Clinical Trials Directory

Trials / Completed

CompletedNCT01110135

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

A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
43 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well giving bendamustine hydrochloride, etoposide, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving chemotherapy, such as bendamustine hydrochloride, etoposide, 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 filgrastim, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored

Detailed description

PRIMARY OBJECTIVES: I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF (filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs) (as determined by collecting a minimum of 2 x 10\^6 cluster of differentiation (CD)34+/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 ideally \>= 5 x 10\^6 CD34+ cells/kg (when achievable). III. To assess the impact of bendamustine on B and T-lymphocyte populations in the peripheral blood (CD20+ cells, natural killer \[NK\] cells, CD4+25+ foxP3- regulatory cells, and CD8 cells). OUTLINE: Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone orally (PO) on days 1-4, and filgrastim subcutaneously (SC) beginning on day 5 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.

Conditions

Interventions

TypeNameDescription
DRUGbendamustine hydrochlorideGiven IV
DRUGdexamethasoneGiven PO
BIOLOGICALfilgrastimGiven SC
PROCEDUREleukapheresisGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
OTHERflow cytometryCorrelative studies
DRUGetoposideGiven IV

Timeline

Start date
2010-08-01
Primary completion
2013-11-01
First posted
2010-04-26
Last updated
2017-05-24
Results posted
2017-05-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01110135. Inclusion in this directory is not an endorsement.