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OpenTrials
Completed

NCT Number: NCT07354191

Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia

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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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of multiple myeloma

Exclusion criteria

  • No

Treatment and study plan

direct antiglobulin test (DAT)

Diagnostic Test

Serum sample

Indirect antiglobulin test (IAT)

Diagnostic Test

Serum sample

Primary outcomes

  1. Measure prevalence of AIHA in MM patients .

    Time frame: baseline

    Number of MM patients with AIHA

  2. Detect impact on International Prognostic Scoring System

    Time frame: baseline

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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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