Evidence map›Paper›PMID 38988266›Full record

Trial reportHaematologica2024

Single-point and kinetics of peripheral residual disease by mass spectrometry to predict outcome in patients with high-risk smoldering multiple myeloma included in the GEM-CESAR trial.

Noemí Puig, Cristina Agulló, Teresa Contreras, José-Juan Pérez, Irene Aires, María-José Calasanz, Ramón García-Sanz, Sergio Castro, Joaquín Martínez-López, Paula Rodríguez-Otero and 27 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2024. 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. Article
  5. 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

37 authors.

Noemí PuigHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Cristina AgullóBiochemistry Department, University Hospital of Salamanca, Salamanca.
Teresa ContrerasBiochemistry Department, University Hospital of Salamanca, Salamanca.
José-Juan PérezHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Irene AiresHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
María-José CalasanzHematology Department, Cancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), IDISNA, CIBERONC, Pamplona.
Ramón García-SanzHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Sergio CastroHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Joaquín Martínez-LópezHematology Department, Hospital 12 de Octubre, Medicine Department, Medicine School of Complutense University, I+12. CNIO, Madrid.
Paula Rodríguez-OteroHematology Department, Cancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), IDISNA, CIBERONC, Pamplona.
Verónica González-CalleHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Marta S GonzálezHematology Department, Hospital Clínico Universitario Santiago de Compostela, Santiago de Compostela.
Albert OriolClinical Hematology, Institut Català d'Oncologia and Josep Carreras Research Institute, Hospital Germans Trias I Pujol, Badalona.
Norma C GutiérrezHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca.
Rafael Ríos-TamayoUnidad de Gammapatías Monoclonales. Hospital Universitario Puerta de Hierro, Majadahonda.
Laura RosiñolHematology Department, Hospital Clinic, IDIBARS, Barcelona.
Miguel-Ángel ÁlvarezHematology Department, Hospital Universitario Reina Sofía, Córdoba.
Joan BargayHematology Department, Hospital Universitario Son Llatzer, IdISBa (Institut d'Investigació Sanitaria Illes Balears), Palma.
Ana-Pilar González-RodríguezHematology Department, Hospital Universitario Central de Asturias, Oviedo.
Adrián AlegreUniversity Hospital La Princesa and University Hospital QuironSalud, Autónoma University, Madrid.
Fernando EscalanteServicio de Hematología, Unidad i+i, Complejo Asistencial Universitario de León, León.
María-Belén IñigoHematology Department, Hospital Clínico San Carlos, Madrid.
Javier De la RubiaHematology Department, Hospital Universitario y Politécnico La Fe, Universidad Católica de Valencia, CIBERONC, Valencia.
Ana-Isabel TeruelHematology Department, Hospital Clínico Universitario de Valencia, Valencia.
Felipe De ArribaHematology Department, Hospital Universitario Morales Meseguer, IMIBPascual.
Luis PalomeraHematology Department, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria de Aragón, Zaragoza.
Miguel T HernándezHematology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife.
Javier López-JiménezHematology Department, Hospital Ramón y Cajal, Madrid.
Marta ReinosoHematology Department, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBIS) / CSIC, Universidad de Sevilla, Sevilla.
Aránzazu García-MateoHematology Department, Complejo Asistencial de Segovia, Segovia.
Enrique M OcioHematology Department, Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander.
Joan BladéHematology Department, Hospital Clinic, IDIBARS, Barcelona.
Juan-José LahuertaInstituto de Investigación, Hospital Universitario 12 de Octubre, Madrid.
María-Teresa CedenaHematology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación i+12, Madrid.
Bruno PaivaHematology Department, Cancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), IDISNA, CIBERONC, Pamplona.
Jesús F San MiguelHematology Department, Cancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), IDISNA, CIBERONC, Pamplona.
María-Victoria MateosHematology Department, Hospital Universitario de Salamanca-IBSAL, CIBERONC and Centro de Investigación del Cáncer, IBMCC (USAL-CSIC), Salamanca. mvmateos@usal.es.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The value of quantitative immunoprecipitation mass spectrometry (QIP-MS) to identify the M-protein is being investigated in patients with monoclonal gammopathies but no data are yet available in high-risk smoldering myeloma (HRsMM). We have, therefore, investigated QIP-MS to monitor peripheral residual disease (PRD) in 62 HRsMM patients enrolled in the GEM-CESAR trial. After 24 cycles of maintenance, detecting the M-protein by MS or clonal plasma cells by next-generation flow cytometry (NGF) identified cases with a significantly shorter median progression-free survival (mPFS) (MS: not reached vs. 1.4 years, P=0.001; NGF: not reached vs. 2 years, P=0.0002) but reaching complete response (CR) + stringent CR (sCR) did not discriminate between patients with different outcome. With NGF as a reference, the combined results of NGF and MS showed a high negative predictive value (NPV) of MS: 81% overall and 73% at treatment completion. When sequential results were considered, sustained negativity by MS or NGF was associated with a very favorable outcome with an mPFS not yet reached versus 1.66 years and 2.18 years in cases never attaining PRD or minimal residual disease (MRD) negativity, respectively. We can, thus, conclude that: 1) the standard response categories of the International Myeloma Working Group do not seem to be useful for monitoring treatment in HRsMM patients; 2) MS could be used as a valuable, non-invasive, clinical tool with the capacity of guiding timely bone marrow evaluations (based on its high NPV with NGF as a reference); and 3) similarly to NGF, sequential results of MS are able to identify a subgroup of HRsMM patients with long-term disease control. This study was registered at www.clinicaltrials.gov (clinicaltrials.gov identifier: 02415413).

Indexed as

Mass SpectrometryNeoplasm, ResidualSmoldering Multiple MyelomaAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedMultiple MyelomaMyeloma ProteinsPrognosisTreatment OutcomeMyeloma Proteins

Identifiers

PMID38988266
PMCPMC11609803

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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.