Evidence map›Paper›PMID 31484647›Full record

Trial reportBlood2019

Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplant in multiple myeloma.

Laura Rosiñol, Albert Oriol, Rafael Rios, Anna Sureda, María Jesús Blanchard, Miguel Teodoro Hernández, Rafael Martínez-Martínez, Jose M Moraleda, Isidro Jarque, Juan Bargay and 16 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 125 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 9 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.

NCT01916252 phase3completednot on this map

A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma

TypeinterventionalSponsorPETHEMA FoundationRan2013 to 2016Enrolled460ConditionsMultiple MyelomaArmsbortezomib (Velcade ®), lenalidomide (Revlimid®), busulfan (Busilvex ®), Dexamethasone acetate, Melphalan
NCT04802356 phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

An Open Label, Multicenter, Phase II Study of Belantamab Mafodotin in Combination With VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients

TypeinterventionalSponsorPETHEMA FoundationRan2021 to 2026Enrolled50ConditionsMultiple MyelomaArmsBelantamab mafodotin, Bortezomib, Lenalidomide, Dexamethasone, Autologous stem cell transplant (ASCT)
NCT05558319 phase3recruitingnot on this mapstarted 2022, after this paper: background citation

GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D

TypeinterventionalSponsorPETHEMA FoundationRan2022 to 2029Enrolled480ConditionsNewly Diagnosed Multiple MyelomaArmsBortezomib, Isatuximab, Iberdomide, Lenalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Co-Occurrence of Cytogenetic Abnormalities and High-Risk Disease in Newly Diagnosed and Relapsed/Refractory Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Guideline
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

65 more citing papers are in PubMed but not listed here.

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

26 authors.

Laura RosiñolHospital Clínic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Albert OriolInstitut Català d'Oncologia I Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain.
Rafael RiosHospital Virgen de las Nieves, Granada, Spain.
Anna SuredaInstitut Català d'Oncologia-Hospitalet, Barcelona, Spain.
María Jesús BlanchardHospital Ramón y Cajal, Madrid, Spain.
Miguel Teodoro HernándezHospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
Rafael Martínez-MartínezHospital Universitario San Carlos, Madrid, Spain.
Jose M MoraledaHospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
Isidro JarqueHospital La Fe, Valencia, Spain.
Juan BargayHospital Son Llatzer, Palma de Mallorca, Spain.
Mercedes GironellaHospital Vall d'Hebron, Barcelona, Spain.
Felipe de ArribaServicio de Hematología y Oncología Médica, Hospital Universitario Morales Meseguer y Centro Regional de Hemodonación, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Luis PalomeraHospital Clínico Lozano Blesa, Zaragoza, Spain.
Yolanda González-MontesHospital Josep Trueta, Girona, Spain.
Josep M MartíHospital Mútua de Terrassa, Terrassa, Spain.
Isabel KrsnikHospital Puerta de Hierro, Madrid, Spain.
Jose M ArguiñanoComplejo Hospitalario de Navarra, Pamplona, Spain.
Maria Esther GonzálezHospital Cabueñes, Gijón, Spain.
Ana Pilar GonzálezHospital Central de Asturias, Oviedo, Spain.
Luis Felipe CasadoHospital Virgen de la Salud, Toledo, Spain.
Lucia López-AngladaHospital Universitario 12 de Octubre, Madrid, Spain.
Bruno PaivaClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain; and.
Maria-Victoria MateosHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain.
Jesus F San MiguelClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain; and.
Juan-José LahuertaHospital Universitario 12 de Octubre, Madrid, Spain.
Joan BladéHospital Clínic, Institut d'investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Achieving and maintaining a high-quality response is the treatment goal for patients with newly diagnosed multiple myeloma (NDMM). The phase 3 PETHEMA/GEM2012 study, in 458 patients aged ≤65 years with NDMM, is evaluating bortezomib (subcutaneous) + lenalidomide + dexamethasone (VRD) for 6 cycles followed by autologous stem cell transplant (ASCT) conditioned with IV busulfan + melphalan vs melphalan and posttransplant consolidation with 2 cycles of VRD. We present grouped response analysis of induction, transplant, and consolidation. Responses deepened over time; in patients who initiated cycle 6 of induction (n = 426), the rates of a very good partial response or better were 55.6% by cycle 3, 63.8% by cycle 4, 68.3% by cycle 5, and 70.4% after induction. The complete response rate of 33.4% after induction in the intent-to-treat (ITT) population, which was similar in the 92 patients with high-risk cytogenetics (34.8%), also deepened with further treatment (44.1% after ASCT and 50.2% after consolidation). Rates of undetectable minimal residual disease (median 3 × 10-6 sensitivity) in the ITT population also increased from induction (28.8%) to transplant (42.1%) and consolidation (45.2%). The most common grade ≥3 treatment-emergent adverse events during induction were neutropenia (12.9%) and infection (9.2%). Grade ≥2 peripheral neuropathy (grouped term) during induction was 17.0%, with a low frequency of grade 3 (3.7%) and grade 4 (0.2%) events. VRD is an effective and well-tolerated regimen for induction in NDMM with deepening response throughout induction and over the course of treatment. This trial was registered at www.clinicaltrials.gov as #NCT01916252 and EudraCT as #2012-005683-10.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBortezomibChemotherapy, AdjuvantDexamethasoneFemaleHematopoietic Stem Cell TransplantationHumansInduction ChemotherapyLenalidomideMaleMiddle AgedMultiple MyelomaNeoadjuvant TherapyTransplantation, AutologousBortezomibDexamethasoneLenalidomide

Identifiers

PMID31484647
PMCPMC6888142

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.