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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma in Relapse

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vanguard<br>(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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response 4 months | The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy | 0-4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional, biomarker, multiple myeloma, phenotypic, biophysical