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

NCT02861287 | Completed

• 1 other identifier: PLERIXAFOR-IPC 2013-002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

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.

  1 year

Study Arms (2)

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

Economic evaluation OTHER

Historical cohort; Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years;
• Primary diagnosis other than MM
• nd 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).

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cost-Benefit Analysis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Costs and Cost Analysis; Economics; Health Care Economics and Organizations

Study Officials

• Christian Chabannon, MD PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Last Updated: August 10, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)