Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
26. juni 2015 opdateret af: Janssen Korea, Ltd., Korea
A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation
The purpose of this study is to assess the 2-year progression-free survival rate.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This was a prospective, open-label, multicenter, observational study.
Participants who received bortezomib, Melphalan, Prednisone(VMP) therapy for Multiple myeloma (MM) that was not eligible for autologous stem cell transplantation will be enrolled in the study.
The study will consist of Screening phase; VMP therapy phase (9cycles); Follow-up phase (2 years from the day when the first cycle was started).
Participants visited each institution for evaluation for 2 years from the date of baseline evaluation and first VMP administration (duration of treatment, 9 cycles; follow-up visits, every 3 months after the end of the treatment).
Participants receiving VMP therapy will be primarily evaluated for 2-year progression-free survival rate.
Participants safety will be monitored throughout the study.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
171
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Anyang, Korea, Republikken
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Busan, Korea, Republikken
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Cheonan, Korea, Republikken
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Cheonan City, Korea, Republikken
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Chungcheongbuk-Do, Korea, Republikken
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Dae-Gu, Korea, Republikken
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Daegu, Korea, Republikken
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Daejeon, Korea, Republikken
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Daejon, Korea, Republikken
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Gyeonggi-Do, Korea, Republikken
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Hwasun Gun, Korea, Republikken
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Iksan, Korea, Republikken
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Incheon, Korea, Republikken
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Jeonju-Si, Korea, Republikken
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Jinju-Si, Korea, Republikken
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Pucheon, Korea, Republikken
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Pusan, Korea, Republikken
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Seongnam, Korea, Republikken
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Seoul, Korea, Republikken
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Suwon, Korea, Republikken
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Ulsan, Korea, Republikken
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
Beskrivelse
Inclusion Criteria:
- Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation
- Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol
- Participants with presence of an illness that is detectable by definitions as defined in protocol
- Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial
Exclusion Criteria:
- Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone < 160mg in total)
- Participants with severe peripheral neuropathy (Grade >= 2 by NCI CTC version 4.0)
- Pregnant or breastfeeding mothers
- Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial
- Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Bortezomib, Melphalan, Prednisone (VMP) Group
Participants will not receive any intervention in this study.
Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
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Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
Participants receiving Melphalan 9 mg/m^2 will be observed in this study.
Participants receiving Prednisone 60 mg/m^2 will be observed in this study.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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2-year Progression-free Survival Rate
Tidsramme: Up to 2 years
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Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.
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Up to 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Response
Tidsramme: up to 2 years
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Time from the first day of Bortezomib administration to the day of confirmed first response in participants with confirmed response, or to the day of loss to follow-up, disease progression, death or completion of study therapy in participants without response.
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up to 2 years
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Overall Response Rate
Tidsramme: up to 2 years
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Percentage of participants who achieved CR, VGPR or PR in 2 years.
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up to 2 years
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Complete Response Rate
Tidsramme: up to 2 years
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Percentage of participants who achieved CR as best response.
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up to 2 years
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Time to Next therapy
Tidsramme: up to 2 years
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The next therapy after the end of the study therapy was investigated, and the time from the day when the first therapy was started to the day when the next therapy was started was calculated.
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up to 2 years
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Time to Disease Progression
Tidsramme: up to 2 years
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Time from the first day of Bortezomib administration to the day of disease progression or relapse from complete response, whichever comes first.
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up to 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2011
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
15. juni 2015
Først indsendt, der opfyldte QC-kriterier
15. juni 2015
Først opslået (Skøn)
17. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Myelomatose
- Neoplasmer, Plasmacelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Prednison
- Melphalan
- Bortezomib
Andre undersøgelses-id-numre
- CR018445
- 26866138MMY4056 (Anden identifikator: Janssen Korea, Ltd., Korea)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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