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A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)

13. oktober 2020 opdateret af: Pfizer

The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.

Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Bruxelles, Belgien
        • Institut Jules Bordet
      • Leuven, Belgien
        • Universitaire Ziekenhuizen Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • QEII Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • Kings College Hospital NHS Foundation Trust
      • London, Det Forenede Kongerige
        • Barts Health NHS Trust
      • Southhampton, Det Forenede Kongerige
        • Southhampton General Hospital
      • Surrey, Det Forenede Kongerige
        • The Royal Marsden NHS Foundation Trust
      • Wolverhampton, Det Forenede Kongerige
        • New Cross Hospital
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249
        • UAB Comprehensive Cancer Center
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Colorado Blood Cancer Institute
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale Comprehensive Cancer Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University, Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • University of Kansas Cancer Center and Medical Pavilion
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Cancer Institute
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20817
        • Center for Cancer and Blood Disorders
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Karmanos Cancer Institute
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63130
        • Washington University in St. Louis
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Nebraska Hematology Oncology, P.C.
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Medical Center
      • New York, New York, Forenede Stater, 10065
        • NY Presbyterian - Weill Cornell Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Cancer Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute
    • Washington
      • Spokane Valley, Washington, Forenede Stater, 99216
        • Cancer Care Northwest
  • Frankrig
      • Bierre-Benite Cedex, Frankrig
        • Centre Hospitalier Lyon-Sud
      • Lille Cedex, Frankrig
        • Hopital Claude Huriez
      • Marseille Cedex 9, Frankrig
        • Institut Paoli Calmettes
      • Nantes Cedex, Frankrig
        • Chu Hotel Dieu
      • Nimes Cedex 9, Frankrig
        • G.H.U Caremeau
      • Toulouse, Frankrig
        • Institut Universitaire de Cancer
      • Tours Cedex, Frankrig
        • CHU tours-Hopital Bretonneau
      • Vandoeuvre les Nancy, Frankrig
        • CHU de Nancy - Hopital de Brabois
  • Grækenland
      • Athens, Grækenland
        • General Hospital of Athens "Evangelismos"
      • Athens, Grækenland
        • University of Athens School of Medicine
  • Spanien
      • Badalona, Spanien
        • Hospital Germans Trias i Pujol
      • Barcelona, Spanien
        • Hospital Clinic de Barcelona
      • Valencia, Spanien
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spanien
        • Hospital Universitario La Fe
      • Zaragoza, Spanien
        • Hospital Quiron de Zaragoza
  • Tyskland
      • Dresden, Tyskland
        • TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I
      • Hamburg, Tyskland
        • Asklepios Kliniken Hamburg GmbH
      • Heidelberg, Tyskland
        • University Hospital Heidelberg
      • Leipzig, Tyskland
        • University Hospital Leipzig
      • Tubingen, Tyskland
        • University of Tubingen
      • Wurzburg, Tyskland
        • Julius Maximilians Universitat Wurzburg

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

Key Inclusion Criteria:

  • Patients with confirmed multiple myeloma whose treatment history must include all of the following:

    1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
    2. Received at least 2 cycles of a bortezomib-containing regimen and 2 cycles of a lenalidomide-containing regimen, unless intolerant to these agents (defined as requiring discontinuation due to toxicity).
    3. Disease refractory to a carfilzomib-containing regimen and/or a pomalidomide containing regimen. Refractory is defined as either failure to achieve a minimal response (MR) or better while on therapy, or development of progressive disease (PD) while on therapy or within 60 days from last dose of therapy.

  • Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:

    1. A monoclonal Ig (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 1.0 g/dL.
    2. Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours.
    3. Involved serum free light chain (FLC) level ≥ 10 mg/dL, provided the serum FLC ratio is abnormal.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study drug.
  • Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Prior treatment with filanesib (ARRY-520) or any other KSP inhibitor.
  • Past or current plasma cell leukemia.
  • Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
  • Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
  • Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study drug. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
  • Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
  • Any severe concurrent disease or condition (including severe graft-versus-host disease, requirement for dialysis, symptomatic congestive heart failure [New York Heart Association Class III or IV], unstable angina pectoris, cardiac arrhythmia) which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
  • Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
  • Acute active infection requiring treatment.
  • Additional criteria exist.

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: Filanesib
Medicin: Filgrastim, granulocyt-koloni-stimulerende faktor (G-CSF); subkutan
plejestandard
Medicin: Filanesib, KSP (Eg5) inhibitor; intravenous
multiple dose, single schedule

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
Tidsramme: up to 2 years
up to 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
Tidsramme: up to 2 years
up to 2 years
In all patients, assess the efficacy of the study drug in terms of duration of response.
Tidsramme: up to 2 years
up to 2 years
In all patients, assess the efficacy of the study drug in terms of progression-free survival.
Tidsramme: up to 2 years
up to 2 years
In all patients, assess the efficacy of study drug in terms of overall survival.
Tidsramme: up to 2 years
up to 2 years
In all patients, assess the safety of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Tidsramme: up to 2 years
up to 2 years
In a subset of all patients, characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentration-time profiles.
Tidsramme: 6 months
6 months
In a subset of all patients, assess the correlation between study drug exposure and changes in corrected QT interval (QTc) in terms of changes in QTc versus time-matched study drug plasma concentrations.
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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 (Faktiske)

1. maj 2014

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

5. september 2017

Datoer for studieregistrering

Først indsendt

19. marts 2014

Først indsendt, der opfyldte QC-kriterier

19. marts 2014

Først opslået (Skøn)

20. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ARRAY-520-215
  • 2014-001051-23 (EudraCT nummer)
  • C4371002 (Anden identifikator: Pfizer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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 .

Kliniske forsøg med Avanceret myelomatose

Kliniske forsøg med Filgrastim, granulocyt-koloni-stimulerende faktor (G-CSF); subkutan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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