Evidence mapPaperPMID 39229471Full record

ArticleTherapeutic advances in medical oncology2024

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

Sara A Almansour, Mohammad A Y Alqudah, Ziad Abuhelwa, Humaid O Al-Shamsi, Ahmad Alhuraiji, Mohammad H Semreen, Yasser Bustanji, Karem H Alzoubi, Natansh D Modi, Ross A Mckinnon and 3 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02076009 phase3completednot on this map

Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2024Enrolled569ConditionsMultiple MyelomaArmsDaratumumab, Lenalidomide, Dexamethasone
NCT02136134 phase3completednot on this map

Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2024Enrolled498ConditionsMultiple MyelomaArmsDaratumumab, VELCADE (Bortezomib), Dexamethasone
NCT02252172 phase3completednot on this map

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2024Enrolled737ConditionsMultiple MyelomaArmsDaratumumab IV, Lenalidomide, Dexamethasone, Daratumumab SC
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Sara A AlmansourDepartment of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Mohammad A Y AlqudahDepartment of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Ziad AbuhelwaDepartment of Hematology and Medical Oncology, University of South Florida/H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Humaid O Al-ShamsiDepartment of Oncology, Burjeel Cancer Institute, Burjeel Medical City, Abu Dhabi, United Arab Emirates.
Ahmad AlhuraijiDepartment of Haematology, Kuwait Cancer Control Center, Kuwait.
Mohammad H SemreenResearch Institute of Medical and Health Sciences, University of Sharjah, Sharjah, United Arab Emirates.
Yasser BustanjiCollege of Medicine, University of Sharjah, Sharjah, United Arab Emirates.
Karem H AlzoubiDepartment of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.
Natansh D ModiCollege of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Ross A MckinnonCollege of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Michael J SorichCollege of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Ashley M HopkinsCollege of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Ahmad Y AbuhelwaDepartment of Pharmacy Practice and Pharmacotherapeutics, University of Sharjah, Sharjah, United Arab Emirates.ORCID https://orcid.org/0000-0002-4182-065X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: 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: 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: A posthoc analysis of individual-participant level data (IPD). Methods: 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: 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: 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: MAIA (NCT02252172), POLLUX (NCT02076009), CASTOR (NCT02136134).

Indexed as

antithromboticsimmunomodulatory drugs (IMiDs)multiple myelomasurvival outcomesvenous thromboembolism

Identifiers

PMID39229471
PMCPMC11369879

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.