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Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

10. februar 2014 oppdatert av: Genzyme, a Sanofi Company

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Studietype

Intervensjonell

Registrering (Faktiske)

302

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006
        • City of Hope Samaritan Bone Marrow Transplant Program
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai
      • Los Angeles, California, Forente stater, 90095
        • University of California
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Rocky Mountain Cancer Center
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Yale University School of Medicine
    • Florida
      • Gainesville, Florida, Forente stater, 32611
        • University of Florida
      • Tampa, Florida, Forente stater, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
    • Indiana
      • Beech Grove, Indiana, Forente stater, 46107
        • Indiana Blood and Marrow Transplantation Center
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hosptials and Clinics
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Fairview-University Medical Center, University of Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Kansas City Cancer Center
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • The Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Forente stater, 10011
        • St. Vincent's Comprehensive Cancer Center
      • New York, New York, Forente stater, 10065
        • Memorial Sloan Kettering
      • New York, New York, Forente stater, 10032
        • New York Hospital
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University
    • Texas
      • Houston, Texas, Forente stater, 77030
        • The University of Texas MD Anderson Cancer Center
      • Lackland AFB, Texas, Forente stater, 78236
        • Wilford Hall Medical Center
      • San Antonio, Texas, Forente stater, 78229
        • Texas Transplant Institute
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • Utah Blood and Marrow Transplant Program, University of Utah
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Fred Hutchinson Cancer Research Center
  • Tyskland
      • Heidelberg, Tyskland, 69120
        • Universitätsklinikum Heidelberg,

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 til 78 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of multiple myeloma in first or second complete or partial remission
  • >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
  • Recovered from all acute toxic effects of prior chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • White Blood Cell count (WBC) > 2.5*10^9/L
  • Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
  • Platelet (PLT) > 100*10^9/L
  • Serum creatinine <=2.2 mg/dL
  • Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
  • Negative for HIV

Exclusion Criteria):

  • Failed previous stem cell collection
  • Previous stem cell transplantation
  • Brain metastases or myelomatous meningitis
  • Radiation to ≥ 50% of the pelvis
  • Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
  • Received bone-seeking radionuclides (e.g. holmium)
  • A residual acute medical condition resulting from prior chemotherapy

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: G-CSF pluss plerixafor
Legemiddel: Granulocyte colony-stimulating factor plus plerixafor
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Andre navn:
  • AMD3100
  • Mozobil
Placebo komparator: G-CSF pluss placebo
Legemiddel: Granulocyte colony-stimulating factor plus placebo
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Tidsramme: up to Day 6
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
up to Day 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med uønskede hendelser
Tidsramme: til dag 38
Antall deltakere med behandlingsoppståtte bivirkninger (AE). Tidsrammen for behandlingsoppståtte bivirkninger er definert som dag 1 (start av G-CSF-mobilisering) til dagen før oppstart av kjemoterapi (omtrent 38 dager senere). AE ble rapportert uavhengig av forhold til studiebehandling. Etterforskeren graderte hver AE ved hjelp av Verdens helseorganisasjon (WHO) Adverse Event Grading Scale. Bivirkninger av grad 3 ble ansett som alvorlige og grad 4 ble ansett som livstruende.
til dag 38
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Tidsramme: up to Day 8
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
up to Day 8
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Tidsramme: up to Day 8
Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
up to Day 8
Median Number of Days to ≥6*10^6 CD34+ Cells/kg
Tidsramme: up to Day 8
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
up to Day 8
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Tidsramme: Up to Month 13
The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
Up to Month 13
Median Number of Days to Platelet (PLT) Engraftment
Tidsramme: Up to Month 13
The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
Up to Month 13
Graft Durability at 100 Days Post Transplantation
Tidsramme: approximately Day 138
The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
approximately Day 138
Graft Durability at 6 Months Post Transplantation
Tidsramme: approximately Month 7
The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
approximately Month 7
Graft Durability at 12 Months Post Transplantation
Tidsramme: approximately Month 13
The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
approximately Month 13

Samarbeidspartnere og etterforskere

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

Sponsor

Genzyme, a Sanofi Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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

1. januar 2005

Primær fullføring (Faktiske)

1. oktober 2006

Studiet fullført (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først innsendt

11. februar 2005

Først innsendt som oppfylte QC-kriteriene

11. februar 2005

Først lagt ut (Anslag)

14. februar 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. mars 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AMD3100-3102
  • 2005-003599-39 (EudraCT-nummer)

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. .

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