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

Last updated: July 1, 2024
Sponsor: Travera Inc
Overall Status: Terminated

Phase

N/A

Condition

Bone Neoplasm

Lymphoproliferative Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT03777410
TRV-001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written Informed Consent provided by patient

  2. MM, with the following conditions:

(CLOSED) For patients in the Vanguard cohort

  1. Treatment naïve disease with BM clinically indicated

For patients in the RRMM cohort

  1. Relapsed/refractory disease with BM samples clinically indicated

  2. Within 4-weeks prior to initiation of 2nd-line or later therapy

  3. Patient's oncologist must be planning to change the patient's next line of treatmentto a monotherapy or combination therapy composed exclusively of drugs from thefollowing list: Bortezomib (Velcade), Carfilzomib (Kyprolis), Lenalidomide (Revlimid), Pomalidomide (Pomalyst), Cyclophosphamide (Cytoxan), Dexamethasone,Ixazomib (Ninlaro), Venetoclax (Venclexta), Selinexor (Xpovio)

Exclusion

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent

  2. Daratumumab/Elotuzumab or other antibody-based therapeutic regimens as immediatelyplanned treatment (as prior therapy is acceptable)

  3. Patient enrolled/enrolling in a clinical trial where data or specimen sharingprovisions preclude use in this study

  4. Prior exposure to CAR-T therapy

  5. Prior allogeneic stem cell transplant

  6. Has received any systemic chemotherapy or RT, including palliative, within 7 daysprior to BM biopsy

  7. Has received any Ab therapy within 4 weeks prior to BM biopsy

Study Design

Total Participants: 33
Study Start date:
February 11, 2019
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Weill Cornell Medicine - New York Presbyterian

    New York, New York 10065
    United States

    Site Not Available

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