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

Terminated

• Conditions: Multiple Myeloma in Relapse

• Registration Number: NCT03777410
• Lead Sponsor: Travera Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-17
• Study Start: 2019-02-11
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Written Informed Consent provided by patient
2. 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*

1. Relapsed/refractory disease with BM samples clinically indicated
2. Within 4-weeks prior to initiation of 2nd-line or later therapy
3. 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

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. Patient enrolled/enrolling in a clinical trial where data or specimen sharing provisions preclude use in this study
4. Prior exposure to CAR-T therapy
5. Prior allogeneic stem cell transplant
6. Has received any systemic chemotherapy or RT, including palliative, within 7 days prior to BM biopsy
7. Has received any Ab therapy within 4 weeks prior to BM biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (4)

Weill Cornell Medicine - New York Presbyterian; 🇺🇸 New York, New York, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States