Multiple MyelomaBCMA in MMNCT07906418
BCMA Polymorphisms in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of B cell maturation antigen (BCMA, TNFRSF17) gene polymorphisms on treatment response and survival in patients with multiple myeloma. BCMA is a member of the tumor necrosis factor receptor superfamily that is expressed on late memory B cells and all plasma cells. 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
- What is being tested?
- BCMA polymorphism analysis
- How many people
- 420 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Feb 2027
- 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 diagnosed multiple myeloma who were treated at Başakşehir Çam and Sakura City Hospital and have stored genomic DNA samples and clinical follow-up data, and healthy controls without hematological disease, malignancy, or chronic inflammatory disease.
Who may be able to join
- Patients with multiple myeloma:
- Age 18 years or older at diagnosis
- Diagnosed symptomatic multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Completion of four cycles of first-line induction therapy
- Availability of a stored genomic DNA sample of sufficient quantity and quality for next-generation sequencing
- Availability of baseline clinical data (Durie-Salmon stage, ISS stage, ECOG performance status, laboratory data) and treatment response and survival data
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- Written informed consent for the use of biological samples and clinical data for genetic research
- Healthy controls:
- Age 18 years or older
- No known hematological disease, malignancy, or chronic inflammatory or autoimmune disease
- Availability of a stored genomic DNA sample of sufficient quantity and quality for next-generation sequencing
- Written informed consent for the use of biological samples for genetic research
Who cannot join
- Diagnosis of monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, or primary AL amyloidosis without multiple myeloma
- History of another malignancy, except adequately treated non-melanoma skin cancer or carcinoma in situ
- Insufficient or degraded DNA sample, or failed sequencing quality control
- First-degree relationship with another participant already included in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Basaksehir Cam and Sakura City Hospital
Istanbul
Istemi SERIN IS SERIN, MD, 00905323172393, serinistemi@hotmail.com
About this study
Official title: The Effect of B Cell Maturation Antigen (BCMA) Polymorphisms on Treatment Response and Survival in Patients With Multiple Myeloma
The aim of this study is to investigate the effect of B cell maturation antigen (BCMA, TNFRSF17) gene polymorphisms on treatment response and survival in patients with multiple myeloma.
BCMA is a member of the tumor necrosis factor receptor superfamily that is expressed on late memory B cells and all plasma cells. Together with the B cell activating factor receptor (BAFF-R) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI), BCMA binds the ligands B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), thereby regulating the survival, maturation, and differentiation of B cells and plasma cells.
In this study, BCMA polymorphisms will be analyzed by next-generation sequencing in stored genomic DNA samples from 320 patients with multiple myeloma and 100 healthy controls. Genotype frequencies will be compared between patients and controls, and their association with response to first-line treatment, progression-free survival, and overall survival will be evaluated in patients with multiple myeloma.
Read the detailed description
Study design: This is a single-center, retrospective case-control study. Stored genomic DNA samples and clinical data of 320 patients with multiple myeloma and 100 healthy controls will be analyzed.
Clinical data: Demographic data (age and sex), Durie-Salmon stage, International Staging System (ISS) stage, Eastern Cooperative Oncology Group (ECOG) performance status, laboratory data at diagnosis, first-line treatment, response to treatment, progression-free survival (PFS), overall survival (OS), mortality, and follow-up duration will be recorded from medical records.
Treatment: All patients were considered eligible for autologous stem cell transplantation (ASCT) at diagnosis and received four cycles of induction therapy with VCD (bortezomib, cyclophosphamide, and dexamethasone). Patients achieving at least partial response proceeded to ASCT followed by lenalidomide and dexamethasone (LD) maintenance therapy. Treatment response will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
DNA isolation: Leukocytes were isolated from peripheral blood samples collected in 2-mL EDTA tubes, and genomic DNA was extracted using the Quick-DNA Miniprep Plus Kit (Zymo Research) according to the manufacturer's instructions. DNA samples have been stored at -20°C.
