Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia

January 20, 2026 updated by: Asmaa Nady Hussein, New Valley University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of multiple myeloma

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MM patients
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)
Serum sample
Diagnostic test: Indirect antiglobulin test (IAT)
Serum sample

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify complications of AIHA IN MM
Time Frame: through study completion, an average of 1 year
number pf complications related to AIHA in each patien
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

November 5, 2025

Study Completion (Actual)

November 6, 2025

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAIHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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