NCT07354191

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable multiple-myeloma

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

November 21, 2025

Last Update Submit

January 20, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • Measure prevalence of AIHA in MM patients .

    Number of MM patients with AIHA

    baseline

  • Detect impact on International Prognostic Scoring System

    relation of the presence of AIHA to the scoring system of the patient

    baseline

  • Detect impact on outcome

    Number of patient with AIHA regarding in each response group CR, PR, PD

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Identify complications of AIHA IN MM

    through study completion, an average of 1 year

Study Arms (1)

MM patients

EXPERIMENTAL

the prevalence of AIHA in MM patients and determine its impact on clinical presentation and outcome of the disease

Diagnostic Test: direct antiglobulin test (DAT)Diagnostic Test: Indirect antiglobulin test (IAT)

Interventions

direct antiglobulin test (DAT)DIAGNOSTIC_TEST

Serum sample

MM patients
Indirect antiglobulin test (IAT)DIAGNOSTIC_TEST

Serum sample

MM patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (4)

  • 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: 33261023BACKGROUND

  • 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: 25244430BACKGROUND

  • 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: 29150110BACKGROUND

  • 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: 21569004BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Coombs Test

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hemagglutination TestsAgglutination TestsSerologic TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 21, 2026

Study Start

January 15, 2023

Primary Completion

November 5, 2025

Study Completion

November 6, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

EG(1)