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An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

15 februari 2022 uppdaterad av: Takeda

A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits.

The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

  • ND MM within 3 months from initiation of treatment
  • R/R MM who have received 1 to 3 prior lines of therapy

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Studietyp

Observationell

Inskrivning (Faktisk)

4310

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Belgien
      • Charleroi, Belgien, 6000
        • Grand Hôpital de Charleroi asbl
      • Gent, Belgien, 9000
        • UZ Gent
      • Haine-Saint-Paul, Belgien, 7100
        • Hopital de Jolimont
      • Leuven, Belgien, 3000
        • UZ Leuven
      • Liege, Belgien, 4000
        • CHU de Liège
      • Yvoir, Belgien, 5530
        • CHU UCL Namur asbl - Site Godinne
  • Brasilien
      • Campinas, Brasilien, 13083-970
        • Unicamp Universidade Estadual de Campinas
      • Florianopolis, Brasilien, 88034
        • Centro de Pesquisas Oncologicas
      • Goiania, Brasilien, 74680-160
        • Hospital das Clínicas da Universidade Federal de Goiás
      • Rio de Janeiro, Brasilien, 21941-913
        • Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho
      • Salvador, Brasilien, 40110-090
        • CEHON - Centro de Hematologia e Oncologia da Bahia Ltda
      • Sao Paulo, Brasilien, 05651-901
        • Hospital israelita Albert Einstein
      • Sao Paulo, Brasilien, 5403000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • Sao Paulo, Brasilien, 04537-081
        • Clinica Sao Germano
  • Colombia
      • Bogota, Colombia
        • Fundación Santa Fe de Bogota
      • Floridablanca, Colombia
        • Fundación Oftalmológica de Santander FOSCAL
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
      • Monteria, Colombia
        • Oncomedica SA
  • Frankrike
      • Bayonne, Frankrike, 64109
        • Centre Hospitalier de la Cote Basque
      • Le Mans, Frankrike, 72000
        • Centre Hospitalier Le Mans
      • Perigueux, Frankrike, 24019
        • Centre Hospitalier de Périgueux
      • Poitiers, Frankrike, 86021
        • CHRU de Poitiers La Miletrie
      • Roche-sur-Yon, Frankrike, 85000
        • Centre Hospitalier Departemental de Vendee
      • Vandoeuvre-les-nancy, Frankrike, 54211
        • CHU de Nancy-Hopital Brabois Adulte
  • Förenta staterna
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Förenta staterna, 72205
        • CARTI Cancer Center
    • California
      • La Jolla, California, Förenta staterna, 92093
        • University of California San Diego
      • Santa Rosa, California, Förenta staterna, 95403
        • St Joseph Heritage Healthcare
    • Colorado
      • Denver, Colorado, Förenta staterna, 80218
        • Rocky Mountain Cancer Centers (Williams) - USOR
      • Fort Collins, Colorado, Förenta staterna, 80528
        • Poudre Valley Health System
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20037
        • George Washington University
    • Florida
      • Daytona Beach, Florida, Förenta staterna, 32117
        • SCRI Florida Cancer Specialists East
      • Fort Myers, Florida, Förenta staterna, 33916
        • SCRI Florida Cancer Specialists South
      • Saint Petersburg, Florida, Förenta staterna, 33705
        • Scri Florida Cancer Specialists North
    • Illinois
      • Niles, Illinois, Förenta staterna, 60714
        • Illinois Cancer Specialists (Niles) - USOR
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Indiana University
    • Louisiana
      • Metairie, Louisiana, Förenta staterna, 70006
        • East Jefferson General Hospital
    • Maine
      • Lewiston, Maine, Förenta staterna, 04240
        • Central Maine Medical Center
    • Maryland
      • Columbia, Maryland, Förenta staterna, 21044
        • Maryland Oncology Hematology (Columbia) - USOR
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48201
        • Barbara Ann Karmanos Cancer Center
    • Minnesota
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • Park Nicollet Institute
    • Missouri
      • Bolivar, Missouri, Förenta staterna, 65613
        • Central Care Cancer Center
      • Kansas City, Missouri, Förenta staterna, 64128
        • Kansas City VA Medical Center
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University in St. Louis
    • New Jersey
      • Flemington, New Jersey, Förenta staterna, 08822
        • Hunterdon Hematology Oncology
    • New Mexico
      • Farmington, New Mexico, Förenta staterna, 87401
        • San Juan Oncology Associates
    • New York
      • East Hills, New York, Förenta staterna, 11576
        • Saint Francis Hospital
      • New York, New York, Förenta staterna, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28402
        • Levine Cancer Center
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45220
        • University of Cincinnati
    • Oregon
      • Medford, Oregon, Förenta staterna, 97504
        • Hematology Oncology Associates - USOR
      • Portland, Oregon, Förenta staterna, 97227
        • Northwest Cancer Specialists (Broadway) - USOR
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Förenta staterna, 15240
        • Veterans Affairs Pittsburgh Healthcare System
    • South Carolina
      • Greenville, South Carolina, Förenta staterna, 29615
        • Greenville Health System Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37203
        • SCRI Tennessee Oncology Nashville
    • Texas
      • Amarillo, Texas, Förenta staterna, 79106
        • Texas Oncology (LOOP) - USOR
      • Dallas, Texas, Förenta staterna, 92056
        • Texas Oncology (LOOP) - USOR
      • El Paso, Texas, Förenta staterna, 79902
        • Texas Oncology (LOOP) - USOR
