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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03777410
Other study ID # TRV-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
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