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Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07354191
Enrollment
66
Registered
2026-01-21
Start date
2023-01-15
Completion date
2025-11-06
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

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.

Interventions

DIAGNOSTIC_TESTdirect antiglobulin test (DAT)

Serum sample

DIAGNOSTIC_TESTIndirect antiglobulin test (IAT)

Serum sample

Sponsors

New Valley University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of multiple myeloma

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Measure prevalence of AIHA in MM patients .baselineNumber of MM patients with AIHA
Detect impact on International Prognostic Scoring Systembaselinerelation of the presence of AIHA to the scoring system of the patient
Detect impact on outcomethrough study completion, an average of 1 yearNumber of patient with AIHA regarding in each response group CR, PR, PD

Secondary

MeasureTime frameDescription
Identify complications of AIHA IN MMthrough study completion, an average of 1 yearnumber pf complications related to AIHA in each patien

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026