Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies (MOZOBIL)

Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor

This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Blood Stem Cell Transplant Failure

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • CHRU DIjon
  • Limoges, France, 87042
    • Centre Hospitalier Universitaire (CHU) de Limoges
  • Lyon, France, 69495
    • Centre Hospitalier Lyon Sud
  • Nantes, France, 44035
    • CHRU Hôtel Dieu
  • Paris, France, 75571
    • Hopital Saint-Antoine
  • Paris, France, 75013
    • La Pitié Salpêtrière
  • Paris, France, 75005
    • Institut Curie Centre de Lutte Contre le Cancer (CLCC)
  • Reims, France, 51092
    • Hôpital Robert Debré Hématologie
  • Rouen, France, 76038
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

Description

Inclusion Criteria:

• Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront.
• Age > 18 years
• Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor

Exclusion Criteria:

• Age < 18 years;
• Primary diagnosis other than Multiple Myeloma

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor
Cohort 2; All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total cost of stem cell mobilization procedure (including remobilisation if applicable)	2009-2013

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of visits for administration of mobilizing agents	2009-2013
Duration (days) of administration of mobilizing agents	2009-2013
Agents used as mobilizing agents	2009-2013
Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)	2009-2013
Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)	2009-2013

Collaborators and Investigators

• Sponsor: Intergroupe Francophone du Myelome
• Investigators: Study Chair: Xavier Leleu, Dr, Service des maladies du sang, Hôpital Huriez, CHRU, Lille; Study Director: Denis Caillot, Dr, Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon; Study Director: Eric Deconinck, Pr, Hématologie, Hôpital Jean Minjoz, CHU Besançon; Study Director: Samuel Limat, Pr, Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: IFM2014-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO