Antithrombotic utilization, adverse events, and associations with treatment outcomes in multiple myeloma: pooled analysis of three clinical trials.

antithrombotics immunomodulatory drugs (IMiDs) multiple myeloma survival outcomes venous thromboembolism

Journal

Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808

Informations de publication

Date de publication:
2024
Historique:
received: 25 03 2024
accepted: 30 07 2024
medline: 4 9 2024
pubmed: 4 9 2024
entrez: 4 9 2024
Statut: epublish

Résumé

Patients with multiple myeloma (MM) are at risk of venous thromboembolism (VTE), worsened by immunomodulatory drugs. Although antithrombotics are recommended for prophylaxis, existing guidelines are suboptimal and treatment outcomes remain unclear. This study aimed to investigate adverse events, antithrombotic utilization, and their associations with survival outcomes in patients with MM initiating multi-drug immunomodulatory combinations. A posthoc analysis of individual-participant level data (IPD). IPD from three daratumumab clinical trials (MAIA, POLLUX, and CASTOR) were pooled. Adverse events incidence and antithrombotic utilization were assessed. Logistic and Cox regression were utilized to examine associations between antithrombotics use with adverse events and survival outcomes at the baseline and 6-month landmark. Among 1804 patients, VTE occurred in 10%, bleeding in 14%, ischemic heart disease in 4%, and stroke in 2%. Patients with these adverse events demonstrated elevated rates of any grade ⩾3 events. Antiplatelet (primarily aspirin) and anticoagulant (primarily LMWH and direct oral anticoagulants) prescriptions have seen an increase from baseline (25% and 14%, respectively) to 6 months (35% and 31%). The primary indication for their use was prophylaxis. Anticoagulant use within 6 months was associated with reduced VTE (OR (95% CI) = 0.45 (0.26-0.77), This study underscores the complexities of antithrombotic therapy and adverse events in MM and highlights the need for vigilant and proactive management due to increased grade ⩾3 adverse events. While anticoagulant use was associated with reduced VTE risk, further research is needed to optimize thromboprophylaxis guidelines and explore antithrombotic efficacy and safety in patients with MM. MAIA (NCT02252172), POLLUX (NCT02076009), CASTOR (NCT02136134). Blood clot prevention drugs in multiple myeloma: usage and impact on patient outcomes Aims and Purpose of the Research This study aimed to understand how blood-thinning medications are used by patients with multiple myeloma, a type of blood cancer. Specifically, we wanted to find out how often these medications are used, what side effects they might cause, and whether they are linked with how long the patients live. Background of the Research This study is important because patients with multiple myeloma often have a higher risk of blood clots, especially when they are taking certain anticancer treatments. Blood-thinning drugs are usually recommended to prevent these clots, but it’s not always clear how well these drugs work or what side effects they might cause. Methods and Research Design This study looked at data from three clinical trials involving a multiple myeloma drug called daratumumab. We looked at how often side effects occurred and how often blood-thinning drugs were used. Two groups of blood thinning drugs were investigated: antiplatelets and anticoagulants. We used two types of statistical methods, called logistic and Cox regression, to see if there was a connection between the use of these blood-thinning drugs and the occurrence of side effects or survival rates at the start of the study and after six months. Results and Importance The study found that the use of blood-thinning drugs increased over time and that using anticoagulants within the first six months was linked to a lower risk of blood clots. However, blood-thinning drugs were not linked with how long the patients lived. These results are important because they can help doctors better manage the use of blood-thinning drugs in patients with multiple myeloma. The key message is that more research is needed to improve guidelines for preventing blood clots and to better understand the safety and effectiveness of blood-thinning drugs in these patients.

