Precision Medicine Study

NCT ID: NCT06338150

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2026-06-30

Brief Summary

This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (total n=100; approximately 50/year). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Technologies and methodologies are developing rapidly, varying on a near daily basis which pre-empts our ability to define analysis and interpretation techniques in detail. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis (e.g., a technology that is not yet available at Mount Sinai), de-identified samples or data may be sent out to third parties for additional analysis.. All external genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians . Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the study team. This study is not intended to implement the findings on CS, only to report the results obtained to the study team.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with Multiple Myeloma

Participants who will undergo tumor biopsy for management of multiple myeloma (MM)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients must be 18 years of age at the time of registration.
• Participant must have an established diagnosis of relapsed Multiple Myeloma based on IMWG criteria, be willing to participate, and able to consent
• Participant must have a treating physician who agrees to participate in the study
• Participant will be undergoing a bone marrow biopsy or tumor biopsy as part of their standard of care.
• Patients must be willing to participate in this study and able to sign informed consent.
• Participants are not participating in any interventional clinical trial using systemic therapy directed towards control of MM.

Exclusion Criteria

• Known diagnosis of AL amyloidosis, Waldenstrom Macroglobulinemia, POEMS, or Castleman´s disease.
• Diagnosis of cancer other than myeloma or skin cancer (squamous cell or basal cell) that is ongoing or treated within the last 2 years.
• Tumor sample inadequate or unavailable for analysis (e.g., due to insufficient number of tumor cells).
• Patient will not be receiving systemic MM-directed chemotherapy/immunotherapy in the following 2 months from the time tumor biopsy is performed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Cesar Rodriguez Valdes

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cesar Rodriguez Valdes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Health System

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cesar Rodriguez Valdes, MD, PhD

Role: CONTACT

Cesar.Rodriguez@mssm.edu

(212) 241-7873

Katherine Vandris

Role: CONTACT

Katherine.Vandris@mssm.edu

Facility Contacts

Cesar Rodriguez Valdes, MD, PhD

Role: primary

Cesar.Rodriguez@mssm.edu

Katherine Vandris

Role: backup

Katherine.Vandris@mssm.edu

Other Identifiers

GCO 19-0175

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5R01CA244899

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-23-00503

Identifier Type: -

Identifier Source: org_study_id