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

Clinical Trial Details

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.

Key Eligibility: 

Inclusion Criteria:
MM, with the following conditions:

For patients in the Vanguard cohort

  • Treatment naïve disease with BM clinically indicated

For patients in the RRMM cohort

  • Relapsed/refractory disease with BM samples clinically indicated
  • Within 4-weeks prior to initiation of 2nd-line or later therapy
  • Proceeding onto one of the following combination therapies [bortezomib (V), carfilzomib (K), lenalidomide (R), pomalidomide (P), cyclophosphamide (C), dexamethasone (d), ixazomib (I)]: RVd, VCd, KRd, PVd, KPd, Rd, Pd, Kd, IPd, IRd, RCd, PCd, venetoclax, Vd + venetoclax, Kd + venetoclax, selinexor+d

Exclusion Criteria:

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

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1808019537

ClinicalTrials.gov:

NCT03777410

Sponsor:

TRV-001

Status

Open to Enrollment

Age Group

Adult

Sponsor