Bleeding in Multiple Myeloma (BiMM)

June 25, 2024 updated by: University Medical Center Groningen

Incidence and Burden of Bleeding in Multiple Myeloma Patients Receiving Thromboprophylaxis

  • 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 (1.4%) who received aspirin. Moreover, six patients (2.7%) in the aspirin group, one patient (0.5%) in the warfarin group, and three patients (1.4%) 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, confounders/outcomes) 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed multiple myeloma patients with an indication for thromboprophylaxis.

Description

Inclusion Criteria:

  • Patients must be newly diagnosed with MM.
  • MM patients must be receiving thromboprophylaxis (aspirin or LMWH).
  • Patient must be willing or able to fill-in questionnaires.

Exclusion Criteria:

  • Patients objecting to the use of their data for research purposes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LMWH
Patients receiving LMWH thromboprophylaxis.
Other: Quality of life questionnaires
Patients will be asked to fill in two quality of life questionnaires: PACT-Q and EQ-5D-5L.
Aspirin
Patients receiving aspirin thromboprophylaxis.
Other: Quality of life questionnaires
Patients will be asked to fill in two quality of life questionnaires: PACT-Q and EQ-5D-5L.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative bleeding incidence with death as competing risk
Time Frame: 6 months after inclusion
Bleeding events stratified according to International Society on Thrombosis and Haemostasis (ISTH) criteria: minor bleeding, clinically relevant non-major bleeding and/or major bleeding.
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative venous thrombosis incidence with death as competing risk
Time Frame: 6 months after inclusion
VTE events incidence
6 months after inclusion
Cumulative arterial thrombosis incidence with death as competing risk
Time Frame: 6 months after inclusion
AT events incidence
6 months after inclusion
Quality of life according to the EQ-5D-5L questionnaire
Time Frame: Baseline and 6 months after inclusion
Perceived quality of life according to the EQ-5D-5L questionnaire. This questionnaire assesses quality of life on a scale of 1 to 5 (no problems to severe problems) on five dimensions, namely mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also measures overall perceived quality of life on a scale of 1 to 100 (the worst health imaginable to the best health imaginable).
Baseline and 6 months after inclusion
Therapy satisfaction according to the PACT-Q questionnaire
Time Frame: Baseline and 6 months after inclusion
Perceived anticoagulation satisfaction according to the PACT-Q questionnaire. The questionnaire evaluates treatment expectations (at baseline), convenience, burden, treatment satisfaction (all three after completion of treatment) on a scale of 1 to 5 (not at all to extremely).
Baseline and 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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