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Status:

COMPLETED

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

Lead Sponsor:

Genzyme, a Sanofi Company

Conditions:

Lymphoma, Non-Hodgkin

Multiple Myeloma

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

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 st...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00322387

    Start Date

    April 1 2004

    End Date

    July 1 2006

    Last Update

    March 13 2014

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    City of Hope National Medical Center

    Duarte, California, United States

    2

    Indiana Blood and Marrow Transplantation

    Beech Grove, Indiana, United States

    3

    University of Rochester Medical Center

    Rochester, New York, United States

    4

    Oregon Health and Science University

    Portland, Oregon, United States