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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01738373
First received: November 26, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Genzyme, a Sanofi Company:

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®
  Eligibility

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738373

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

No publications provided

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01738373     History of Changes
Other Study ID Numbers: MOZ22510
Study First Received: November 26, 2012
Last Updated: March 19, 2013
Health Authority: France: Direction Générale de la Santé

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014