Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide.

April 17, 2013 updated by: LEO Pharma

Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide

Patients with multiple myeloma have seen their survival rate strongly improved with the use of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE) up to 20%. In these conditions, a prevention of this risk can be proposed by physician with either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending the new recommendations on the management of VTED, the purpose of this study is to describe in real life conditions the management by oncologists of the thrombo embolic risk for such patients

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patinets with multiple myeloma treated with thalidomide or lenalidomide

Description

Inclusion Criteria:

  • Patients with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide

Exclusion Criteria:

  • Patients involved in an interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none)
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
PE and DVT rate at 4 months and one year. Bleedings and all relevant SAE and AE at 4 months and one year.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melisse study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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