Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

28. december 2016 opdateret af: Vaishali Sanchorawala

A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis

RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.

PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis.
  • Determine the objective hematologic response rate in patients treated with this drug.
  • Determine amyloid organ disease response in patients treated with this drug.

Secondary

  • Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone.
  • Determine the toxicity of CC-5013 in combination with dexamethasone in these patients.

OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study.

Patients are followed annually.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

82

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Cancer Research Center at Boston Medical Center

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary systemic (AL) amyloidosis

    • Tissue amyloid deposits or positive fat aspirate

  • Meets 1 of the following criteria for AL type disease:

    • Serum or urine monoclonal protein by immunofixation electrophoresis
    • Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • SWOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • White blood count> 3,000/mm^3
  • Hemoglobin > 8 g/dL
  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior thalidomide for AL amyloidosis allowed

Chemotherapy

  • More than 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Prior steroids for AL amyloidosis allowed

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • Prior surgery allowed

Other

  • Recovered from all prior therapy

Exclusion Criteria:

  • No secondary or familial amyloidosis
  • No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
  • No prior CC-5013

Renal

  • No dialysis

Cardiovascular

  • No symptomatic cardiac arrhythmia
  • No oxygen-dependent restrictive cardiomyopathy

Other

  • No untreated or uncontrolled infection
  • No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
  • No other serious medical illness that would preclude study participation
  • No history of hypersensitivity reaction to thalidomide
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Studieplan

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

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: revlimid
lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
Medicin: dexamethasone
dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
Andre navne:
  • dexamethasonacetat
Medicin: lenalidomide
15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
Andre navne:
  • revlimid; CC-5013

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Removed From Study Treatment Due to Toxicities
Tidsramme: 1 year
1 year
Number of Patients With Hematologic Response With Single-agent CC-5013
Tidsramme: 3 months

Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.

Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.

For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.

For patients with an elevated serum free light chain assay, a reduction of 50% or more.
3 months

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Vaishali Sanchorawala

Samarbejdspartnere

Celgene Corporation

Efterforskere

  • Ledende efterforsker: David C. Seldin, MD, PhD, Boston Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 2004

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

7. september 2004

Først indsendt, der opfyldte QC-kriterier

8. september 2004

Først opslået (Skøn)

9. september 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000385687
  • BUMC-H-23235 (Anden identifikator: Boston University Medical Center IRB)
  • CELGENE-RV-AMYL-PI-003 (Andet bevillings-/finansieringsnummer: Celgene)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Abonner