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
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 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 September 18, 2014