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

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ClinicalTrials.gov Identifier: NCT01738373
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : March 23, 2015
Sponsor:
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

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
U.S. FDA Resources


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

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Ages Eligible for Study:   Child, Adult, Senior
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01738373


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

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01738373     History of Changes
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
lymphoma
multiple myeloma

Additional relevant MeSH terms:
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents