Multiple MyelomaNCT07855718
Serum Soluble BCMA as a Non-Invasive Marker in Multiple Myeloma
An observational study of Multiple Myeloma, run by Assiut University.
Trial summary
This prospective study aims to investigate serum soluble B-cell maturation antigen (sBCMA) as a non-invasive marker in patients with multiple myeloma and to compare its levels with healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 10 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with multiple myeloma and healthy controls attending South Egypt Cancer Institute, Assiut University.
Who may be able to join
- Group 1 (Newly Diagnosed MM):
- Age 18 years or older
- Newly diagnosed multiple myeloma according to WHO 2022 criteria
- Pretreatment at time of sample collection
- Group 2 (Relapsed/Refractory MM):
- Age 18 years or older
Show all 11Show fewer
- Confirmed multiple myeloma with documented relapse or refractory disease after at least one prior line of therapy
- Group 3 (Controls):
- Age 18 years or older
- Healthy volunteers with normal CBC and renal function
- Age and sex matched to patient groups
Who cannot join
- - Other active malignancies or autoimmune diseases
- Severe renal impairment (serum creatinine > 3.0 mg/dL)
- Active infection or inflammatory disease at sampling
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serum Soluble B-cell Maturation Antigen as a Non-Invasive Marker in Multiple Myeloma
This prospective study aims to investigate serum soluble B-cell maturation antigen (sBCMA) as a non-invasive marker in patients with multiple myeloma and to compare its levels with healthy controls.
Read the detailed description
Multiple myeloma is a malignant plasma cell disorder. Current monitoring relies on invasive bone marrow examination and monoclonal protein assays, which may be limited in oligosecretory disease.
This observational study will measure serum soluble BCMA levels in newly diagnosed and relapsed/refractory multiple myeloma patients and compare them with healthy controls. The relationship between sBCMA levels and clinical and laboratory disease characteristics will be assessed.
- Conditions
- Multiple Myeloma
- Keywords
- Soluble BCMA, Multiple myeloma, Non-invasive marker, Assiut
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed Multiple Myeloma | Patients with newly diagnosed multiple myeloma before initiation of treatment. | |
| Relapsed/Refractory Multiple Myeloma | Patients with relapsed or refractory multiple myeloma after at least one prior line of therapy. | |
| Healthy Controls | Age- and sex-matched healthy volunteers with normal CBC and renal function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean serum soluble BCMA level
Mean serum soluble B-cell maturation antigen (sBCMA) concentration measured by ELISA in ng/mL.
Measured: Baseline
Secondary outcomes (6)
Mean serum soluble BCMA in newly diagnosed multiple myeloma
Mean serum sBCMA level in newly diagnosed multiple myeloma patients.
Measured: Baseline
Mean serum soluble BCMA in relapsed/refractory multiple myeloma
Mean serum sBCMA level in relapsed or refractory multiple myeloma patients.
Measured: Baseline
Mean serum soluble BCMA in healthy controls
Mean serum sBCMA level in healthy control subjects.
Measured: Baseline
Mean hemoglobin level
Mean hemoglobin concentration in g/d
Measured: Baseline
Mean serum creatinine
Mean serum creatinine level in mg/dL.
Measured: Baseline
Mean bone marrow plasma cell percentage
Mean percentage of plasma cells in bone marrow aspirate.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naira Amen Ezz Eldeen Ahmed, Assiut University
- Investigators
- Hossny B Hamed, Study chair, Oncological Clinical Pathology Department South Egypt Cancer Institute, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855718
- Sponsor's protocol ID
- sBCMA-MM-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Soluble B-cell Maturation Antigen as a Non-Invasive Marker in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07855718
- Acronym / sponsor ID
- sBCMA-MM-Assiut-2026
- Conditions
- Multiple Myeloma
- Keywords
- Soluble BCMA, Multiple myeloma, Non-invasive marker, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 2 Oct 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.
This prospective study aims to investigate serum soluble B-cell maturation antigen (sBCMA) as a non-invasive marker in patients with multiple myeloma and to compare its levels with healthy controls.
Detailed description
Multiple myeloma is a malignant plasma cell disorder. Current monitoring relies on invasive bone marrow examination and monoclonal protein assays, which may be limited in oligosecretory disease.
This observational study will measure serum soluble BCMA levels in newly diagnosed and relapsed/refractory multiple myeloma patients and compare them with healthy controls. The relationship between sBCMA levels and clinical and laboratory disease characteristics will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Multiple Myeloma | – | –Patients with newly diagnosed multiple myeloma before initiation of treatment. |
| Relapsed/Refractory Multiple Myeloma | – | –Patients with relapsed or refractory multiple myeloma after at least one prior line of therapy. |
| Healthy Controls | – | –Age- and sex-matched healthy volunteers with normal CBC and renal function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma and healthy controls attending South Egypt Cancer Institute, Assiut University.
Key inclusion criteria (11 listed)
- Group 1 (Newly Diagnosed MM):
- Age 18 years or older
- Newly diagnosed multiple myeloma according to WHO 2022 criteria
- Pretreatment at time of sample collection
- Age 18 years or older
Key exclusion criteria (4 listed)
- - Other active malignancies or autoimmune diseases
- Severe renal impairment (serum creatinine > 3.0 mg/dL)
- Active infection or inflammatory disease at sampling
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean serum soluble BCMA level
Time frame: Baseline
Mean serum soluble B-cell maturation antigen (sBCMA) concentration measured by ELISA in ng/mL.
6 secondary outcomes
Mean serum soluble BCMA in newly diagnosed multiple myeloma
Time frame: Baseline
Mean serum soluble BCMA in relapsed/refractory multiple myeloma
Time frame: Baseline
Mean serum soluble BCMA in healthy controls
Time frame: Baseline
Mean hemoglobin level
Time frame: Baseline
Mean serum creatinine
Time frame: Baseline
Mean bone marrow plasma cell percentage
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hossny B Hamed study chair
Oncological Clinical Pathology Department South Egypt Cancer Institute, Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Assiut University.
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 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naira A Ezz, Resident (+20 10 10119500, amennaira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean serum soluble BCMA level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.