Evidence map›Paper›PMID 21047977›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma.

George Somlo, Ricardo Spielberger, Paul Frankel, Chatchada Karanes, Amrita Krishnan, Pablo Parker, Leslie Popplewell, Firoozeh Sahebi, Neil Kogut, David Snyder and 4 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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.

NCT01665014 phase2unknown statusnot on this mapstarted 2012, after this paper: background citation

Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma

TypeinterventionalSponsorMaria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, GliwiceRan2012 to 2016Enrolled50ConditionsMultiple MyelomaArmsTotal marrow irradiation
NCT01794572 naterminatednot on this mapstarted 2013, after this paper: background citation

Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.

TypeinterventionalSponsorInstitut Cancerologie de l'OuestRan2013 to 2020Enrolled13ConditionsMultiple Myeloma in RelapseArmsTotal Bone Marrow Irradiation (TBMI) 8 Gy, Total Bone Marrow Irradiation (TBMI) 10 Gy, Total Bone Marrow Irradiation (TBMI): 12 Gy, Total Bone Marrow Irradiation (TBMI): 14 Gy, Total Bone Marrow Irradiation (TBMI): 16 Gy
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Multiple Myeloma, Version 2.2016: Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2015
    Guideline
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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

14 authors.

George SomloDepartments of Medical Oncology & Therapeutics Research, City of Hope Cancer Center, Duarte, California 91010, USA. gsomlo@coh.org
Ricardo Spielberger
Paul Frankel
Chatchada Karanes
Amrita Krishnan
Pablo Parker
Leslie Popplewell
Firoozeh Sahebi
Neil Kogut
David Snyder
An Liu
Timothy Schultheiss
Stephen Forman
Jeffrey Y C Wong

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
Vaccine-Induced Immunity to CMVP01CA030206 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI FORMAN, STEPHEN J · 1985 to 2010
$31.8M
RECOMBINANT ANTI-CEA ANTIBODIESP01CA043904 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI RAUBITSCHEK, ANDREW A. · 1988 to 2012
$30.2M
NCI NIH HHS P01 CA030206NCI NIH HHS P01 CA043904NCI NIH HHS P01 CA 30206-21NCI NIH HHS P30 CA033572NCI NIH HHS P30 CA 33572PHS HHS NCI 43904
6 · The paper itself

Abstract

purposeTo establish feasibility, maximum tolerated dose (MTD), and potential efficacy of ablative dose total marrow irradiation (TMI) delivered by helical tomotherapy in patients with multiple myeloma (MM). EXPERIMENTAL

designPatients with responding or stable MM received tandem autologous stem cell transplants, first with melphalan 200 mg/m(2), and 60 days or later with TMI. TMI doses were to be escalated from 1,000 cGy by increments of 200 cGy. All patients received thalidomide and dexamethasone maintenance.

resultsTwenty-two of 25 enrolled patients (79%) received tandem autologous stem cell transplantation (TASCT): TMI was administered at a median of 63.5 days (44-119) after melphalan. Dose-limiting toxicities at level 5 (1,800 cGy) included reversible grade 3 pneumonitis, congestive heart failure, and enteritis (1), and grade 3 hypotension (1). The estimated median radiation dose to normal organs was 11% to 81% of the prescribed marrow dose. Late toxicities included reversible enteritis (1), and lower extremity deep venous thrombosis during maintenance therapy (2). The complete and very good partial response rates were 55% and 27% following TASCT and maintenance therapy. At a median of 35 months of follow-up (21-50+ months), progression-free and overall survival for all patients were 49% (95% CI, 0.27-0.71) and 82% (0.67-1.00).

conclusionAblative dose TMI as part of TASCT is feasible, and the complete response rate is encouraging. Careful monitoring of late toxicities is needed. Further assessment of this modality is justified at the 1,600 cGy MTD level in MM patients who are candidates for ASCT.

Indexed as

Ablation TechniquesAdultAgedAntineoplastic AgentsBone MarrowCombined Modality TherapyDexamethasoneDose-Response Relationship, RadiationFemaleFollow-Up StudiesHumansMaleMaximum Tolerated DoseMiddle AgedMultiple MyelomaNeoplasm StagingAntineoplastic AgentsDexamethasoneThalidomide

Identifiers

PMID21047977
PMCPMC3717559

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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.