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

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.

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Key information

Conditions

Multiple Myeloma (MM) Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with multiple myeloma Candidate for BisAb, CAR-T, or other myeloma therapy Mentally competent and able to sign informed consent

Exclusion criteria

Unable to undergo bone marrow sampling Pregnant women Minors (<18), incapacitated, or legally incompetent

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

Observational Study on Genomic and Proteomic Mechanisms in Multiple Myeloma Patients Treated With Bispecific Antibodies and CAR-T Therapies

Acronym: MMOMICS

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2031
First posted: Mar 21, 2025
Registry last updated: Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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