      • Houston, Texas, Förenta staterna, 77030
        • University of Texas MD Anderson Cancer Center
      • Round Rock, Texas, Förenta staterna, 78681
        • Texas Oncology (LOOP) - USOR
      • San Antonio, Texas, Förenta staterna, 78217
        • Texas Oncology (LOOP) - USOR
    • Washington
      • Yakima, Washington, Förenta staterna, 98902
        • Yakima Valley Memorial Hospital North Star Lodge - USOR
    • West Virginia
      • Martinsburg, West Virginia, Förenta staterna, 25401
        • Berkeley Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, Förenta staterna, 54307
        • St Vincent Hospital
      • Madison, Wisconsin, Förenta staterna, 53792
        • University of Wisconsin Carbone Cancer Center
      • Milwaukee, Wisconsin, Förenta staterna, 53215
        • Aurora Health Care, Aurora Cancer Care
  • Grekland
      • Alexandroupoli, Grekland, 68100
        • University Hospital of Alexandroupolis
      • Athens, Grekland, 10676
        • Evangelismos General Hospital of Athens
      • Athens, Grekland, 11525
        • Alexandra Hospital
      • Ioannina, Grekland, 45500
        • University General Hospital of Ioannina
      • Larisa, Grekland, 41110
        • University General Hospital of Larissa
      • Patras, Grekland, 26500
        • University General Hospital of Patras
  • Israel
      • Afula, Israel, 18371
        • HaEmek Medical Center
      • Haifa, Israel, 34362
        • Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Kefar-Sava, Israel, 44281
        • Meir Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 69710
        • Assuta Medical Centers
  • Italien
      • Ancona, Italien, 60020
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
      • Bologna, Italien, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Catania, Italien
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Firenze, Italien, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Napoli, Italien
        • Azienda Ospedaliera Universitaria Federico II
      • Roma, Italien, 00161
        • Azienda Policlinico Umberto I
      • Torino, Italien
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Udine, Italien, 33100
        • Azienda Sanitaria Universitaria Integrata di Udine
  • Kalkon
      • Adana, Kalkon
        • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
      • Ankara, Kalkon
        • Ankara University Medical Faculty Cebeci Hospital
      • Antalya, Kalkon
        • Akdeniz University Medical Faculty
      • Gebze, Kalkon
        • Johns Hopkins Medicine - Anadolu Saglik Merkezi
      • Istanbul, Kalkon
        • Ege Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Kalkon
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Izmir, Kalkon
        • Dokuz Eylul University Medical Faculty
      • Kayseri, Kalkon
        • Erciyes Universitesi Tip Fakultesi Hastanesi
      • Samsun, Kalkon
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Trabzon, Kalkon
        • Karadeniz Technical University Faculty of Medicine
  • Kina
      • Beijing, Kina, 100730
        • Peking Union Medical College Hospital
      • Beijing, Kina
        • Peking University Peoples Hospital
      • Hangzhou, Kina, 310003
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Suzhou, Kina, 215006
        • First Affiliated Hospital of Soochow University
  • Mexiko
      • Guadalajara, Mexiko, 44670
        • Nucleo Oncologico de Occidente S.C.
      • Huixquilucan, Mexiko
        • Hematologica Alta Especialidad S.C.
      • Mexico City, Mexiko, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Monterrey, Mexiko, 64460
        • Hospital Universitario Dr. Jose Eleuterio González
  • Spanien
      • Barcelona, Spanien, 8036
        • Hospital Clinic de Barcelona
      • Granada, Spanien, 18014
        • Hospital Universitario Virgen de las Nieves
      • Leon, Spanien, 24080
        • Complejo Asistencial Universitario de León
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spanien, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spanien
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Storbritannien
      • Bath, Storbritannien
        • Royal United Hospital
      • Birmingham, Storbritannien, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, Storbritannien, B15 2TH
        • University Hospital Birmingham
      • Bournemouth, Storbritannien, BH7 7DW
        • Royal Bournemouth Hospital
      • Dundee, Storbritannien, DD1 9SY
        • Ninewells Hospital - PPDS
      • Leicester, Storbritannien, LE1 5WW
        • Leicester Royal Infirmary
      • Nottingham, Storbritannien, NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Sutton, Storbritannien, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
      • Wakefield, Storbritannien, WF1 4DG
        • Pinderfields General Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, Storbritannien, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
    • Chiayi County
      • Puzi, Chiayi County, Taiwan, 613
        • Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
  • Tyskland
      • Chemnitz, Tyskland
        • Klinikum Chemnitz gGMbH
      • Dortmund, Tyskland
        • Gefos - Gesellschaft fur onkologische Studien mbH
      • Heidelberg, Tyskland
        • Universitätsklinikum Heidelberg
      • Herrsching am Ammersee, Tyskland
        • Internistisch Hamatologische und Internistische Praxis
      • Koblenz, Tyskland
        • Institut fur Versorgungsforschung in der Onkologie GbR
      • Mainz, Tyskland
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Tyskland
        • Mannheimer Onkologie Praxis
      • Marburg, Tyskland
        • OnkoNet Marburg GmbH
      • Siegburg, Tyskland
        • Onkologische Gemeinschaftspraxis Siegburg
      • Tubingen, Tyskland
        • Universitätsklinikum Tübingen

