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Bendamustine Hydrochloride, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

2014-08-27 03:14:12 | BioPortfolio

Summary

RATIONALE: Giving chemotherapy, such as bendamustine hydrochloride and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This phase II trial is studying how well giving bendamustine hydrochloride, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma.

Description

PRIMARY OBJECTIVES:

I. To estimate the frequency of bendamustine combined with GCSF and dexamethasone to successfully mobilize PBSCs (as determined by collecting a minimum of 2 x 10^6 CD34+/kg).

SECONDARY OBJECTIVES:

I. To evaluate the response rate to bendamustine by diagnosis using established disease-specific response criteria.

II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6 CD34+ cells/kg and > 5 x 10^6 CD34+ cells/kg (when achievable). For patients with multiple myeloma who may undergo tandem autologous SCT, > 8 x 10^6 CD34+ cells/kg will be collected (when achievable).

III. To assess the impact of bendamustine on B and T-lymphocyte populations in the peripheral blood (CD20+ cells, NK cells, CD4+25+ foxP3- regulatory cells, and CD8 cells)

OUTLINE:

Patients receive bendamustine hydrochloride IV over 60 minutes on days 1 and 2, oral dexamethasone on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until peripheral blood stem cell collection is complete.

Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.

After completion of study treatment, patients are followed for up to 5 years.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Intervention

bendamustine hydrochloride, dexamethasone, filgrastim, leukapheresis

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
19024-1024

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:12-0400

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