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

10 febbraio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

302

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 78 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: G-CSF più plerixafor
Droga: 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.
Altri nomi:
  • AMD3100
  • Mobile
Comparatore placebo: G-CSF più placebo
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero di partecipanti con eventi avversi
Lasso di tempo: fino al giorno 38
Numero di partecipanti con eventi avversi emergenti dal trattamento (EA). Il periodo di tempo per gli eventi avversi emergenti dal trattamento è definito dal giorno 1 (inizio della mobilizzazione del G-CSF) al giorno prima dell'inizio della chemioterapia (circa 38 giorni dopo). Gli eventi avversi sono stati segnalati indipendentemente dalla relazione con il trattamento in studio. Lo sperimentatore ha classificato ciascun evento avverso utilizzando la scala di classificazione degli eventi avversi dell'Organizzazione mondiale della sanità (OMS). Gli eventi avversi di grado 3 sono stati considerati gravi e quelli di grado 4 sono stati considerati pericolosi per la vita.
fino al giorno 38
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genzyme, a Sanofi Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2005

Completamento primario (Effettivo)

1 ottobre 2006

Completamento dello studio (Effettivo)

1 gennaio 2008

Date di iscrizione allo studio

Primo inviato

11 febbraio 2005

Primo inviato che soddisfa i criteri di controllo qualità

11 febbraio 2005

Primo Inserito (Stima)

14 febbraio 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 marzo 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 febbraio 2014

Ultimo verificato

1 febbraio 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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