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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 : February 21, 2020
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
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Travera LLC

Tracking Information
First Submitted Date December 14, 2018
First Posted Date December 17, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date February 11, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2018)
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
Original Primary Outcome Measures
 (submitted: December 14, 2018)
Best Response 4 months [ Time Frame: 0-4 months ]
The best IMWG response of each patient over 4 months of therapy
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
Official Title Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient's pursuing initial care for their multiple myeloma at one of the 7 study sites
Condition Multiple Myeloma in Relapse
Intervention Not Provided
Study Groups/Cohorts
  • Vanguard
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 19, 2020)
130
Original Estimated Enrollment
 (submitted: December 14, 2018)
110
Estimated Study Completion Date February 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Written Informed Consent provided by patient
  2. MM, with the following conditions:

*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. Proceeding onto one of the following combination therapies [bortezomib (V), carfilzomib (K), lenalidomide (R), pomalidomide (P), cyclophosphamide (C), dexamethasone (d), ixazomib (I)]: RVd, VCd, KRd, PVd, KPd, Rd, Pd, Kd, IPd, IRd, RCd, PCd, venetoclax, Vd + venetoclax, Kd + venetoclax, selinexor+d

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. Clinical trial with non-commercial relapsed/refractory samples as immediately planned treatment
  4. Prior exposure to chimeric antigen receptor T-cell (CAR-T) therapy
  5. Prior allogeneic stem cell transplant
  6. Has received any systemic chemotherapy or radiation therapy (RT), including palliative, within 7 days prior to BM biopsy
  7. Has received any Ab therapy within 4 weeks prior to BM biopsy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mark Stevens, Ph.D. 6172999784 RRMMStudy@travera.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03777410
Other Study ID Numbers TRV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Travera LLC
Study Sponsor Travera LLC
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
  • Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Nikhil C Munshi, M.D. Dana-Farber Cancer Institute
Principal Investigator: Cara Rosenbaum, M.D. Weill Medical College of Cornell University
PRS Account Travera LLC
Verification Date February 2020