Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies

Completed

• Conditions: Multiple Myeloma; Blood Stem Cell Transplant Failure

• Registration Number: NCT02997813
• Lead Sponsor: Intergroupe Francophone du Myelome

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-12
• Status Verified: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Last Update Submitted: 2016-12-16
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total cost of stem cell mobilization procedure (including remobilisation if applicable)	2009-2013

Secondary Outcome Measures

Name	Time	Method
Number of visits for administration of 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
Duration (days) of administration of mobilizing agents	2009-2013
Agents used as mobilizing agents	2009-2013

Trial Locations

Locations (9)

Hôpital Saint-Antoine; 🇫🇷 Paris, France

Institut Curie Centre de Lutte Contre le Cancer (CLCC); 🇫🇷 Paris, France

Hôpital Robert Debré Hématologie; 🇫🇷 Reims, France

La Pitié Salpetriêre; 🇫🇷 Paris, France

CHRU Hôtel Dieu; 🇫🇷 Nantes, France

CHRU Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire (CHU) de Limoges; 🇫🇷 Limoges, France

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

Centre Henri Becquerel; 🇫🇷 Rouen, France