Multiple Myeloma (MM)MMOMICSNCT06888856
Multiple Myeloma is a Hematologic Malignancy Characterized by the Accumulation of Malignant Plasma Cells in the Bone Marrow. Despite Advances in Treatment, Many Patients Experience Disease Relapse. Bispecific Antibodies Offer an Innovative Therapeutic Approach, But Approximately 30%-40% of Patients
An observational study of Multiple Myeloma (MM), run by Tel-Aviv Sourasky Medical Center.
Trial summary
This prospective, non-interventional study aims to characterize the molecular and cellular mechanisms underlying the response and resistance of multiple myeloma (MM) patients to bispecific antibodies (BisAb) and CAR-T therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2025to 3 Mar 2031
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of up to 200 adults diagnosed with Multiple Myeloma who are receiving or have received bispecific antibodies or CAR-T therapies. Participants will provide bone marrow and blood samples to study treatment response and resistance mechanisms. Participants must consent to data collection regarding their disease and treatment history.
Who may be able to join
- Diagnosed with multiple myeloma Candidate for BisAb, CAR-T, or other myeloma therapy Mentally competent and able to sign informed consent
Who cannot join
- Unable to undergo bone marrow sampling Pregnant women Minors (<18), incapacitated, or legally incompetent
About this study
Official title: Observational Study on Genomic and Proteomic Mechanisms in Multiple Myeloma Patients Treated With Bispecific Antibodies and CAR-T Therapies
This prospective, non-interventional study aims to characterize the molecular and cellular mechanisms underlying the response and resistance of multiple myeloma (MM) patients to bispecific antibodies (BisAb) and CAR-T therapies. Conducted at the Tel Aviv Sourasky Medical Center, the study will enroll up to 200 MM patients aged 18 and older, who are candidates for BisAb, CAR-T, or other MM treatments. Bone marrow (4-6 mL) and peripheral blood (15-20 mL) samples will be collected before treatment and at predefined intervals post-treatment, including at disease relapse/progression. The study will analyze plasma cells and the tumor microenvironment (TME) using techniques such as flow cytometry (FACS), single-cell RNA sequencing, genomic DNA sequencing, and ELISA to assess soluble BCMA levels. Key objectives include identifying genetic and protein signatures predictive of treatment response, evaluating specific drug binding, and analyzing interactions between plasma cells and immune cells (e.g., T cells). Samples will be processed and stored at the study site, with data coded to ensure patient confidentiality. Results will inform personalized treatment strategies for MM patients. The study duration includes 5 years for sample collection, 1 year for data analysis, and up to 20 years for sample storage.
Read the detailed description
The study protocol outlines a prospective, non-interventional research initiative at Tel Aviv Sourasky Medical Center to investigate molecular mechanisms of response and resistance to bispecific antibodies (BisAb) and CAR-T therapies in multiple myeloma (MM) patients. Led by Prof. Yael Cohen, the study aims to personalize treatment by analyzing bone marrow (4-6 mL) and peripheral blood (15-20 mL) samples from up to 200 MM patients aged 18+, collected pre-treatment and at specific post-treatment intervals (e.g., relapse). Key methods include flow cytometry (FACS) for drug binding and cell interactions, single-cell RNA sequencing and genomic DNA sequencing for genetic profiling, and ELISA for soluble BCMA levels. Plasma cells and the tumor microenvironment (TME) will be characterized to identify predictive biomarkers, focusing on genes like BCMA, GPRC5D, and FcRL5. Samples will be processed and stored at the study site for up to 20 years, with strict confidentiality ensured through coding. The study spans 5 years for sample collection, 1 year for analysis, and aims to improve MM treatment outcomes through tailored therapeutic approaches.
