Multiple MyelomaNCT07354191
Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia
A study testing direct antiglobulin test (DAT) and Indirect antiglobulin test (IAT) in people with Multiple Myeloma, run by New Valley University at 1 site in Egypt.
Trial summary
Autoimmune hemolytic anemia (AIHA) is a highly heterogeneous disease due to increased destruction of autologous erythrocytes by autoantibodies with or without complement involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- direct antiglobulin test (DAT) and Indirect antiglobulin test (IAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multiple myeloma
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- direct antiglobulin test (DAT), Indirect antiglobulin test (IAT)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct antiglobulin test (DAT)Diagnostic test
Serum sample
Indirect antiglobulin test (IAT)Diagnostic test
Serum sample
| Study group | Role | What they receive |
|---|---|---|
| MM patients | Experimental | the prevalence of AIHA in MM patients and determine its impact on clinical presentation and outcome of the disease Receives: Diagnostic Test: direct antiglobulin test (DAT); Diagnostic Test: Indirect antiglobulin test (IAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure prevalence of AIHA in MM patients .
Number of MM patients with AIHA
Measured: baseline
Detect impact on International Prognostic Scoring System
relation of the presence of AIHA to the scoring system of the patient
Measured: baseline
Detect impact on outcome
Number of patient with AIHA regarding in each response group CR, PR, PD
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Identify complications of AIHA IN MM
number pf complications related to AIHA in each patien
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2023
- Primary completion5 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nady Hussein, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354191
- Sponsor's protocol ID
- MAIHA
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33261023Kashyap 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.
PubMed 25244430Pacca 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.
PubMed 29150110Bird 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.
PubMed 21569004
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Multiple Myeloma Associated With Autoimmune Hemolytic Anemia: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07354191
- Acronym / sponsor ID
- MAIHA
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MM patients | Experimental | Diagnostic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of multiple myeloma
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct antiglobulin test (DAT)Serum sample | Diagnostic test | MM patients |
| Indirect antiglobulin test (IAT)Serum sample | Diagnostic test | MM patients |
Primary outcome
Measure prevalence of AIHA in MM patients .
Time frame: baseline
Number of MM patients with AIHA
Detect impact on International Prognostic Scoring System
Time frame: baseline
relation of the presence of AIHA to the scoring system of the patient
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
1 secondary outcome
Identify complications of AIHA IN MM
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33261023Barcellini 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.
- Background: PubMed 25244430Kashyap 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.
- Background: PubMed 29150110Pacca 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.
- Background: PubMed 21569004Bird 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct antiglobulin test (DAT) and Indirect antiglobulin test (IAT) in people with Multiple Myeloma, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure prevalence of AIHA in MM patients . (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354191, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.