An observational study in Multiple Myeloma, sponsored by Başakşehir Çam & Sakura City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Başakşehir Çam & Sakura City Hospital · Observational
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.
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 420 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy controls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with newly diagnosed multiple myeloma who received first-line induction therapy and have stored genomic DNA samples and clinical follow-up data
Genetic: BCMA polymorphism analysis
Healthy individuals without hematological disease, malignancy, or chronic inflammatory or autoimmune disease who have stored genomic DNA samples
Genetic: BCMA polymorphism analysis
Stored genomic DNA, previously extracted from peripheral blood leukocytes, will be analyzed for BCMA (TNFRSF17) gene polymorphisms using next-generation sequencing. No additional blood sampling or study-related intervention will be performed.
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.
Time frame: After 4 cycles of induction therapy (approximately 16 weeks from the start of treatment)
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.
Time frame: 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.
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
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.
Time frame: At enrollment (single genotyping assessment)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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