To estimate the prothrombotic phenotype of patients with MM, on treatment with IMiD, using whole blood thrombin generation (WB-TG), platelet activation assays and PMC formation.
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thrombin generation in whole blood, platelet activation and platelet-monocyte
complex formation in patients with MM and in controls.
Secondary outcome
Not apllicable
Background summary
Patients with multiple myeloma (MM) have an increased risk of venous
thromboembolism (VTE). During the past decade, the introduction of oral
immunomodulatory drugs (IMiDs), like thalidomide and lenalidomide, has improved
the clinical outcome of patients diagnosed with MM. However, a high rate of
thromboembolic complications has been observed when using these agents,
especially in combination with chemotherapy and high-dose corticosteroids,
which has led to increased clinical awareness of VTE and research focus on the
topic.
Thrombin generation (TG) in platelet poor plasma (PPP) is a research tool in
the field of thrombosis and hemostasis. TG is currently the best, in vitro,
test to predict the risk of (recurrent) thrombosis. Recently, we developed an
assay to measure TG in whole blood which gives global insight in the blood
cells mediated coagulation potential. Furthermore, in patients with MM
platelets are more activated. When platelets are activated, they form complexes
with monocytes. These platelet-monocyte complexes (PMCs) represent an early
process in atherothrombosis and inflammation. Inflammation also occurs at the
endothelial level, contributing to atherosclerotic plaque formation.
Study objective
To estimate the prothrombotic phenotype of patients with MM, on treatment with
IMiD, using whole blood thrombin generation (WB-TG), platelet activation assays
and PMC formation.
Study design
A case-control study
Study burden and risks
The burden associated with the participation in this study is a venapuncture in
the arm and the subsequent collection of 21 ml of blood. The risks associated
with a venapuncture are minimal, bruising at the puncture site may occur.
Oxfordlaan 70
Maastricht 6191EV
NL
Oxfordlaan 70
Maastricht 6191EV
NL
Listed location countries
Age
Inclusion criteria
For all participants (patients and controls):
- Subjects of both gender
- Age *18
- Written informed consent from the subject
Patients with Multiple Myeloma:
- Stable condition
- Diagnosis of Multiple Myeloma
- On active treatment with IMiD
- Patient of the Meander Medical Center
Exclusion criteria
For all participants (patients and controls):
- Age below 18
- Known abnormalities of the coagulation system
- Pregnancy
- The use of anti-coagulant drugs (low molecular weight heparin (LMWH), vitamin
K antagonists (VKAs) and direct oral anticoagulants (DOACs))
- Active infection, bleeding or other systemic diseases
For controls (relatives: family or no-family):
- Active malignancy
- Personal history of bleeding or thrombotic events
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68552.068.19 |