Evidence map›Paper›PMID 34021118›Full record

Trial reportBlood cancer journal2021

Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial.

Noemi Puig, Miguel T Hernández, Laura Rosiñol, Esther González, Felipe de Arriba, Albert Oriol, Verónica González-Calle, Fernando Escalante, Javier de la Rubia, Mercedes Gironella and 28 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood cancer journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02575144 (GEM-CLARIDEX), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 9% of its field
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.

NCT02575144 phase3unknown statusnot on this map

GEM-CLARIDEX: Lenalidomide and Dexamethasone (Ld) Versus Clarithromycin / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as Initial Therapy in Multiple Myeloma

TypeinterventionalSponsorPETHEMA FoundationRan2015 to 2024Enrolled286ConditionsMultiple MyelomaArmsClarithromycin, Lenalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Short-Chain Fatty Acid Production by Gut Microbiota Predicts Treatment Response in Multiple Myeloma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  10. Article
  11. More Than 2% of Circulating Tumor Plasma Cells Defines Plasma Cell Leukemia-Like Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  12. Article
  13. 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

38 authors at 20 institutions in 2 countries.

Noemi PuigHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain.
Miguel T HernándezHospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.ORCID 0000-0002-6576-7881
Laura RosiñolHematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain.
Esther GonzálezHospital Universitario de Cabueñes, Gijón, Spain.
Felipe de ArribaHospital Morales Meseguer, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.
Albert OriolInstitut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.ORCID 0000-0001-6804-2221
Verónica González-CalleHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain.
Fernando EscalanteHospital Universitario de León, León, Spain.
Javier de la RubiaHematology Department, Catholic University of Valencia and Hospital Doctor Peset, Valencia, Spain.
Mercedes GironellaHospital Univeristari Vall d´Hebron, Barcelona, Spain.
Rafael RíosHospital Universitario Virgen de las Nieves, Instituto de Investigación Biosanitaria IBS GRANADA, Granada, Spain.
Ricarda García-SánchezHospital Universitario Virgen de la Victoria, Málaga, Spain.
José M ArguiñanoComplejo Hospitalario de Navarra, Pamplona, Spain.
Adrián AlegreHospital Universitario de La Princesa, Sevilla, Spain.
Jesús MartínHospital Universitario Virgen del Rocío, Sevilla, Spain.ORCID 0000-0003-4250-4824
Norma C GutiérrezHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain.
María J CalasanzClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain.ORCID 0000-0002-0374-3008
María L MartínHospital Universitario 12 de Octubre, CIBERONC, Instituto de Investigación, IMAS12, Madrid, Spain.
María Del Carmen CoutoHospital Universitario Virgen de Valme, Sevilla, Spain.
María CasanovaHematology Department, Hospital Costa del Sol de Marbella, Marbella, Spain.
Mario ArnaoHematology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
Ernesto Pérez-PersonaBioaraba Health Research Institute, Oncohematology Research Group; Osakidetza, Álava University Hospital, Hematology Department, Vitoria-Gasteiz, Spain.
Sebastián GarzónHospital del SAS de Jerez, Jerez de la Frontera, Spain.
Marta S GonzálezHospital Universitario de Santiago, Santiago de Compostela, Spain.
Guillermo Martín-SánchezHematology Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Enrique M OcioHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain.
Morton ColemanDivision of Hematology and Oncology, Weill Cornell Medicine, New York, NY, USA.
Cristina EncinasHospital Universitario Gregorio Marañón, Madrid, Spain.
Ana M ValeCHUAC, A Coruña, Spain.
Ana I TeruelHospital Clínico Universitario de Valencia, Valencia, Spain.
María Cortés-RodríguezHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain.
Bruno PaivaClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain.ORCID 0000-0003-1977-3815
M Teresa CedenaHospital Universitario 12 de Octubre, CIBERONC, Instituto de Investigación, IMAS12, Madrid, Spain.
Jesús F San-MiguelClínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain.ORCID 0000-0002-9183-4857
Juan J LahuertaInstituto de Investigación del Hospital Universitario, 12 de Octubre, Madrid, Spain.ORCID 0000-0002-3393-9570
Joan BladéHematology Department, Hospital Clinic, IDIBAPS, Barcelona, Spain.
Ruben NiesvizkyDivision of Hematology and Oncology, Weill Cornell Medicine, New York, NY, USA.
María-Victoria MateosHematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC), CIBERONC, Salamanca, Spain. mvmateos@usal.es.ORCID 0000-0003-2390-1218
Instituto de Investigación Biomédica de Salamanca · ESClinica Universidad de Navarra · ESHospital Universitario 12 De Octubre · ESCornell University · USHospital Clínic de Barcelona · ESComplejo Hospitalario de Navarra · ESComplejo Hospitalario Universitario de Santiago · ESComplexo Hospitalario Universitario A Coruña · ESHospital Clínico Universitario de Valencia · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital Costa del Sol · ESHospital de León · ESHospital General Universitario Gregorio Marañón · ESHospital General Universitario Morales Meseguer · ESHospital Jerez Puerta del Sur · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Araba · ESHospital Universitario De Cabueñes · ESHospital Universitario de Canarias · ESHospital Universitario de La Princesa · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0-54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3-4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the ≥CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsClarithromycinDexamethasoneFemaleHematopoietic Stem Cell TransplantationHumansLenalidomideMaleMultiple MyelomaTransplantation, AutologousTreatment OutcomeClarithromycinDexamethasoneLenalidomide

Identifiers

PMID34021118
PMCPMC8139975
OpenAlexW3162625477

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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.