NCT01339572

Brief Summary

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4.6 years

First QC Date

April 15, 2011

Last Update Submit

July 27, 2017

Conditions

Non-Hodgkin's LymphomaMultiple Myeloma

Keywords

autologous transplantationperipheral stem cell mobilization

Outcome Measures

Primary Outcomes (1)

  • Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers

    The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.

    Day 2 of apheresis

Secondary Outcomes (3)

  • Economic impact

    Day 2 of mobilization and Day +100 after transplantation

  • Kinetics of CD34+ mobilization with early introduction of plerixafor

    On Day 1 and Day 2 of apheresis

  • Graft composition

    On Day 1 and Day 2 of apheresis

Study Arms (2)

Plerixafor

EXPERIMENTAL

All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.

Drug: PlerixaforDrug: Filgrastim

Observation

ACTIVE COMPARATOR

All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen.

Drug: Filgrastim

Interventions

PlerixaforDRUG

240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5. 2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.

Also known as: AMD3100
Plerixafor
FilgrastimDRUG

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID.

Also known as: G-CSF
ObservationPlerixafor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
  • Karnofsky Performance Status ≥ 70.
  • Age ≥ 18
  • Less than 30% involvement of marrow with disease.

You may not qualify if:

  • \> 30% marrow involvement with disease
  • Age \< 18.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Cancer Hospital at the University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinMultiple Myeloma

Interventions

plerixaforFilgrastimGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jack W Hsu, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 20, 2011

Study Start

April 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

US(1)