Registry of Patients Treated With Plerixafor (Mozobil®) for Haematopoietic Stem Cell Mobilization Before Autologous Transplantation

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: November 26, 2012
Last updated: March 19, 2015
Last verified: March 2015
The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.

Condition Intervention Phase
Bone Marrow / Autologous Transplants
Drug: Plerixafor
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The characteristics of the patients who received treatment [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Dosage of treatment [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Number of CD34+ cells collected following treatment [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Number of patients with the existence of one or more predictive factors of poor mobilisation [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Duration of treatment [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Associated treatments [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Plerixafor
    Plerixafor will be prescribed independently by the physician, according to usual practice.
    Other Name: Mozobil®

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The selection of the registry's participants will be based on an exhaustive request of all apheresis centers distributed in the French territory.

Inclusion Criteria:

  • Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012
  • Patients who have been informed and who have given their written consent for the access to their medical file

Exclusion Criteria:

  • Patients already included in a Plerixafor ongoing clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01738373

Marseille, France
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Sanofi ( Genzyme, a Sanofi Company ) Identifier: NCT01738373     History of Changes
Other Study ID Numbers: MOZ22510 
Study First Received: November 26, 2012
Last Updated: March 19, 2015
Health Authority: France: Direction Générale de la Santé

Keywords provided by Sanofi:
autologous stem cell transplantation
multiple myeloma

Additional relevant MeSH terms:
JM 3100
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Antiviral Agents processed this record on May 26, 2016