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CompletedNCT02861287PLERIXAFORUpdated Aug 10, 2016

Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma

An observational study in Multiple Myeloma, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-10.

Sponsored by Institut Paoli-Calmettes · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.

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Conditions studied

  • Multiple Myeloma

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In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's enrollment of 60 is below the median of 145 across 482 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will retrospectively review 60 electronic health records of patients who underwent peripheral blood stem cell mobilization for Multiple Myeloma, and who failed to achieve efficient and clinically meaningful mobilization in response to a well-conducted "G-CSF alone" regimen.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
  • First mobilization attempt
  • "rhG-CSF alone" mobilization regimen
  • Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years;
  • Primary diagnosis other than MM
  • 2nd or subsequent mobilization attempt
  • Patients who previously received HDCT + autologous HSCT
  • Chemotherapy-based mobilization regimen
  • Efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 CD34+ cells/kg for every planned autologous transplantation as per institutional SOPs).
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Study cohort

    patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria

    Other: Economic evaluation

  • Historical cohort

    patients with Multiple Myeloma who underwent PBSC mobilization immediately prior to marketing authorization and clinical utilization of Plerixafor which is before December 2009 (over the 2007-2009 period)

    Other: Economic evaluation

Interventions

  • OtherEconomic evaluation
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What researchers measure

Primary outcomes

  1. Cost-effectiveness analysis

    The cost-effectiveness analysis will be performed using the collection of a transplantable graft as effectiveness criteria; the suitability of collected cell products for transplantation will be judged as per institutional criteria. Direct medical costs will be estimated by micro-costing, i.e. by measuring physical quantities (capital and labor) consumed for each patient and attributing corresponding monetary costs on the basis of average French prices. Costs (including room - inpatient and outpatient, drugs and laboratory tests) will be estimated on the basis of patients' medical records.

    Time frame: 1 year

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Study locations

1 site
  • Institut Paoli-Calmettes
    Marseille, Bouches-du Rhône 13009, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015 and a primary completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2016
First posted
Aug 10, 2016
Start
Jan 2015
Primary completionActual
Dec 2015
Last update
Aug 10, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02861287
Responsible party
Sponsor
First posted
Aug 10, 2016
Start date
Jan 2015
Primary completion
Dec 2015
Last update
Aug 10, 2016

Study contacts

Christian Chabannon, MD PhD
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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