Multiple Myeloma in RelapseNCT03777410
Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
An observational study of Multiple Myeloma in Relapse, run by Travera Inc at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse
- How many people
- 33 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Feb 2019to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Weill Cornell Medicine - New York Presbyterian
New York, New York, 10065
About this study
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.
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- functional, biomarker, multiple myeloma, phenotypic, biophysical
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Response 4 months
The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy
Measured: 0-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start11 Feb 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Insufficient pace of enrollment due to changes in MM SOC practices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travera Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Weill Medical College of Cornell University, City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Nikhil C Munshi, M.D., Principal investigator, Dana-Farber Cancer InstituteCara Rosenbaum, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777410
- Sponsor's protocol ID
- TRV-001
- Status last verified
- Jul 2024
- First submitted
- 14 Dec 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03777410
- Acronym / sponsor ID
- TRV-001
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- functional, biomarker, multiple myeloma, phenotypic, biophysical
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient pace of enrollment due to changes in MM SOC practices
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Travera IncIndustry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Weill Medical College of Cornell University, City of Hope Medical Center
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's pursuing initial care for their multiple myeloma at one of the 6 study sites
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Insufficient pace of enrollment due to changes in MM SOC practices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil C Munshi, M.D. principal investigator
Dana-Farber Cancer Institute
Cara Rosenbaum, M.D. principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma in Relapse, run by Travera Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient pace of enrollment due to changes in MM SOC practices). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Response 4 months (time frame: 0-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.