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

13. oktober 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

154

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Filanesib
Legemiddel: Filgrastim, granulocytt-kolonistimulerende faktor (G-CSF); subkutan
velferdstandard
Legemiddel: Filanesib, KSP (Eg5) inhibitor; intravenous
multiple dose, single schedule

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2014

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

5. september 2017

Datoer for studieregistrering

Først innsendt

19. mars 2014

Først innsendt som oppfylte QC-kriteriene

19. mars 2014

Først lagt ut (Anslag)

20. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Avansert myelomatose

Kliniske studier på Filgrastim, granulocytt-kolonistimulerende faktor (G-CSF); subkutan

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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CROs in Saudi Arabia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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