Evidence map›Paper›PMID 25027515›Full record

Trial reportLeukemia2015

Long-term results of the GIMEMA VEL-03-096 trial in MM patients receiving VTD consolidation after ASCT: MRD kinetics' impact on survival.

S Ferrero, M Ladetto, D Drandi, F Cavallo, E Genuardi, M Urbano, S Caltagirone, M Grasso, F Rossini, T Guglielmelli and 15 more

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05558319 (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), which is not on this map. Cited by 47 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 3 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.

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

47 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Minimal residual disease in multiple myeloma: why, when, where.Hematology. American Society of Hematology. Education Program · 2021
    Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. What to do with minimal residual disease testing in myeloma.Hematology. American Society of Hematology. Education Program · 2019
    Article
  20. 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

25 authors.

S FerreroDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
M LadettoDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
D DrandiDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
F Cavallo1] Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy [2] GIMEMA Italian Myeloma Network, Italy.
E GenuardiDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
M UrbanoDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
S CaltagironeDivision of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy.
M GrassoGIMEMA Italian Myeloma Network, Italy.
F RossiniGIMEMA Italian Myeloma Network, Italy.
T GuglielmelliGIMEMA Italian Myeloma Network, Italy.
C CangialosiGIMEMA Italian Myeloma Network, Italy.
A M LiberatiGIMEMA Italian Myeloma Network, Italy.
V CalleaGIMEMA Italian Myeloma Network, Italy.
T CarovitaGIMEMA Italian Myeloma Network, Italy.
C CrippaGIMEMA Italian Myeloma Network, Italy.
L De RosaGIMEMA Italian Myeloma Network, Italy.
F PisaniGIMEMA Italian Myeloma Network, Italy.
A P FalconeGIMEMA Italian Myeloma Network, Italy.
P PregnoGIMEMA Italian Myeloma Network, Italy.
S Oliva1] Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy [2] GIMEMA Italian Myeloma Network, Italy.
C TerragnaGIMEMA Italian Myeloma Network, Italy.
P MustoGIMEMA Italian Myeloma Network, Italy.
R PasseraDivision of Nuclear Medicine, Città della Salute e della Scienza, University of Torino, Torino, Italy.
M Boccadoro1] Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy [2] GIMEMA Italian Myeloma Network, Italy.
A Palumbo1] Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino, Torino, Italy [2] GIMEMA Italian Myeloma Network, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polymerase chain reaction (PCR)-based minimal residual disease (MRD) analysis is a useful prognostic tool in multiple myeloma (MM), although its long-term impact still needs to be addressed. This report presents the updated results of the GIMEMA-VEL-03-096 trial. Thirty-nine MM patients receiving bortezomib-thalidomide-dexamethasone after autologous transplantation were monitored for MRD by both nested and real-time quantitative-PCR until relapse. Our data confirm the strong impact of MRD on survival: overall survival was 72% at 8 years median follow-up for patients in major MRD response versus 48% for those experiencing MRD persistence (P=0.041). In addition, MRD kinetics resulted predictive for relapse: indeed median remission duration was not reached for patients in major MRD response, 38 months for those experiencing MRD reappearance and 9 months for patients with MRD persistence (P<0.001). Moreover: (1) 26 patients achieving major MRD response (67%) benefit of excellent disease control (median TNT: 42 months); (2) MRD reappearance heralds relapse, with a TNT comparable to that of MRD persistence (9 versus 10 months, P=0.706); (3) the median lag between MRD reappearance and need for salvage treatment is 9 months. These results suggest the usefulness of a long-term MRD monitoring in MM patients and the need for maintenance or pre-emptive treatments ensuring durable responses.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHematopoietic Stem Cell TransplantationAdultAgedBoronic AcidsBortezomibDexamethasoneFemaleFollow-Up StudiesGene ExpressionHumansImmunoglobulin Heavy ChainsMaleMiddle AgedMultiple MyelomaNeoplasm, ResidualBoronic AcidsBortezomibDexamethasoneImmunoglobulin Heavy ChainsPyrazinesThalidomide

Identifiers

PMID25027515

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.