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

Multiple Myeloma in Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777410
• Other study ID #: TRV-001
• Status: Recruiting
• Start date: February 11, 2019
• Est. completion date: January 2027

Study information

• Verified date: April 2024
• Source: Travera Inc
• Contact: Mark Stevens, Ph.D.
• Phone: 6172999784
• Email: RRMMStudy[@]travera.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Weill Cornell Medicine - New York Presbyterian	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Travera Inc	City of Hope Comprehensive Cancer Center, Dana-Farber Cancer Institute, Massachusetts General Hospital, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

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