Genotyping: Polymorphisms in the BCMA (TNFRSF17) gene will be analyzed by next-generation sequencing (NGS).
Statistical analysis: Genotype frequencies will be compared between patients and controls using the chi-square test or Fisher's exact test, as appropriate. The association of genotypes with treatment response will be evaluated using the chi-square test. PFS and OS will be estimated using the Kaplan-Meier method and compared using the log-rank test, and hazard ratios will be calculated using Cox regression analysis.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA polymorphism analysis
- Keywords
- B-cell maturation antigen, TNFRSF17, genetic polymorphism, next-generation sequencing, treatment response, survival
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA polymorphism analysisGenetic
Genetic: BCMA polymorphism analysis
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma patients | Patients with newly diagnosed multiple myeloma who received first-line induction therapy and have stored genomic DNA samples and clinical follow-up data Receives: Genetic: BCMA polymorphism analysis | |
| Healthy Controls | Healthy individuals without hematological disease, malignancy, or chronic inflammatory or autoimmune disease Receives: Genetic: BCMA polymorphism analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving partial response or better after first-line induction therapy, by BCMA genotype
Treatment response will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. Patients achieving complete response, very good partial response, or partial response will be classified as responders, and those with stable or progressive disease as non-responders. The percentage of responders will be compared across BCMA (TNFRSF17) genotypes determined by next-generation sequencing.
Measured: After 4 cycles of induction therapy (approximately 16 weeks from the start of treatment)
Secondary outcomes (3)
Progression-free survival (PFS) by BCMA genotype
PFS is defined as the time from diagnosis to documented disease progression according to IMWG criteria or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method, reported in months, and compared across BCMA (TNFRSF17) genotypes using the log-rank test.
Measured: From diagnosis to disease progression or death, assessed up to 144 months
Overall survival (OS) by BCMA genotype
OS is defined as the time from diagnosis to death from any cause. OS will be estimated using the Kaplan-Meier method, reported in months, and compared across BCMA (TNFRSF17) genotypes using the log-rank test.
Measured: From diagnosis to death from any cause, assessed up to 144 months
Frequency of BCMA genotypes in patients with multiple myeloma and healthy controls
Genotype frequencies of BCMA (TNFRSF17) polymorphisms, determined by next-generation sequencing, will be reported as the percentage of participants with each genotype and compared between patients with multiple myeloma and healthy controls.
Measured: At enrollment (single genotyping assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Feb 2027 (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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906418
- Sponsor's protocol ID
- 64007957MMY0002
- Other IDs
- 957-I-24-TUR-001-V02
- Acronym
- BCMA in MM
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of B Cell Maturation Antigen (BCMA) Polymorphisms on Treatment Response and Survival in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07906418
- Acronym / sponsor ID
- BCMA in MM / 64007957MMY0002
- Conditions
- Multiple Myeloma
- Keywords
- B-cell maturation antigen, TNFRSF17, genetic polymorphism, next-generation sequencing, treatment response, survival
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 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.
The aim of this study is to investigate the effect of B cell maturation antigen (BCMA, TNFRSF17) gene polymorphisms on treatment response and survival in patients with multiple myeloma.
BCMA is a member of the tumor necrosis factor receptor superfamily that is expressed on late memory B cells and all plasma cells. Together with the B cell activating factor receptor (BAFF-R) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI), BCMA binds the ligands B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), thereby regulating the survival, maturation, and differentiation of B cells and plasma cells.
In this study, BCMA polymorphisms will be analyzed by next-generation sequencing in stored genomic DNA samples from 320 patients with multiple myeloma and 100 healthy controls. Genotype frequencies will be compared between patients and controls, and their association with response to first-line treatment, progression-free survival, and overall survival will be evaluated in patients with multiple myeloma.
Detailed description
Study design: This is a single-center, retrospective case-control study. Stored genomic DNA samples and clinical data of 320 patients with multiple myeloma and 100 healthy controls will be analyzed.