- Conditions
- Multiple Myeloma (MM)
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between molecular/cellular characteristics and treatment response
Assessment of correlation between pre-treatment molecular and cellular characteristics (including specific drug binding, plasma cell-T cell interactions, gene expression profiles, genomic mutations in therapeutic targets, and soluble BCMA levels) and clinical response to bispecific antibody and CAR-T cell therapies in multiple myeloma patients. Samples will be collected before treatment initiation and at fixed timepoints after treatment begins, with response evaluated according to standard multiple myeloma response criteria
Measured: Up to 5 years (duration of sample collection) plus 1 year for analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 Mar 2025 (estimated)
- Primary completion3 Mar 2030 (estimated)
- Study completion3 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888856
- Sponsor's protocol ID
- 0523-24 TLV
- Other IDs
- 0523-24 TLV
- Acronym
- MMOMICS
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data (IPD) will be shared outside the hospital. All data will be securely coded and stored within the hospital's internal systems with limited access, ensuring the confidentiality and privacy of participants.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Genomic and Proteomic Mechanisms in Multiple Myeloma Patients Treated With Bispecific Antibodies and CAR-T Therapies
- ClinicalTrials.gov ID
- NCT06888856
- Acronym / sponsor ID
- MMOMICS / 0523-24 TLV
- Conditions
- Multiple Myeloma (MM)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 19 Mar 2025 (estimated)
- Primary completion
- 3 Mar 2030 (estimated)
- Study completion
- 3 Mar 2031 (estimated)
- First posted
- 21 Mar 2025 (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, non-interventional study aims to characterize the molecular and cellular mechanisms underlying the response and resistance of multiple myeloma (MM) patients to bispecific antibodies (BisAb) and CAR-T therapies. Conducted at the Tel Aviv Sourasky Medical Center, the study will enroll up to 200 MM patients aged 18 and older, who are candidates for BisAb, CAR-T, or other MM treatments. Bone marrow (4-6 mL) and peripheral blood (15-20 mL) samples will be collected before treatment and at predefined intervals post-treatment, including at disease relapse/progression. The study will analyze plasma cells and the tumor microenvironment (TME) using techniques such as flow cytometry (FACS), single-cell RNA sequencing, genomic DNA sequencing, and ELISA to assess soluble BCMA levels. Key objectives include identifying genetic and protein signatures predictive of treatment response, evaluating specific drug binding, and analyzing interactions between plasma cells and immune cells (e.g., T cells). Samples will be processed and stored at the study site, with data coded to ensure patient confidentiality. Results will inform personalized treatment strategies for MM patients. The study duration includes 5 years for sample collection, 1 year for data analysis, and up to 20 years for sample storage.
Detailed description
The study protocol outlines a prospective, non-interventional research initiative at Tel Aviv Sourasky Medical Center to investigate molecular mechanisms of response and resistance to bispecific antibodies (BisAb) and CAR-T therapies in multiple myeloma (MM) patients. Led by Prof. Yael Cohen, the study aims to personalize treatment by analyzing bone marrow (4-6 mL) and peripheral blood (15-20 mL) samples from up to 200 MM patients aged 18+, collected pre-treatment and at specific post-treatment intervals (e.g., relapse). Key methods include flow cytometry (FACS) for drug binding and cell interactions, single-cell RNA sequencing and genomic DNA sequencing for genetic profiling, and ELISA for soluble BCMA levels. Plasma cells and the tumor microenvironment (TME) will be characterized to identify predictive biomarkers, focusing on genes like BCMA, GPRC5D, and FcRL5. Samples will be processed and stored at the study site for up to 20 years, with strict confidentiality ensured through coding. The study spans 5 years for sample collection, 1 year for analysis, and aims to improve MM treatment outcomes through tailored therapeutic approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of up to 200 adults diagnosed with Multiple Myeloma who are receiving or have received bispecific antibodies or CAR-T therapies. Participants will provide bone marrow and blood samples to study treatment response and resistance mechanisms. Participants must consent to data collection regarding their disease and treatment history.
Key inclusion criteria (1 listed)
- Diagnosed with multiple myeloma Candidate for BisAb, CAR-T, or other myeloma therapy Mentally competent and able to sign informed consent
Key exclusion criteria (1 listed)
- Unable to undergo bone marrow sampling Pregnant women Minors (<18), incapacitated, or legally incompetent
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
Correlation between molecular/cellular characteristics and treatment response
Time frame: Up to 5 years (duration of sample collection) plus 1 year for analysis
Assessment of correlation between pre-treatment molecular and cellular characteristics (including specific drug binding, plasma cell-T cell interactions, gene expression profiles, genomic mutations in therapeutic targets, and soluble BCMA levels) and clinical response to bispecific antibody and CAR-T cell therapies in multiple myeloma patients. Samples will be collected before treatment initiation and at fixed timepoints after treatment begins, with response evaluated according to standard multiple myeloma response criteria
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 21 Mar 2025.
- Individual participant dataSharing planned: No. No individual patient data (IPD) will be shared outside the hospital. All data will be securely coded and stored within the hospital's internal systems with limited access, ensuring the confidentiality and privacy of participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma (MM), run by Tel-Aviv Sourasky Medical Center.
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: opening soon, as of the sponsor's last update on 21 Mar 2025. 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?
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?
Correlation between molecular/cellular characteristics and treatment response (time frame: Up to 5 years (duration of sample collection) plus 1 year for analysis). 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 21 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.