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

NCT03777410 | Terminated

• 1 other identifier: TRV-001
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Myeloma in Relapse

Keywords

functional; biomarker; multiple myeloma; phenotypic; biophysical

Outcome Measures

Primary Outcomes (1)

• Best Response 4 months

  The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy

  0-4 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Travera Inc: lead
• Dana-Farber Cancer Institute: collaborator
• Massachusetts General Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• City of Hope Comprehensive Cancer Center: collaborator

Study Sites (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Weill Cornell Medicine - New York Presbyterian

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nikhil C Munshi, M.D.

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Cara Rosenbaum, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: February 11, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)