MyelomaNIRVANANCT05625971
Non-invasive MRD Assessment in Multiple Myeloma
An observational study of Myeloma, run by Rajshekhar Chakraborty, MD at 1 site in United States.
Trial summary
The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- MRD Assessment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 15 Dec 2025
- 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: Patients with newly diagnosed or previously treated myeloma who are initiating a new line of therapy will be recruited.
Who may be able to join
- Adults age ≥18 years
- Patients with newly diagnosed multiple myeloma
- Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
- Expected life expectancy of greater than one year and intention to start a new line of treatment
Who cannot join
- Patients without cognitive capacity to give informed consent for participation
- Patients with contraindications to MRI, which include the following:
- Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
- Pacemaker
- Metallic implants, which would prohibit patient from undergoing MRI All subjects will be screened for any contraindication to MRI as per their guidelines at the time of patient enrollment.
- Patients must not receive granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) injection within 1 week prior to WB-DWI.
- Patients must not have been initiated on treatment prior to baseline disease assessment by bone marrow aspiration/biopsy and/or WB-DWI Up to 160 mg of dexamethasone (or equivalent) and/or 1 dose of bortezomib (+/- Cyclophosphamide-Dexamethasone) is allowed prior to disease assessment by bone marrow aspiration and WB-DWI.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.
Read the detailed description
There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.
- Conditions
- Myeloma
- Being tested
- MRD Assessment
- Keywords
- Liquid biopsy, Minimal Residual Disease (MRD), Functional imaging
- Medical subject headings
- Neoplasms, Plasma Cell, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD AssessmentOther
MRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI).
| Study group | Role | What they receive |
|---|---|---|
| Myeloma Group | Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging. Receives: Other: MRD Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of non-invasive MRD assessment
MRD assessment includes liquid biopsy and functional imaging.
Measured: 6 months
Specificity of non-invasive MRD assessment
MRD assessment includes liquid biopsy and functional imaging.
Measured: 6 months
Secondary outcomes (4)
Sensitivity of two MRD-testing algorithms
Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients
Measured: 6 months
Specificity of two MRD-testing algorithms
Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients
Measured: 6 months
Progression Free Survival
The progression-free survival (PFS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)
Measured: 2 years
Overall Survival
The overall survival (OS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start14 Sep 2022
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajshekhar Chakraborty, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hope Foundation
- Responsible party
- Sponsor-investigator, Rajshekhar Chakraborty, MD, Columbia University
- Investigators
- Chakraborty Chakraborty, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625971
- Sponsor's protocol ID
- AAAU0686
- Acronym
- NIRVANA
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05625971
- Acronym / sponsor ID
- NIRVANA / AAAU0686
- Conditions
- Myeloma
- Keywords
- Liquid biopsy, Minimal Residual Disease (MRD), Functional imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rajshekhar Chakraborty, MDUniversity, hospital or other
- Collaborators
- Hope Foundation
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 23 Nov 2022 (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.
The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.
Detailed description
There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloma Group | – | Other: MRD AssessmentPatients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed or previously treated myeloma who are initiating a new line of therapy will be recruited.
Key inclusion criteria (4 listed)
- Adults age ≥18 years
- Patients with newly diagnosed multiple myeloma
- Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
- Expected life expectancy of greater than one year and intention to start a new line of treatment
Key exclusion criteria (7 listed)
- Patients without cognitive capacity to give informed consent for participation
- Patients with contraindications to MRI, which include the following:
- Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
- Pacemaker
- Metallic implants, which would prohibit patient from undergoing MRI All subjects will be screened for any contraindication to MRI as per their guidelines at the time of patient enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRD AssessmentMRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI). | Other | Myeloma Group |
Primary outcome
Sensitivity of non-invasive MRD assessment
Time frame: 6 months
MRD assessment includes liquid biopsy and functional imaging.
Specificity of non-invasive MRD assessment
Time frame: 6 months
MRD assessment includes liquid biopsy and functional imaging.
4 secondary outcomes
Sensitivity of two MRD-testing algorithms
Time frame: 6 months
Specificity of two MRD-testing algorithms
Time frame: 6 months
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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.
Chakraborty Chakraborty, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma, run by Rajshekhar Chakraborty, MD at 1 site 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 4 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: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of non-invasive MRD assessment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Jan 2026.