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

NCT06888856 | Not Yet Recruiting

• 1 other identifier: 0523-24 TLV
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 5 years (duration of sample collection) plus 1 year for analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Bone Marrow, Serum, Peripheral Blood Mononuclear Cells (PBMCs), Plasma Cells (CD138+) These samples will be used for various analyses including flow cytometry, ELISA (for soluble BCMA), single-cell RNA sequencing, and genomic DNA sequencing of specific regions from myeloma cells.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): March 3, 2030
• Study Completion (Estimated): March 3, 2031
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share