Sections du résumé

Background UNASSIGNED
Patients with multiple myeloma (MM) are at risk of venous thromboembolism (VTE), worsened by immunomodulatory drugs. Although antithrombotics are recommended for prophylaxis, existing guidelines are suboptimal and treatment outcomes remain unclear.
Objectives UNASSIGNED
This study aimed to investigate adverse events, antithrombotic utilization, and their associations with survival outcomes in patients with MM initiating multi-drug immunomodulatory combinations.
Design UNASSIGNED
A posthoc analysis of individual-participant level data (IPD).
Methods UNASSIGNED
IPD from three daratumumab clinical trials (MAIA, POLLUX, and CASTOR) were pooled. Adverse events incidence and antithrombotic utilization were assessed. Logistic and Cox regression were utilized to examine associations between antithrombotics use with adverse events and survival outcomes at the baseline and 6-month landmark.
Results UNASSIGNED
Among 1804 patients, VTE occurred in 10%, bleeding in 14%, ischemic heart disease in 4%, and stroke in 2%. Patients with these adverse events demonstrated elevated rates of any grade ⩾3 events. Antiplatelet (primarily aspirin) and anticoagulant (primarily LMWH and direct oral anticoagulants) prescriptions have seen an increase from baseline (25% and 14%, respectively) to 6 months (35% and 31%). The primary indication for their use was prophylaxis. Anticoagulant use within 6 months was associated with reduced VTE (OR (95% CI) = 0.45 (0.26-0.77),
Conclusion UNASSIGNED
This study underscores the complexities of antithrombotic therapy and adverse events in MM and highlights the need for vigilant and proactive management due to increased grade ⩾3 adverse events. While anticoagulant use was associated with reduced VTE risk, further research is needed to optimize thromboprophylaxis guidelines and explore antithrombotic efficacy and safety in patients with MM.
Trial registration UNASSIGNED
MAIA (NCT02252172), POLLUX (NCT02076009), CASTOR (NCT02136134).
Blood clot prevention drugs in multiple myeloma: usage and impact on patient outcomes Aims and Purpose of the Research This study aimed to understand how blood-thinning medications are used by patients with multiple myeloma, a type of blood cancer. Specifically, we wanted to find out how often these medications are used, what side effects they might cause, and whether they are linked with how long the patients live. Background of the Research This study is important because patients with multiple myeloma often have a higher risk of blood clots, especially when they are taking certain anticancer treatments. Blood-thinning drugs are usually recommended to prevent these clots, but it’s not always clear how well these drugs work or what side effects they might cause. Methods and Research Design This study looked at data from three clinical trials involving a multiple myeloma drug called daratumumab. We looked at how often side effects occurred and how often blood-thinning drugs were used. Two groups of blood thinning drugs were investigated: antiplatelets and anticoagulants. We used two types of statistical methods, called logistic and Cox regression, to see if there was a connection between the use of these blood-thinning drugs and the occurrence of side effects or survival rates at the start of the study and after six months. Results and Importance The study found that the use of blood-thinning drugs increased over time and that using anticoagulants within the first six months was linked to a lower risk of blood clots. However, blood-thinning drugs were not linked with how long the patients lived. These results are important because they can help doctors better manage the use of blood-thinning drugs in patients with multiple myeloma. The key message is that more research is needed to improve guidelines for preventing blood clots and to better understand the safety and effectiveness of blood-thinning drugs in these patients.

Autres résumés

Type: plain-language-summary (eng)
Blood clot prevention drugs in multiple myeloma: usage and impact on patient outcomes Aims and Purpose of the Research This study aimed to understand how blood-thinning medications are used by patients with multiple myeloma, a type of blood cancer. Specifically, we wanted to find out how often these medications are used, what side effects they might cause, and whether they are linked with how long the patients live. Background of the Research This study is important because patients with multiple myeloma often have a higher risk of blood clots, especially when they are taking certain anticancer treatments. Blood-thinning drugs are usually recommended to prevent these clots, but it’s not always clear how well these drugs work or what side effects they might cause. Methods and Research Design This study looked at data from three clinical trials involving a multiple myeloma drug called daratumumab. We looked at how often side effects occurred and how often blood-thinning drugs were used. Two groups of blood thinning drugs were investigated: antiplatelets and anticoagulants. We used two types of statistical methods, called logistic and Cox regression, to see if there was a connection between the use of these blood-thinning drugs and the occurrence of side effects or survival rates at the start of the study and after six months. Results and Importance The study found that the use of blood-thinning drugs increased over time and that using anticoagulants within the first six months was linked to a lower risk of blood clots. However, blood-thinning drugs were not linked with how long the patients lived. These results are important because they can help doctors better manage the use of blood-thinning drugs in patients with multiple myeloma. The key message is that more research is needed to improve guidelines for preventing blood clots and to better understand the safety and effectiveness of blood-thinning drugs in these patients.

Identifiants

pubmed: 39229471
doi: 10.1177/17588359241275387
pii: 10.1177_17588359241275387
pmc: PMC11369879
doi:

Banques de données

ClinicalTrials.gov
['NCT02076009', 'NCT02252172', 'NCT02136134']

Types de publication

Journal Article

Langues

eng

Pagination

17588359241275387

Informations de copyright

© The Author(s), 2024.

Déclaration de conflit d'intérêts

HOA is on the advisory board of ROCHE, MSD, BMS, ASTRAZENECA, and Novartis. All other authors have no competing interests to disclose.

Auteurs

Sara A Almansour (SA)

Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.

Mohammad A Y Alqudah (MAY)

Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.

Ziad Abuhelwa (Z)

Department of Hematology and Medical Oncology, University of South Florida/H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Humaid O Al-Shamsi (HO)

Department of Oncology, Burjeel Cancer Institute, Burjeel Medical City, Abu Dhabi, United Arab Emirates.
College of Medicine, Ras Al Khaimah Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates.
Emirates Oncology Society, Dubai, United Arab Emirates.
Gulf Medical University, Ajman, United Arab Emirates.
Gulf Cancer Society, Alsafa, Kuwait.

Ahmad Alhuraiji (A)

Department of Haematology, Kuwait Cancer Control Center, Kuwait.

Mohammad H Semreen (MH)

Research Institute of Medical and Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.
Department of Medicinal Chemistry, University of Sharjah, Sharjah, United Arab Emirates.

Yasser Bustanji (Y)

College of Medicine, University of Sharjah, Sharjah, United Arab Emirates.
School of Pharmacy, The University of Jordan, Amman, Jordan.

Karem H Alzoubi (KH)

Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Research Institute of Medical and Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.

Natansh D Modi (ND)

College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Ross A Mckinnon (RA)

College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Michael J Sorich (MJ)

College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Ashley M Hopkins (AM)

College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Ahmad Y Abuhelwa (AY)

Department of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Research Institute of Medical and Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.

Classifications MeSH