plus melphalan with melphalan alone in patients with multiple myeloma. Patients with newly diagnosed multiple myeloma who were eligible for cell transplantation, aged 70 years or younger, with at least stable disease, were randomly assigned (1:1) to treatment. Patients received either busulfan plus melphalan, with a test dose of busulfan 32 mg/m

findingsBetween Oct 12, 2011, and March 22, 2017, 205 patients were assessed for eligibility and randomly assigned to treatment. The primary analysis of progression-free survival was measured in 202 patients who received treatment: 104 patients in the busulfan plus melphalan group and 98 patients in the melphalan alone group. 90 days after auto-HCT, 102 (98%) of 104 patients given busulfan plus melphalan and 95 (97%) of 98 patients given melphalan alone achieved partial response or better. The median follow-up in the busulfan plus melphalan group was 22·6 months (IQR 15·2-47·1) and 20·2 months (IQR 8·8-46·6) in the melphalan alone group. Median progression-free survival was 64·7 months (32·9-64·7) with busulfan plus melphalan versus 43·5 months (19·9-not estimated) with melphalan alone (hazard ratio 0·53 [95% CI 0·30-0·91]; p=0·022). There were no treatment-related deaths by day 100 in either group. Grade 2-3 mucositis was observed in 77 (74%) of 104 patients in the busulfan plus melphalan group versus 14 (14%) of 98 patients in the melphalan alone group.

interpretationThese findings, if confirmed in other ongoing studies, suggest that busulfan plus melphalan could replace melphalan alone as the conditioning regimen for auto-HCT in patients with newly diagnosed myeloma.

fundingThis study was funded in part by the National Institutes of Health (NIH) through MD Anderson's Cancer Center Support Grant (CA016672).

Indexed as

Hematopoietic Stem Cell TransplantationTransplantation ConditioningAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBusulfanFemaleHumansKaplan-Meier EstimateMaleMelphalanMiddle AgedMultiple MyelomaNeoplasm GradingTransplantation, AutologousTreatment OutcomeBusulfanMelphalan

Identifiers

PMID30910541
PMCPMC9446704
OpenAlexW2940396472

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.