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

NCT ID: NCT02997813

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Multiple Myeloma Blood Stem Cell Transplant Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor

No interventions assigned to this group

Cohort 2

All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone du Myelome

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Leleu, Dr

Role: STUDY_CHAIR

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

Denis Caillot, Dr

Role: STUDY_DIRECTOR

Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon

Eric Deconinck, Pr

Role: STUDY_DIRECTOR

Hématologie, Hôpital Jean Minjoz, CHU Besançon

Samuel Limat, Pr

Role: STUDY_DIRECTOR

Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon

Locations

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CHRU Dijon

Dijon, , France

Site Status

Centre Hospitalier Universitaire (CHU) de Limoges

Limoges, , France

Site Status

Centre Hospitalier Lyon Sud

Lyon, , France

Site Status

CHRU Hôtel Dieu

Nantes, , France

Site Status

Institut Curie Centre de Lutte Contre le Cancer (CLCC)

Paris, , France

Site Status

La Pitié Salpetriêre

Paris, , France

Site Status

Hôpital Saint-Antoine

Paris, , France

Site Status

Hôpital Robert Debré Hématologie

Reims, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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IFM2014-05

Identifier Type: -

Identifier Source: org_study_id