Clinical data: Demographic data (age and sex), Durie-Salmon stage, International Staging System (ISS) stage, Eastern Cooperative Oncology Group (ECOG) performance status, laboratory data at diagnosis, first-line treatment, response to treatment, progression-free survival (PFS), overall survival (OS), mortality, and follow-up duration will be recorded from medical records.
Treatment: All patients were considered eligible for autologous stem cell transplantation (ASCT) at diagnosis and received four cycles of induction therapy with VCD (bortezomib, cyclophosphamide, and dexamethasone). Patients achieving at least partial response proceeded to ASCT followed by lenalidomide and dexamethasone (LD) maintenance therapy. Treatment response will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
DNA isolation: Leukocytes were isolated from peripheral blood samples collected in 2-mL EDTA tubes, and genomic DNA was extracted using the Quick-DNA Miniprep Plus Kit (Zymo Research) according to the manufacturer's instructions. DNA samples have been stored at -20°C.
Genotyping: Polymorphisms in the BCMA (TNFRSF17) gene will be analyzed by next-generation sequencing (NGS).
Statistical analysis: Genotype frequencies will be compared between patients and controls using the chi-square test or Fisher's exact test, as appropriate. The association of genotypes with treatment response will be evaluated using the chi-square test. PFS and OS will be estimated using the Kaplan-Meier method and compared using the log-rank test, and hazard ratios will be calculated using Cox regression analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma patients | – | Genetic: BCMA polymorphism analysisPatients with newly diagnosed multiple myeloma who received first-line induction therapy and have stored genomic DNA samples and clinical follow-up data |
| Healthy Controls | – | Genetic: BCMA polymorphism analysisHealthy individuals without hematological disease, malignancy, or chronic inflammatory or autoimmune disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed multiple myeloma who were treated at Başakşehir Çam and Sakura City Hospital and have stored genomic DNA samples and clinical follow-up data, and healthy controls without hematological disease, malignancy, or chronic inflammatory disease.
Key inclusion criteria (12 listed)
- Patients with multiple myeloma:
- Age 18 years or older at diagnosis
- Diagnosed symptomatic multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Completion of four cycles of first-line induction therapy
- Availability of a stored genomic DNA sample of sufficient quantity and quality for next-generation sequencing
Key exclusion criteria (4 listed)
- Diagnosis of monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, or primary AL amyloidosis without multiple myeloma
- History of another malignancy, except adequately treated non-melanoma skin cancer or carcinoma in situ
- Insufficient or degraded DNA sample, or failed sequencing quality control
- First-degree relationship with another participant already included in the study
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 |
|---|---|---|
| BCMA polymorphism analysisGenetic: BCMA polymorphism analysis | Genetic | Healthy Controls, Multiple myeloma patients |
Primary outcome
Percentage of patients achieving partial response or better after first-line induction therapy, by BCMA genotype
Time frame: After 4 cycles of induction therapy (approximately 16 weeks from the start of treatment)
Treatment response will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria. Patients achieving complete response, very good partial response, or partial response will be classified as responders, and those with stable or progressive disease as non-responders. The percentage of responders will be compared across BCMA (TNFRSF17) genotypes determined by next-generation sequencing.
3 secondary outcomes
Progression-free survival (PFS) by BCMA genotype
Time frame: From diagnosis to disease progression or death, assessed up to 144 months
Overall survival (OS) by BCMA genotype
Time frame: From diagnosis to death from any cause, assessed up to 144 months
Frequency of BCMA genotypes in patients with multiple myeloma and healthy controls
Time frame: At enrollment (single genotyping assessment)
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 30 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 12 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 30 Oct 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 Turkey (Türkiye). 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?
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 Istemi SERIN IS SERIN, MD (00905323172393, serinistemi@hotmail.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving partial response or better after first-line induction therapy, by BCMA genotype (time frame: After 4 cycles of induction therapy (approximately 16 weeks from the start of treatment)). 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 30 Oct 2026.