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Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

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

Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

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)

40

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater
        • City of Hope National Medical Center
    • Indiana
      • Beech Grove, Indiana, Forente stater
        • Indiana Blood and Marrow Transplantation
    • New York
      • Rochester, New York, Forente stater
        • University of Rochester Medical Center
    • Oregon
      • Portland, Oregon, Forente stater
        • Oregon Health and Science University
    • Washington
      • Seattle, Washington, Forente stater
        • Fred Hutchinson Cancer Research Center

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 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria (Abbreviated List):

  • MM in first partial response/complete response, first relapse, or second partial/complete response
  • NHL in first or second partial or complete remission
  • NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
  • MM patients who have stable disease with < 40% bone marrow involvement
  • No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • White blood cell count (WBC) >3.0 x 10^9/L
  • Absolute neutrophil count >1.5 x 10^9/L
  • Platelet count >100 x 10^9/L

Exclusion Criteria (Abbreviated List):

  • Brain metastases or carcinomatous meningitis
  • Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
  • Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
  • Acute Infection

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Plerixafor PM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.

Called 'Cohort A' in protocol, study report and publications.
Legemiddel: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Andre navn:
  • AMD3100
  • Mozobil
Eksperimentell: Plerixafor AM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.

Called 'Cohort B' in protocol, study report and publications.
Legemiddel: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Andre navn:
  • AMD3100
  • Mozobil
Eksperimentell: Low CD34+ Count/ Plerixafor PM

Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.

Called 'Cohort C' in protocol, study report and publications.
Legemiddel: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Andre navn:
  • AMD3100
  • Mozobil
Eksperimentell: Plerixafor After Chemo

This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.

Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms.

Called 'Investigational Cohort' in protocol, study report and publications.
Legemiddel: G-CSF and plerixafor
G-CSF and plerixafor were administered as described in the treatment arms.
Andre navn:
  • AMD3100
  • Mozobil

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Tidsramme: 13 months
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
13 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall transplantasjoner der deltakerne oppnådde polymorfonukleær leukocytt (PMN) engraftment innen dag 12, men ikke senere enn dag 21 etter transplantasjon av perifer blodstamcelle (PBSC)
Tidsramme: 2 måneder
Deltakerne ble overvåket for polymorfonukleær leukocytt (PMN) engraftment i henhold til den lokale standarden for omsorg. Målet for engraftment var 12 dager etter PBSC-transplantasjon og ingen transplantasjon tok mer enn 21 dager for engraftment.
2 måneder
Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Tidsramme: Days 4-5 (first dose of plerixafor to apheresis)
The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Days 4-5 (first dose of plerixafor to apheresis)

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

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. april 2004

Primær fullføring (Faktiske)

1. juli 2006

Studiet fullført (Faktiske)

1. juli 2006

Datoer for studieregistrering

Først innsendt

4. mai 2006

Først innsendt som oppfylte QC-kriteriene

4. mai 2006

Først lagt ut (Anslag)

5. mai 2006

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

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AMD3100-2104

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