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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738373
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : March 23, 2015
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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 or disease Intervention/treatment
Bone Marrow / Autologous Transplants Drug: Plerixafor

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Study Type : Observational
Actual Enrollment : 262 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

Intervention Details:
  • Drug: Plerixafor
    Plerixafor will be prescribed independently by the physician, according to usual practice.
    Other Name: Mozobil®

Primary Outcome Measures :
  1. The characteristics of the patients who received treatment [ Time Frame: 13 months ]
  2. Dosage of treatment [ Time Frame: 13 months ]
  3. Number of CD34+ cells collected following treatment [ Time Frame: 13 months ]
  4. Number of patients with the existence of one or more predictive factors of poor mobilisation [ Time Frame: 13 months ]
  5. Duration of treatment [ Time Frame: 13 months ]
  6. Associated treatments [ Time Frame: 13 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738373

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

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Responsible Party: Genzyme, a Sanofi Company Identifier: NCT01738373    
Other Study ID Numbers: MOZ22510
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
autologous stem cell transplantation
multiple myeloma
Additional relevant MeSH terms:
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Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents