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NCT Number: NCT02997813

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Dijon, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2009-2013

Secondary outcomes

  1. Number of visits for administration of mobilizing agents

    Time frame: 2009-2013

  2. Duration (days) of administration of mobilizing agents

    Time frame: 2009-2013

  3. Agents used as mobilizing agents

    Time frame: 2009-2013

  4. Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)

    Time frame: 2009-2013

  5. Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)

    Time frame: 2009-2013

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone du Myelome

Network

Registry information

Official study title

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

Acronym: MOZOBIL

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 20, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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