Evidence map›Paper›PMID 29954932›Full record

Trial reportHaematologica2018

A phase I/II dose-escalation study investigating all-oral ixazomib-melphalan-prednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma.

Jesús F San-Miguel, Maria-Asunción Echeveste Gutierrez, Ivan Špicka, María-Victoria Mateos, Kevin Song, Michael D Craig, Joan Bladé, Roman Hájek, Christine Chen, Alessandra Di Bacco and 6 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Haematologica, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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

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

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Moving Toward Continuous Therapy in Multiple Myeloma.Clinical hematology international · 2019
    Review
  6. 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

16 authors.

Jesús F San-MiguelClinica Universidad de Navarra, Centro Investigación Medica Aplicada (CIMA), El Instituto de Investigación Sanitaria de Navarra (IDISNA), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Pamplona, Spain sanmiguel@unav.es.
Maria-Asunción Echeveste GutierrezHospital Universitario Donostia, San Sebastián, Spain.
Ivan Špicka1Medical Department - Clinical Department of Haematology, First Faculty of Medicine and General Teaching Hospital, Charles University, Prague, Czech Republic.
María-Victoria MateosHospital Universitario de Salamanca, Instituto Biosanitario de Salamanca (IBSAL), Spain.
Kevin SongDivision of Hematology, University of British Columbia, Vancouver, BC, Canada.
Michael D CraigDepartment of Medicine, West Virginia University, Morgantown, WV, USA.
Joan BladéDepartment of Hematology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain.
Roman HájekDepartment of Haematooncology, University Hospital Ostrava, Faculty of Medicine, Ostrava University, Czech Republic.
Christine ChenCancer Clinical Research Unit, Princess Margaret Cancer Center, Toronto, ON, Canada.
Alessandra Di BaccoMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Jose EstevamMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Neeraj GuptaMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Catriona ByrneMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Vickie LuMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Helgi van de VeldeMillennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Atlanta, GA, USA.
Sagar LonialWinship Cancer Institute of Emory University, Atlanta, GA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase I/II dose-escalation study investigated the all-oral ixazomib-melphalan-prednisone regimen, followed by single-agent ixazomib maintenance, in elderly, transplant-ineligible patients with newly diagnosed multiple myeloma. Primary phase I objectives were to determine the safety and recommended phase II dose of ixazomib-melphalan-prednisone. The primary phase II objective was to determine the complete plus very good partial response rate. In phase I, patients were enrolled to 4 arms investigating weekly or twice-weekly ixazomib (13 28-day cycles or nine 42-day cycles) plus melphalan-prednisone. In phase II, an expansion cohort was enrolled at the recommended phase II ixazomib dose. Of the 61 patients enrolled, 26 received the recommended phase II dose (ixazomib 4.0 mg [days 1, 8, 15] plus melphalan-prednisone 60 mg/m

Indexed as

Administration, OralAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsFemaleGlycineHumansInduction ChemotherapyKaplan-Meier EstimateMaintenance ChemotherapyMaleMelphalanMiddle AgedMultiple MyelomaNeoplasm MetastasisBoron CompoundsGlycineixazomibMelphalanPrednisone

Identifiers

PMID29954932
PMCPMC6119151

What OpenQuestion holds

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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.