Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482931
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-10
Brief Title:
Bleeding in Multiple Myeloma
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Incidence and Burden of Bleeding in Multiple Myeloma Patients Receiving Thromboprophylaxis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BiMM
Brief Summary:
Background Multiple myeloma MM is a haematological malignancy characterised by uncontrolled plasma cell proliferation leading to bone damage anaemia kidney failure and hypercalcemia Venous thromboembolism VTE represents a significant concern in MM and more than 10 of patients develop a VTE The currently most used thromboprophylaxis regimens consist of either aspirin or prophylactic low molecular weight heparin LMWH The choice between the two depends on patient risk assessment according to the International Myeloma Working Group IMWG guidelines Due to the associated high VTE risk MM patients have an inherent need for thromboprophylaxis which is an essential part of their care The previous randomized controlled trials RCTs comparing aspirin with LMWH observed no major bleeding events and only one minor bleeding in the LMWH group and when comparing aspirin with LMWH and warfarin major bleeding events were observed only in three patients 14 who received aspirin Moreover six patients 27 in the aspirin group one patient 05 in the warfarin group and three patients 14 in the LMWH group experienced minor bleeding events However clinically relevant non-major bleedings CRNMBs were not reported and the follow-up varied widely between the two studies The risk-benefit ratio between the different regimens is yet unclear and it is difficult to conclude which anticoagulation should be implemented as standard of care in daily practice Moreover the current regimens namely LMWH might be perceived as burdensome by MM patients due to their subcutaneous administration Therefore it is unclear whether thromboprophylaxis represents an additional significant burden for MM patients because of the method of administration or adverse bleeding events
Main research question What is the current real-life bleeding incidence in MM patients receiving thromboprophylaxis and what is the perceived burden of thromboprophylaxis
Design including population confoundersoutcomes This prospective observational study will include newly diagnosed MM patients receiving thromboprophylaxis The International Society on Thrombosis and Haemostasis ISTH bleeding criteria and the ISTH bleeding assessment tool ISTH-BAT will be adapted to the daybook format patient friendly vocabulary and translated to Dutch Patients will be asked to record bleeding events for 6 months after starting thromboprophylaxis Incidence of bleeding events stratified per major minor and CRNMB will be calculated with death as competing risk Bleeding events in LMWH and aspirin patients will be compared with a double-sided z test for independent proportions Quality of life will be assessed with validated questionnaires Lastly incidence of VTE and arterial thrombosis AT will be calculated
Expected results In an RCT comparing LMWH with aspirin prophylaxis for a fracture of an extremity bleeding events occurred in 14 of patients receiving aspirin and 14 of patients receiving LMWH within 90 days of follow-up Since comparable doses will be used in this study we expect to see similar results
Main research question What is the current real-life bleeding incidence in MM patients receiving thromboprophylaxis and what is the perceived burden of thromboprophylaxis
Design including population confoundersoutcomes This prospective observational study will include newly diagnosed MM patients receiving thromboprophylaxis The International Society on Thrombosis and Haemostasis ISTH bleeding criteria and the ISTH bleeding assessment tool ISTH-BAT will be adapted to the daybook format patient friendly vocabulary and translated to Dutch Patients will be asked to record bleeding events for 6 months after starting thromboprophylaxis Incidence of bleeding events stratified per major minor and CRNMB will be calculated with death as competing risk Bleeding events in LMWH and aspirin patients will be compared with a double-sided z test for independent proportions Quality of life will be assessed with validated questionnaires Lastly incidence of VTE and arterial thrombosis AT will be calculated
Expected results In an RCT comparing LMWH with aspirin prophylaxis for a fracture of an extremity bleeding events occurred in 14 of patients receiving aspirin and 14 of patients receiving LMWH within 90 days of follow-up Since comparable doses will be used in this study we expect to see similar results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None