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Participants with Multiple Myeloma

Beskrivning

Inclusion Criteria:

Is 18 years of age or older.

Is experiencing the following:

  1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or
  2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.

Exclusion Criteria:

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Relapsed/refractory (R/R) MM
Patients who have received 1 to 3 prior lines of therapy
Övrig: Inget ingripande
Newly diagnosed (ND) MM
Patients within 3 months from initiation of treatment
Övrig: Inget ingripande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants with Co-morbidities
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Diagnosed with ND MM and R/R MM
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Presenting Symptoms of ND MM and R/R MM
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Sites of Disease
Tidsram: Baseline up to 8 years
Baseline up to 8 years
ECOG (Eastern Cooperative Oncology Group) Performance Status
Tidsram: Baseline up to 8 years
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Baseline up to 8 years
Frailty Index
Tidsram: Baseline up to 8 years
Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.
Baseline up to 8 years
Number of Participants Evaluated for Laboratory Test
Tidsram: Baseline up to 8 years
Laboratory tests include minimal residual disease (MRD), gene expression profiling (GEP), fluorescence in situ hybridization (FISH), and cytogenetic results, international staging system (ISS)/R-ISS stage, imaging results.
Baseline up to 8 years
Duration for Treatment With Stem Cell Transplant
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Reporting Overall Survival
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Progression Status on Each Regimen
Tidsram: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Response to Each Regimen
Tidsram: Baseline up to 8 years
Disease progression status was assessed by IMWG Response criteria
Baseline up to 8 years
Time to Next therapy
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Participants With Stem Cell Transplant
Tidsram: Baseline up to 8 years
Baseline up to 8 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Treatment Combinations
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Treatment Sequencing
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Treatment Rechallenge
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Clinical Outcomes for Different Strategies
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Reasons for Treatment Modifications
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Health Related Quality of Life (HRQoL) Among MM Participants
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Healthcare Resource Utilization (HRU) Among MM Participants
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Associations Between Presentation and Disease Characteristics
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Associations Between Choice Of Therapy and Clinical Outcomes
Tidsram: Baseline up to 8 years
Baseline up to 8 years
Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events
Tidsram: Baseline up to 8 years
Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
Baseline up to 8 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Takeda

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2016

Primärt slutförande (Faktisk)

30 september 2021

Avslutad studie (Faktisk)

30 september 2021

Studieregistreringsdatum

Först inskickad

28 april 2016

Först inskickad som uppfyllde QC-kriterierna

2 maj 2016

Första postat (Uppskatta)

4 maj 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NSMM-5001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Kriterier för IPD Sharing Access

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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