NCT02037256|CompletedResultsDMC

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

Barbara Ann Karmanos Cancer Institute ClinicalTrials.gov

Compare

3 other identifiers

2008-134NCI-2012-01173P30CA022453

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2014

StartedJul 2011

CompletionJan 2015

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

July 1, 2011

Completed

2.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2015

Completed

6.3 years until next milestone

Results Posted

Study results publicly available

May 10, 2021

Completed

Last Updated

May 10, 2021

Status Verified

April 1, 2021

Enrollment Period

3.6 years

First QC Date

January 14, 2014

Results QC Date

August 21, 2020

Last Update Submit

April 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

>= 2 Fold Increase in Circulating PBSC's
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 Outcomes (1)

Time to Neutrophil Engraftment
Up to 6 months

Study Arms (2)

A Treatment (bortezomib and filgrastim)

EXPERIMENTAL

GROUP A: Bortezomib administered in the evening after comploetion of G-CSF collection or on day 6 of mobilization with G-CSF.

Drug: bortezomibBiological: filgrastimProcedure: autologous hematopoietic stem cell transplantation

B Treatment (bortezomib and filgrastim)

EXPERIMENTAL

GROUP B: Bortexomib administered on days 4 \& day 7, before administration of filgrastim.

Drug: bortezomibBiological: filgrastimProcedure: autologous hematopoietic stem cell transplantation

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

A Treatment (bortezomib and filgrastim)B Treatment (bortezomib and filgrastim)

filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen

A Treatment (bortezomib and filgrastim)B Treatment (bortezomib and filgrastim)

autologous hematopoietic stem cell transplantationPROCEDURE

Undergo autologous hematopoietic stem cell transplantation

A Treatment (bortezomib and filgrastim)B Treatment (bortezomib and filgrastim)

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
+1 more criteria

You may not qualify if:

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 \[F\])
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Barbara Ann Karmanos Cancer Institutelead
National Cancer Institute (NCI)collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellIntraocular LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Hairy CellMultiple MyelomaWaldenstrom Macroglobulinemia

Interventions

BortezomibFilgrastimGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphomaEye NeoplasmsNeoplasms by SiteLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title: Dr. Divaya Bhutani
Organization: Barbara Ann Karmanos Cancer Institute

Study Officials

Divaya Bhutani, M.D.
Barbara Ann Karmanos Cancer Institute
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 15, 2014

Study Start

July 1, 2011

Primary Completion

January 21, 2015

Study Completion

January 21, 2015

Last Updated

May 10, 2021

Results First Posted

May 10, 2021

Record last verified: 2021-04

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

A Treatment (bortezomib and filgrastim)

B Treatment (bortezomib and filgrastim)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations