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NCT01268774 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01268774
Other study ID # Melisse study
Secondary ID
Status Completed
Phase N/A
First received December 30, 2010
Last updated April 17, 2013
Start date February 2009
Est. completion date July 2011

Study information
Verified date April 2013
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 529
Est. completion date July 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Patients involved in an interventional clinical trial

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none) 4 months Yes
Secondary PE and DVT rate at 4 months and one year. Bleedings and all relevant SAE and AE at 4 months and one year. 12 months Yes
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