Registry of Patients Treated With Plerixafor (Mozobil®) f... | NCT01738373

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

NCT01738373

Sponsor

Genzyme, a Sanofi Company

Status

Completed

Last Update Posted

Mar 23, 2015Estimated

Enrollment

262Actual

Phase

Not provided

Conditions

Bone Marrow / Autologous Transplants

Interventions

Plerixafor

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Nov 26, 2012

First Submission Date that Met QC Criteria

Nov 28, 2012

First Posted Date

Nov 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2015

Last Update Posted Date

Mar 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

262Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plerixafor	Drug	Plerixafor will be prescribed independently by the physician, according to usual practice.		Mozobil®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The characteristics of the patients who received treatment		13 months
Dosage of treatment		13 months
Number of CD34+ cells collected following treatment		13 months
Number of patients with the existence of one or more predictive factors of poor mobilisation		13 months
Duration of treatment		13 months
Associated treatments		13 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C088327	plerixafor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided