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

Overview

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.

SparkCures ID 1037
Trial Phase Observational Trial
Enrollment 110 Patients
Trial Sponsors
  • Travera LLC
Trial Collaborators
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Weill Medical Medicine
  • Icahn School of Medicine at Mount Sinai
  • City of Hope Medical Center
NCT Identifier

NCT03777410

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Written Informed Consent provided by patient
  2. MM, with the following conditions:

i. For patients in the Vanguard cohort

1. Treatment naïve disease with BM clinically indicated

ii. 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

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent
  2. Daratumumab/Elotuzumab or other antibody-based therapeutic regimens as immediately planned treatment (as prior therapy is acceptable)
  3. Clinical trial with non-commercial relapsed/refractory samples as immediately planned treatment
  4. Prior exposure to chimeric antigen receptor T-cell (CAR-T) therapy
  5. Prior allogeneic stem cell transplant
  6. Has received any systemic chemotherapy or radiation therapy (RT), including palliative, within 7 days prior to BM biopsy

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California
New York

Resources

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