Clinical Trials Directory

Trials / Completed

CompletedNCT02037256

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma

A Pilot Study of Peripheral Blood Hematopoietic Stem Cell Mobilization With the Combination of Bortezomib and G-CSF in Multiple Myeloma and Non-Hodgkin's Lymphoma Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Barbara Ann Karmanos Cancer Institute · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This clinical trial studies peripheral blood hemapoietic stem cell mobilization with the combination of bortezomib and G-CSF (filgrastim) in multiple myeloma and non-Hodgkin lymphoma patients.

Detailed description

PRIMARY OBJECTIVES: I. To estimate if addition of Bortezomib to the mobilization protocol will result with an increase in the levels of circulating peripheral blood stem cells (PBSCs) by at least 2-fold in blood and in the apheresis collections in up to 4-days collection protocol. II. To assess whether time to neutrophil engraftment is 12 days or less, the historical value. SECONDARY OBJECTIVES: I. To test for co-mobilization of lymphoma or myeloma cells by bortezomib and G-CSF using real time polymerase chain reaction (PCR) for non-Hodgkin lymphoma (NHL) patients and by flow cytometry (cluster of differentiation \[CD\]38+/CD138+ cell) for multiple myeloma (MM) patients. II. To determine the effect of Bortezomib on the extent of mobilization of dendritic cells subsets, plasmacytoid dendritic cell (pDC)1 and pDC2 and DC1/DC2 ratio by flow cytometry.

Conditions

Interventions

TypeNameDescription
DRUGbortezomibGiven IV
BIOLOGICALfilgrastimGiven SC
PROCEDUREautologous hematopoietic stem cell transplantationUndergo autologous hematopoietic stem cell transplantation

Timeline

Start date
2011-07-01
Primary completion
2015-01-21
Completion
2015-01-21
First posted
2014-01-15
Last updated
2021-05-10
Results posted
2021-05-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02037256. Inclusion in this directory is not an endorsement.