Clinical trial NCT03777410: Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
Official title: Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma in Relapse
Keywords: functional
biomarker
multiple myeloma
phenotypic
biophysical
Lead sponsor: Travera Inc
Sponsor class: INDUSTRY
Collaborators: name: Dana-Farber Cancer Institute
name: Massachusetts General Hospital
name: Weill Medical College of Cornell University
name: City of Hope Comprehensive Cancer Center
First posted: 2018-12-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites

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.


Eligibility criteria: 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

Primary outcomes:
measure: Best Response 4 months
timeFrame: 0-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine - New York Presbyterian
state: New York
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nikhil C Munshi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Cara Rosenbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: