- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01241708
Tandem autostamcelletransplantation med melphalan efterfulgt af melphalan og bortezomib hos patienter med myelomatose ((Mel/MelVel))
Tandem autolog hæmatopoietisk stamcelletransplantation med melphalan efterfulgt af melphalan og bortezomib hos patienter med myelomatose
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Mange patienter med myelomatose får 2 stamcelletransplantationer inden for få måneder efter hinanden som en del af deres behandling. Normalt bruges stoffet Melphalan til begge transplantationer.
Bortezomib er et lægemiddel, der bruges til behandling af myelomatose og er blevet brugt i kombination med melphalan til stamcelletransplantation til patienter med myelomatose.
Formålet med dette forsøg er at undersøge virkningerne af at udføre 2 transplantationer, først med melphalan og for det andet melphalan og bortezomib. Forsøget har til formål at finde ud af, om tilføjelse af Bortezomib til den anden transplantation vil øge chancerne for at blive i remission længere.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- John Theurer Cancer Center @ Hackensack University Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Ændret fra: Inklusionskriterier:
- Bekræftet diagnose af myelomatose med enten Durie-Salmon stadium I, II eller III eller ISS stadium I, II eller III, mindre end 12 måneder siden påbegyndelse af systemisk behandling
- ≥8x106 CD34+celler/kg tilgængelig i kryokonservering i alikvoter passende til tandemtransplantationer
- Alder: 18-75 år på tidspunktet for transplantation
- KPS 70-100 %
- Restitution fra komplikationer fra tidligere behandlinger
- Køn: Der er ingen kønsbegrænsning
Ekskluderingskriterier:
- Anden diagnose end myelomatose
- Kemoterapi eller strålebehandling inden for 8 dage efter påbegyndelse af behandlingen i denne undersøgelse
- Forudgående autolog eller allogen transplantation (undtagen når de er indskrevet i denne undersøgelse)
- Ukontrollerede bakterielle, virale, svampe eller parasitære infektioner
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Tandemtransplantation med Melphalan og Bortezomib
Tandem autolog hæmatopoietisk stamcelletransplantation med melphalan efterfulgt af melphalan og bortezomib hos patienter med myelomatose
|
Bortezomib 1,6mg/m2 på dag -4 og dag -1
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
At bestemme den progressionsfrie overlevelse af patienter med myelomatose behandlet med tandemcyklusser af højdosis melphalan efterfulgt af højdosis melphalan i kombination med bortezomib med autolog HSC-transplantation.
Tidsramme: 3 år
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3 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
For at bestemme responsraten, den samlede overlevelse og regime-relaterede toksiciteter hos patienter med myelomatose behandlet med højdosis melphalan eller højdosis melphalan i kombination med bortezomib givet i tandemtransplantationer.
Tidsramme: livstid
|
livstid
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michele Donato, MD, John Theurer Cancer Center at Hackensack University Medical Center
Publikationer og nyttige links
Generelle publikationer
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Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
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
- Antineoplastiske midler
- Bortezomib
Andre undersøgelses-id-numre
- Pro00001295
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Kliniske forsøg med Bortezomib
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The First Affiliated Hospital of Soochow UniversityUkendtMyelom påvist ved laboratorietestKina
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Baylor College of MedicineMillennium Pharmaceuticals, Inc.AfsluttetProstata neoplasmerForenede Stater
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NCIC Clinical Trials GroupAfsluttet
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University Hospital, Clermont-FerrandLaboratoires TakedaUkendtMyelomatose | Voksen | Bortezomib-regimenFrankrig
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National Cancer Institute (NCI)AfsluttetGastrointestinal kræft | Avanceret primær leverkræft hos voksne | Lokaliseret ikke-operabel primær leverkræft hos voksne | Tilbagevendende primær leverkræft hos voksne | Tilbagevendende ekstrahepatisk galdevejskræft | Tilbagevendende galdeblærekræft | Ikke-operabel ekstrahepatisk galdevejskræft | Ikke-operabel... og andre forholdForenede Stater
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Janssen-Cilag International NVAfsluttetMyelomatoseKalkun, Grækenland, Tjekkiet, Østrig, Tyskland, Sverige, Det Forenede Kongerige, Danmark
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University Health Network, TorontoNational Cancer Institute (NCI)AfsluttetBlærekræft | Overgangscellekræft i nyrebækkenet og urinlederenForenede Stater, Canada
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Janssen Korea, Ltd., KoreaAfsluttet
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Southwest Oncology GroupNational Cancer Institute (NCI)Afsluttet
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetLymfom | Myelodysplastiske syndromer | Leukæmi | Myelom og plasmacelle-neoplasmaForenede Stater