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

April 14, 2021 updated by: Divaya Bhutani, Barbara Ann Karmanos Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntary written informed consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Diagnosis of B-type NHL or with multiple myeloma and eligible for autologous transplantation
  • No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy) and 4 weeks out of Bortezomib treatment for MM
  • Karnofsky performance status of > 50%
  • The patient has recovered from all acute toxic effects of prior chemotherapy
  • White blood cell (WBC) > 3.0 x 10^9/L
  • Absolute neutrophil count > 1.5 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Serum creatinine =< 2.2
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) less than two times the upper limit of normal (ULN)
  • Total bilirubin less than two times the ULN
  • Left ventricle ejection fraction > 50% (by normal echocardiogram [ECHO] or multi gated acquisition scan [MUGA] scan)
  • Diffusing capacity of the lung for carbon monoxide (DLCO) > 50%
  • Forced vital capacity > 50% of predicted
  • Negative for human immunodeficiency virus (HIV)
  • Female subject is either post-menopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential , agree to use 2 effective methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the time of signing the informed consent form through 30 days after the last dose of Bortezomib, or agree to completely abstain from heterosexual intercourse; women of child bearing potential agree to use an approved form of contraception; male subject, even if surgically sterilized (i.e., status post-vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse for the duration of the study

Exclusion Criteria:

  • Patient has a platelet count of < 100x 10^9/L within 14 days before enrollment
  • Patient has an absolute neutrophil count of ANC <1.5 x 10^9/L within 14 days before enrollment
  • Patient has creatinine of > 2.2 MG/DL within 14 days before enrollment
  • Patient has > 1.5 x ULN total bilirubin
  • Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
  • Patient has hypersensitivity to Bortezomib, boron or mannitol
  • Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
  • Participation in clinical trials with other investigational drugs not included in this trial, within 14 days before enrollment and throughout the duration of this trial
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • A co-morbid condition which, in the view of the investigators, renders the patient at high risk for this study
  • An acute medical condition resulting from prior chemotherapy
  • Brain metastases or carcinomatous meningitis
  • Acute infection
  • Fever (temp > 38 degrees Celsius [C]/100.4 degrees Fahrenheit [F])
  • Patients of child-bearing potential unwilling to implement adequate birth control
  • Patients who have deterioration of their clinical status or laboratory parameters between the time of enrollment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician or principal investigator
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Radiation therapy within 3 weeks before randomization; enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A Treatment (bortezomib and filgrastim)
GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Drug: bortezomib
Given IV
Other Names:
  • MLN341
  • LDP 341
  • VELCADE
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous hematopoietic stem cell transplantation
EXPERIMENTAL: B Treatment (bortezomib and filgrastim)
GROUP B: Bortexomib administered on days 4 & day 7, before administration of filgrastim.
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Drug: bortezomib
Given IV
Other Names:
  • MLN341
  • LDP 341
  • VELCADE
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous hematopoietic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
>= 2 Fold Increase in Circulating PBSC's
Time Frame: Up to 6 months
Participants with >= 2 fold increase in circulating PBSC's in blood and in apheresis collections in up to 4-days collection
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Neutrophil Engraftment
Time Frame: Up to 6 months
Estimated Median Time to Neutrophil Engraftment, ANC 500
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Divaya Bhutani, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

January 21, 2015

Study Completion (ACTUAL)

January 21, 2015

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-134 (OTHER: Barbara Ann Karmanos Cancer Institute)
  • P30CA022453 (U.S. NIH Grant/Contract)
  • NCI-2012-01173 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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