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Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma

NCT03777410 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2024-07-03

No results posted yet for this study

Summary

This study will collect bone marrow (BM) aspirate samples from patients with relapsed refractory multiple myeloma (RRMM) prior to the start of a new treatment regimen for the purposes of prospectively measuring single-cell mass accumulation rate (MAR) as a biomarker of patient response to that regimen.

The primary study objective is to explore whether the single-cell MAR biomarker can predict patient response in RRMM patients. In order to enable this primary objective, two patient cohorts will be required. First, a small vanguard cohort of patients with treatment naïve disease to define drug concentrations used for testing, and second, the main RRMM patient cohort. Data will be collected to estimate the biomarker's predictive properties (accuracy, sensitivity, specificity), and to support improvement of the MAR biomarker through additional research and discovery within the study dataset.

Conditions

  • Multiple Myeloma in Relapse

Sponsors & Collaborators

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • City of Hope Comprehensive Cancer Center

    collaborator OTHER

  • Travera Inc

    lead INDUSTRY

Principal Investigators

  • Nikhil C Munshi, M.D. · Dana-Farber Cancer Institute

  • Cara Rosenbaum, M.D. · Weill Medical College of Cornell University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777410 on ClinicalTrials.gov