Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia

NCT07354191 — Not applicable, Completed, 66 participants, New Valley University

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Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia: Cross-sectional Study

RegistryNCT07354191
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, screening
Enrollment66 (Actual)
SponsorNew Valley University (Other)
ConditionsMultiple Myeloma
Interventionsdirect antiglobulin test (DAT), Indirect antiglobulin test (IAT) (Diagnostic test)
Datesstart 2023-01-15, primary completion 2025-11-05, completion 2025-11-06, first posted 2026-01-21, last updated 2026-01-21
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of direct antiglobulin test (DAT) All trials of Indirect antiglobulin test (IAT)

-Summary

Autoimmune hemolytic anemia (AIHA) is a highly heterogeneous disease due to increased destruction of autologous erythrocytes by autoantibodies with or without complement involvement. Other pathogenic mechanisms include hyper-activation of cellular immune effectors, cytokine dysregulation, and ineffective marrow compensation.

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+Detailed description

AIHAs may be primary or associated with lymphoproliferative and autoimmune diseases, infections, immunodeficiencies, solid tumors, transplants, and drugs. The direct antiglobulin test is the cornerstone of diagnosis, allowing the distinction into warm forms (wAIHA), cold agglutinin disease (CAD), and other more rare forms. Multiple myeloma (MM), on the other hand, is characterized by a clonal expansion of plasma cells in bone marrow, causing bone tissue destruction, renal failure and hematopoietic suppression. Although the association of MM and anemia is common, AIHA as the anemic manifestation of MM is rare. This prospective study will be conducted to detect the presence of AIHA in MM patients and its impact on clinical presentation and outcome of the disease.

+Arms and interventions

ArmTypeInterventionsDescription
MM patientsExperimentalDiagnostic Test: direct antiglobulin test (DAT); Diagnostic Test: Indirect antiglobulin test (IAT)the prevalence of AIHA in MM patients and determine its impact on clinical presentation and outcome of the disease
  • direct antiglobulin test (DAT) (Diagnostic test): Serum sample
  • Indirect antiglobulin test (IAT) (Diagnostic test): Serum sample

+Outcome measures

Primary outcomes

  • Measure prevalence of AIHA in MM patients . [baseline]: Number of MM patients with AIHA
  • Detect impact on International Prognostic Scoring System [baseline]: relation of the presence of AIHA to the scoring system of the patient
  • Detect impact on outcome [through study completion, an average of 1 year]: Number of patient with AIHA regarding in each response group CR, PR, PD

Secondary outcomes

  • Identify complications of AIHA IN MM [through study completion, an average of 1 year]: number pf complications related to AIHA in each patien

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Clinical diagnosis of multiple myeloma

Exclusion Criteria:

* No

+Locations (1)

FacilityCityCountryStatus
Assiut UniversityAsyutEgypt

+Publications

  • Barcellini W, Zaninoni A, Giannotta JA, Fattizzo B. New Insights in Autoimmune Hemolytic Anemia: From Pathogenesis to Therapy Stage 1. J Clin Med. 2020 Nov 27;9(12):3859. doi: 10.3390/jcm9123859. PMID 33261023
  • Kashyap R, Singh A, Kumar P. Prevalence of autoimmune hemolytic anemia in multiple myeloma: A prospective study. Asia Pac J Clin Oncol. 2016 Jun;12(2):e319-22. doi: 10.1111/ajco.12230. Epub 2014 Sep 22. PMID 25244430
  • Pacca RL, Silva JBCBD, Souza KCE, Carbinatto RB. Autoimmune hemolytic anemia and hyperglobulinemia leading to the diagnosis of multiple myeloma. Rev Bras Hematol Hemoter. 2017 Oct-Dec;39(4):357-359. doi: 10.1016/j.bjhh.2017.07.005. Epub 2017 Sep 4. No abstract available. PMID 29150110
  • Bird JM, Owen RG, D'Sa S, Snowden JA, Pratt G, Ashcroft J, Yong K, Cook G, Feyler S, Davies F, Morgan G, Cavenagh J, Low E, Behrens J; Haemato-oncology Task Force of British Committee for Standards in Haematology (BCSH) and UK Myeloma Forum. Guidelines for the diagnosis and management of multiple myeloma 2011. Br J Haematol. 2011 Jul;154(1):32-75. doi: 10.1111/j.1365-2141.2011.08573.x. Epub 2011 May 14. No abstract available. PMID 21569004