Status:
TERMINATED
Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
Lead Sponsor:
Travera Inc
Collaborating Sponsors:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Conditions:
Multiple Myeloma in Relapse
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03777410
Start Date
February 11 2019
End Date
June 30 2024
Last Update
July 3 2024
Active Locations (4)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Weill Cornell Medicine - New York Presbyterian
New York, New York, United States, 10065