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

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ClinicalTrials.gov Identifier: NCT03777410
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : January 22, 2021
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
City of Hope Comprehensive Cancer Center
Emory University
Information provided by (Responsible Party):
Travera LLC

Study Description
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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.


Condition or disease
Multiple Myeloma in Relapse

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Group/Cohort
Vanguard
(CLOSED TO ENROLLMENT) Bone marrow (BM) from this cohort of up to 30 treatment naïve subjects with a diagnosis of multiple myeloma (MM) will first be used to define sample processing pipeline performance and optimal drug dosages before sites on the study proceed to mass accumulation rate (MAR) testing of BM from the relapsed/refractory MM (RRMM) subject cohort.
Relapsed/Refractory MM
BM from this cohort of 100 relapsed subjects with a diagnosis of MM will be used to test the MAR assay's accuracy of condition by matching conditions tested in vitro to the patient's planned course of therapy. This is the main study cohort described in the Eligibility section.


Outcome Measures
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Primary Outcome Measures :
  1. Best Response 4 months [ Time Frame: 0-4 months ]
    The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777410


Contacts
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Contact: Mark Stevens, Ph.D. 6172999784 RRMMStudy@travera.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Laurin Khan    626-218-0621      
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stephen Spivey    404-712-1739      
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra Wright    617-724-5251      
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Laura Purvis    617-632-1950      
United States, New York
Icahn School of Medicine At Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Alex Lieberman-Cribbin    212-241-7112      
Weill Cornell Medicine - New York Presbyterian Recruiting
New York, New York, United States, 10065
Contact: Brielle Liotta    646-962-9336      
Sponsors and Collaborators
Travera LLC
Dana-Farber Cancer Institute
Massachusetts General Hospital
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
City of Hope Comprehensive Cancer Center
Emory University
Investigators
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Principal Investigator: Nikhil C Munshi, M.D. Dana-Farber Cancer Institute
Principal Investigator: Cara Rosenbaum, M.D. Weill Medical College of Cornell University
More Information
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Responsible Party: Travera LLC
ClinicalTrials.gov Identifier: NCT03777410    
Other Study ID Numbers: TRV-001
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Travera LLC:
functional
biomarker
multiple myeloma
phenotypic
biophysical
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases