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

NCT01268774 | Completed DMC

• 1 other identifier: Melisse study
• Study Type: observational
• Target: 529
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none)

  4 months

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patinets with multiple myeloma treated with thalidomide or lenalidomide

You may qualify if:

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

You may not qualify if:

• Patients involved in an interventional clinical trial

Sponsors & Collaborators

• LEO Pharma: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 18, 2013

Record last verified: 2013-04