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

10 février 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

302

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 78 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: G-CSF plus plérixafor
Médicament: 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.
Autres noms:
  • AMD3100
  • Mozobil
Comparateur placebo: G-CSF plus placebo
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Nombre de participants avec événements indésirables
Délai: jusqu'au jour 38
Nombre de participants présentant des événements indésirables (EI) liés au traitement. Le délai pour les EI émergents du traitement est défini du jour 1 (début de la mobilisation du G-CSF) au jour précédant le début de la chimiothérapie (environ 38 jours plus tard). Les EI ont été signalés indépendamment de la relation avec le traitement à l'étude. L'investigateur a noté chaque EI à l'aide de l'échelle de notation des événements indésirables de l'Organisation mondiale de la santé (OMS). Les EI de grade 3 étaient considérés comme graves et ceux de grade 4 étaient considérés comme mettant la vie en danger.
jusqu'au jour 38
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Genzyme, a Sanofi Company

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2005

Achèvement primaire (Réel)

1 octobre 2006

Achèvement de l'étude (Réel)

1 janvier 2008

Dates d'inscription aux études

Première soumission

11 février 2005

Première soumission répondant aux critères de contrôle qualité

11 février 2005

Première publication (Estimation)

14 février 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 mars 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 février 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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