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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03777410

Enrollment

Registered

2018-12-17

Start date

2019-02-11

Completion date

2024-06-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma in Relapse

Keywords

functional, biomarker, multiple myeloma, phenotypic, biophysical

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results