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

10. februar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

302

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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 78 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: G-CSF plus plerixafor
Medicin: 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 navne:
  • AMD3100
  • Mozobil
Placebo komparator: G-CSF plus placebo
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere med uønskede hændelser
Tidsramme: op til dag 38
Antal deltagere med behandlingsfremkomne bivirkninger (AE'er). Tidsrammen for behandlingsfremkaldte AE'er er defineret som dag 1 (start af G-CSF-mobilisering) til dagen før start af kemoterapi (ca. 38 dage senere). AE'er blev rapporteret uanset forholdet til undersøgelsesbehandlingen. Investigatoren bedømte hver AE ved hjælp af World Health Organization (WHO) Adverse Event Grading Scale. Bivirkninger af grad 3 blev betragtet som alvorlige og grad 4 blev betragtet som livstruende.
op 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

Samarbejdspartnere og efterforskere

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

Sponsor

Genzyme, a Sanofi Company

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

Hjælpsomme links

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 2005

Primær færdiggørelse (Faktiske)

1. oktober 2006

Studieafslutning (Faktiske)

1. januar 2008

Datoer for studieregistrering

Først indsendt

11. februar 2005

Først indsendt, der opfyldte QC-kriterier

11. februar 2005

Først opslået (Skøn)

14. februar 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

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 Myelomatose

Kliniske forsøg med Granulocyte colony-stimulating factor plus plerixafor

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner