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

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ClinicalTrials.gov Identifier: NCT01268774
Recruitment Status : Completed
First Posted : December 31, 2010
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease
Multiple Myeloma

Study Type : Observational
Actual Enrollment : 529 participants
Observational Model: Cohort
Official Title: Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide
Study Start Date : February 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patinets with multiple myeloma treated with thalidomide or lenalidomide
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients involved in an interventional clinical trial

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01268774     History of Changes
Other Study ID Numbers: Melisse study
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents