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Bortezomib for Immunoglobulin Light Chain(AL) Amyloidosis

25. juni 2015 opdateret af: Zhi-Hong Liu, M.D.

Bortezomib With Dexamethasone as the First-line Treatment for Immunoglobulin Light Chain(AL) Amyloidosis

Although the use of bortezomib has reported efficacy in amyloid light chain (AL) amyloidosis, the role of bortezomib with dexamethasone (BD) in the first-line treatment of patients with AL amyloidosis should be determined. In this study, the investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study included patients with newly diagnosed AL amyloidosis who were treated with a BD regimen in Jinling hospital. The AL amyloidosis diagnosis was confirmed by renal biopsy, and the assessment of organ involvement were based on consensus criteria. The clinical and laboratory data were collected at the beginning of each cycle and every 3 months thereafter. The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The investigators evaluated the efficacy and safety of BD as the first-line treatment of patients with AL amyloidosis.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

72

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients from hospital，who were diagnosed AL amyloidosis by renal or other type biopsy.

Beskrivelse

Inclusion Criteria:

  • Female or male patients aged between 18 to 80 years
  • Renal or other type biopsy was used to diagnose AL amyloidosis
  • Understand and voluntarily sign an informed consent form
  • ECOG score 0-3 points
  • Adequate residual organ function

Exclusion Criteria:

  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Grade 3 sensory or grade 1 painful peripheral neuropathy
  • Known hypersensitivity to bortezomib, boron or mannitol
  • Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
  • Clinically overt multiple myeloma
  • Pregnant or nursing women.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
bortezominb and dexamethasone group
Medicin: bortezominb and dexamethasone
The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.
Andre navne:
  • Velcade

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hematologic response rate
Tidsramme: 3 months
Hematologic responses were evaluated according to the novel criteria of the International Society of Amyloidosis
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
organ response rate
Tidsramme: 12 months
organ responses were evaluated according to the novel criteria of the International Society of Amyloidosis
12 months
Overall survival
Tidsramme: From date of the start of treatment to date of death,up to 3 months
From date of the start of treatment to date of death,up to 3 months
Progression free survival
Tidsramme: From date of the start of treatment to date of disease progression,up to 3 months
From date of the start of treatment to date of disease progression,up to 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhi-Hong Liu, M.D.

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. januar 2009

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

24. juni 2015

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

30. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NJCT-1501

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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