Risk of thromboembolism in patients with multiple myeloma treated with daratumumab: a systemic review and meta-analysis
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Updated: Dec 13, 2025

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Published on: July 15, 2015
1Department of Internal Medicine, MetroHealth Medical Center, Case Western Reserve University, 2500 MetroHealth Dr, Cleveland, OH, 44109, USA. jwang1@metrohealth.org.
Background:
Patients with multiple myeloma (MM) have increased risks of venous thromboembolism (VTE) and arterial thromboembolism (ATE). The risk of thrombosis differs among different treatment regimens. It is unknown if daratumumab could affect thrombosis risk.
Methods:
A comprehensive search was conducted until April 2020. Events of VTE, including pulmonary embolism and deep venous thrombosis, as well as events of ATE, including acute ischemic stroke and myocardial infarction, were extracted from trials. In addition, events of thrombocytopenia and gastrointestinal (GI) bleeding were also extracted.
Results:
Six trials were included in the meta-analysis. Daratumumab was associated with a lower risk of VTE compared with non-daratumumab regimen (Risk ratio [RR], 0.60; 95% confidence interval [CI], 0.40-0.91). The risk of ATE had no significant difference (RR, 0.80; 95% CI, 0.48-1.33). Daratumumab was also associated with a trend of higher risk of Grade 3/4 thrombocytopenia (RR, 1.14; 95% CI, 0.94-1.38), while the risk of GI bleeding was not significantly different (RR, 1.32; 95% CI, 0.38-4.65).
Conclusion:
Daratumumab is associated with lower risk of VTE in clinical trials.
Insights
Daratumumab treatment in multiple myeloma patients shows a reduced risk of venous thromboembolism (VTE). Arterial thromboembolism (ATE) risk remained unchanged, with a slight trend towards higher thrombocytopenia.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Multiple myeloma (MM) patients face elevated risks of venous thromboembolism (VTE) and arterial thromboembolism (ATE).
- Thrombosis risk varies significantly across different MM treatment regimens.
- The impact of daratumumab on thrombosis risk in MM is not well-established.
Purpose of the Study:
- To evaluate the effect of daratumumab on the risk of VTE and ATE in patients with multiple myeloma.
- To assess the association between daratumumab and other adverse events, including thrombocytopenia and gastrointestinal bleeding.
Main Methods:
- A systematic literature search was performed up to April 2020.
- Data on VTE (pulmonary embolism, deep venous thrombosis) and ATE (ischemic stroke, myocardial infarction) were extracted from six clinical trials.
- Incidence of thrombocytopenia and gastrointestinal bleeding was also analyzed.
Main Results:
- Daratumumab use was linked to a significantly lower risk of VTE compared to non-daratumumab regimens (RR, 0.60; 95% CI, 0.40-0.91).
- No significant difference in ATE risk was observed between groups (RR, 0.80; 95% CI, 0.48-1.33).
- A trend towards increased Grade 3/4 thrombocytopenia was noted with daratumumab (RR, 1.14; 95% CI, 0.94-1.38), while GI bleeding risk was not significantly different.
Conclusions:
- Daratumumab is associated with a reduced risk of venous thromboembolism in clinical trials involving multiple myeloma patients.
- The study did not find a significant impact of daratumumab on arterial thromboembolism risk.
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