Evidence map›Paper›PMID 27081177›Full record

Trial reportHaematologica2016

Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma.

Katja C Weisel, Meletios A Dimopoulos, Philippe Moreau, Martha Q Lacy, Kevin W Song, Michel Delforge, Lionel Karlin, Hartmut Goldschmidt, Anne Banos, Albert Oriol and 13 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

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

11 citing papers in PubMed, 20 citations in OpenAlex.

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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

23 authors at 17 institutions in 9 countries.

Katja C WeiselHematology and Oncology, Department of Medicine, University Hospital Tübingen, Germany katja.weisel@med.uni-tuebingen.de.
Meletios A DimopoulosNational and Kapodistrian University of Athens, Greece.
Philippe MoreauHematology, University Hospital Hôtel-Dieu, Nantes, France.
Martha Q LacyDivision of Hematology, Mayo Clinic, Rochester, MN, USA.
Kevin W SongVancouver General Hospital, BC, Canada.
Michel DelforgeDepartment of Hematology, University Hospitals Leuven, Belgium.
Lionel KarlinCentre Hospitalier Lyon Sud/Hospices Civils de Lyon, Pierre-Bénite, France.
Hartmut GoldschmidtUniversitäts Klinikum Heidelberg, Germany.
Anne BanosHematology, Centre Hospitalier de la Côte Basque, Bayonne, France.
Albert OriolInstitut Catala d'Oncologia, Hospital Germans Trias I Pujol, Barcelona, Spain.
Adrian AlegreHospital Universitario La Princesa, Madrid, Spain.
Christine ChenPrincess Margaret Hospital, Toronto, ON, Canada.
Michele CavoBologna University School of Medicine, Institute of Hematology and Medical Oncology, Bologna, Italy.
Laurent GarderetHôpital Saint-Antoine, Paris, France.
Valentina IvanovaGUZ Moscow City Clinical Hospital S. P. Botkin, Moscow, Russia.
Joaquin Martinez-LopezHospital Universitario 12 de Octubre, Madrid, Spain.
Stefan KnopHematology and Oncology, Würzburg University Medical Center, Würzburg, Germany.
Xin YuCelgene Corporation, Summit, NJ, USA.
Kevin HongCelgene Corporation, Summit, NJ, USA.
Lars SternasCelgene Corporation, Summit, NJ, USA.
Christian JacquesCelgene Corporation, Summit, NJ, USA.
Mohamed H ZakiCelgene Corporation, Summit, NJ, USA.
Jesus San MiguelClínica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.
Botkin Hospital · RUCentre Hospitalier de la Côte Basque · FRClinica Universidad de Navarra · ESHeidelberg University · DEHôpital Saint-Antoine · FRHospices Civils de Lyon · FRHospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESInstitut Català d'Oncologia · ESKU Leuven · BEMayo Clinic in Arizona · USNational and Kapodistrian University of Athens · GRPrincess Margaret Cancer Centre · CAUniversitätsklinikum Würzburg · DEUniversity Children's Hospital Tübingen · DEUniversity of Bologna · ITVancouver General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 - < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 - < 60 mL/min (P<0.001) and 4.0 versus 2.0 months in the group with baseline creatinine clearance ≥ 60 mL/min (P<0.001). Median overall survival for pomalidomide + low-dose dexamethasone versus high-dose dexamethasone was 10.4 versus 4.9 months (P=0.030) and 15.5 versus 9.2 months (P=0.133), respectively. Improved renal function, defined as an increase in creatinine clearance from < 60 to ≥ 60 mL/min, was similar in pomalidomide + low-dose dexamethasone and high-dose dexamethasone patients (42% and 47%, respectively). Improvement in progression-free and overall survival in these patients was comparable with that in patients without renal impairment. There was no increase in discontinuations of therapy, dose modifications, and adverse events in patients with moderate renal impairment. Pomalidomide at a starting dose of 4 mg + low-dose dexamethasone is well tolerated in patients with refractory or relapsed and refractory multiple myeloma, and of comparable efficacy if moderate renal impairment is present. This trial was registered with clinicaltrials.gov identifier 01311687 and EudraCT identifier 2010-019820-30.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFollow-Up StudiesHumansKidney Function TestsMaleMiddle AgedMultiple MyelomaRenal InsufficiencyRetreatmentSurvival AnalysisThalidomideDexamethasonepomalidomideThalidomide

Identifiers

PMID27081177
PMCPMC5004467
OpenAlexW2335826388

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.