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

NCT02997813 | Completed

• 1 other identifier: IFM2014-05
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 9

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.

Conditions

Multiple Myeloma; Blood Stem Cell Transplant Failure

Outcome Measures

Primary Outcomes (1)

• Total cost of stem cell mobilization procedure (including remobilisation if applicable)

  2009-2013

Secondary Outcomes (5)

• 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

Study Arms (2)

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

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 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Intergroupe Francophone du Myelome: lead

Study Sites (9)

CHRU Dijon

Dijon, 21000, France

Location

Centre Hospitalier Universitaire (CHU) de Limoges

Limoges, 87042, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

CHRU Hôtel Dieu

Nantes, 44035, France

Location

Institut Curie Centre de Lutte Contre le Cancer (CLCC)

Paris, 75005, France

Location

La Pitié Salpetriêre

Paris, 75013, France

Location

Hôpital Saint-Antoine

Paris, 75571, France

Location

Hôpital Robert Debré Hématologie

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Xavier Leleu, Dr

  Service des maladies du sang, Hôpital Huriez, CHRU, Lille

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)