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

Sponsor

Travera LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03777410

Collaborator

Dana-Farber Cancer Institute (Other), Massachusetts General Hospital (Other), Weill Medical College of Cornell University (Other), Icahn School of Medicine at Mount Sinai (Other), City of Hope Comprehensive Cancer Center (Other), Emory University (Other)

130

Enrollment

Locations

70.7

Anticipated Duration (Months)

21.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma in Relapse

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 11, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

Best Response 4 months [0-4 months]
The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

(CLOSED) 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
2	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
5	Icahn School of Medicine At Mount Sinai	New York	New York	United States	10029
6	Weill Cornell Medicine - New York Presbyterian	New York	New York	United States	10065

Sponsors and Collaborators

Travera LLC
Dana-Farber Cancer Institute
Massachusetts General Hospital
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
City of Hope Comprehensive Cancer Center
Emory University

Investigators

Principal Investigator: Nikhil C Munshi, M.D., Dana-Farber Cancer Institute
Principal Investigator: Cara Rosenbaum, M.D., Weill Medical College of Cornell University