Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03777410 |
Recruitment Status :
Recruiting
First Posted : December 17, 2018
Last Update Posted : January 22, 2021
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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.
Condition or disease |
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Multiple Myeloma in Relapse |
Study Type : | Observational |
Estimated Enrollment : | 130 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma |
Actual Study Start Date : | February 11, 2019 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | February 2022 |

Group/Cohort |
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Vanguard
(CLOSED TO ENROLLMENT) Bone marrow (BM) from this cohort of up to 30 treatment naïve subjects with a diagnosis of multiple myeloma (MM) will first be used to define sample processing pipeline performance and optimal drug dosages before sites on the study proceed to mass accumulation rate (MAR) testing of BM from the relapsed/refractory MM (RRMM) subject cohort.
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Relapsed/Refractory MM
BM from this cohort of 100 relapsed subjects with a diagnosis of MM will be used to test the MAR assay's accuracy of condition by matching conditions tested in vitro to the patient's planned course of therapy. This is the main study cohort described in the Eligibility section.
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- Best Response 4 months [ Time Frame: 0-4 months ]The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Written Informed Consent provided by patient
- 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*
- Relapsed/refractory disease with BM samples clinically indicated
- Within 4-weeks prior to initiation of 2nd-line or later therapy
- Patient's oncologist must be planning to change the patient's next line of treatment to a monotherapy or combination therapy composed exclusively of drugs from the following list: Bortezomib (Velcade), Carfilzomib (Kyprolis), Lenalidomide (Revlimid), Pomalidomide (Pomalyst), Cyclophosphamide (Cytoxan), Dexamethasone, Ixazomib (Ninlaro), Venetoclax (Venclexta), Selinexor (Xpovio)
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)
- Patient enrolled/enrolling in a clinical trial where data or specimen sharing provisions preclude use in this study
- Prior exposure to CAR-T therapy
- Prior allogeneic stem cell transplant
- Has received any systemic chemotherapy or RT, including palliative, within 7 days prior to BM biopsy
- Has received any Ab therapy within 4 weeks prior to BM biopsy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777410
Contact: Mark Stevens, Ph.D. | 6172999784 | RRMMStudy@travera.com |
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Laurin Khan 626-218-0621 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Stephen Spivey 404-712-1739 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Alexandra Wright 617-724-5251 | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Laura Purvis 617-632-1950 | |
United States, New York | |
Icahn School of Medicine At Mount Sinai | Recruiting |
New York, New York, United States, 10029 | |
Contact: Alex Lieberman-Cribbin 212-241-7112 | |
Weill Cornell Medicine - New York Presbyterian | Recruiting |
New York, New York, United States, 10065 | |
Contact: Brielle Liotta 646-962-9336 |
Principal Investigator: | Nikhil C Munshi, M.D. | Dana-Farber Cancer Institute | |
Principal Investigator: | Cara Rosenbaum, M.D. | Weill Medical College of Cornell University |
Responsible Party: | Travera LLC |
ClinicalTrials.gov Identifier: | NCT03777410 |
Other Study ID Numbers: |
TRV-001 |
First Posted: | December 17, 2018 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
functional biomarker multiple myeloma phenotypic biophysical |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
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