Multiple MyelomaNCT04493411
Noninvasive Detection and Assessment of Therapy Response in Multiple Myeloma Using Whole-Body MRI
A study testing WBMRI and Positron Emission Tomography/Computed Tomography (PET/CT) in people with Multiple Myeloma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is designed to prospectively determine the sensitivity, specificity, and diagnostic accuracy of whole-body MRI (WBMRI) with Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for the detection of multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- WBMRI and Positron Emission Tomography/Computed Tomography (PET/CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 12 Apr 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients with pathologically confirmed myeloma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- For cross-sectional study, no additional required treatment schedule. For longitudinal study: Patients scheduled to undergo bone marrow biopsy (BMB) and induction therapy (or have gone through 1-2 cycles of induction therapy), followed by either bone marrow transplantation (BMT) or consolidation therapy.
- Women of child-bearing potential must agree to undergo a urine pregnancy screening to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- Subjects must not be pregnant or nursing; since pregnancy is a contraindication to administration of gadolinium-based contrast agents. Furthermore, there is a potential for congenital abnormalities and the potential to harm nursing infants, associated with FDG-PET.
- Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices and other foreign bodies.
- Known severe allergic reaction to Gadolinium-based contrast agents.
- Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to prospectively determine the sensitivity, specificity, and diagnostic accuracy of whole-body MRI (WBMRI) with Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for the detection of multiple myeloma.
Subjects will undergo WBMRI and fluorodeoxyglucose (FDG) positron emission tomography (PET) for research purposes either at one time point for cross-sectional study or at four time points for longitudinal study: baseline, prior to bone marrow transplant (BMT), prior to maintenance therapy, and post BMT. The results of these imaging procedures will be compared to standard of care whole body x-ray and bone marrow biopsy results.
Read the detailed description
Whole body magnetic resonance imaging (WBMRI) will be evaluated for detection and assessment of therapy response in multiple myeloma (MM) using a novel acquisition scheme. WBMRI with diffusion weighted imaging (DWI) has demonstrated promising preliminary results for detection and response monitoring in MM. While DWI generates high lesion-to-background contrast and excellent lesion conspicuity, it suffers from compromised image quality due to geometric distortion, particularly at 3 Tesla magnetic resonance imaging (MRI), a platform which is increasingly used in clinical practice. This disadvantage, along with high costs and patient dissatisfaction associated with long scan times, have limited wide spread adoption of WBMRI with DWI in the clinical practice.
To overcome these challenges, the investigators have developed an alternative WBMRI technique: Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for improved tumor visualization by simultaneously suppressing the confounding signals of fat and fluid throughout the body.
- Conditions
- Multiple Myeloma
- Being tested
- WBMRI, Positron Emission Tomography/Computed Tomography (PET/CT)
- Keywords
- magnetic resonance imaging, positron emission tomography
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBMRIProcedure or surgery
WBMRI will be performed either at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points.
- Baseline: (before or after 1-2 cycles of induction therapy)
- Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy)
- Between Week 24 - 36 (before starting maintenance therapy)
- Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)
Positron Emission Tomography/Computed Tomography (PET/CT)Procedure or surgery
PET/CT will be performed at at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points.
- Baseline: (before or after 1-2 cycles of induction therapy)
- Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy)
- Between Week 24 - 36 (before starting maintenance therapy)
- Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Patients with pathologically confirmed myeloma for cross-sectional study (detection) or scheduled to undergo induction therapy (or have gone 1-2 cycles of induction therapy), followed by either bone marrow transplantation or consolidation therapy for longitudinal study (therapy response assessment). Receives: Procedure: WBMRI; Procedure: Positron Emission Tomography/Computed Tomography (PET/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of lesions
Effectiveness of WBMRI DETECT for the detection of lesions in MM patients will be compared to WBMRI Diffusion Weighted Imaging (DWI). A combination of clinical MRI, whole body x-ray, FDG PET, and bone marrow biopsy will be used as the reference standard.
The number of lesions identified on WBMRI-DETECT will be compared to the number of lesions identified on WBMRI-DWI. The sensitivity and specificity of WBMRI-DETECT and WBMRI-DWI will be calculated using the reference standard.
Measured: Up to 4 years
Assessment of therapy response
Effectiveness of WBMRI for assessing therapy response will be compared to the current standard of care using FDG PET and bone marrow biopsy as the validation standard.
The percentage increase in fat fraction measured using WBMRI-DETECT and the percentage increase in apparent diffusion coefficient (ADC) measured using WBMRI-DWI will be used to assess the effectiveness of WBMRI in measuring therapy response. The percentage change in SUVmax measured on PET/CT will be used as the reference standard.
Measured: Up to 4 years
Progression Free Survival (PFS)
Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with PFS.
Measured: Up to 4 years
Overall Survival (OS)
Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with OS.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start30 Nov 2020
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Why it stopped: Funding expired before enrollment goal could be reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avneesh Chhabra, University of Texas Southwestern Medical Center
- Investigators
- Avneesh Chhabra, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493411
- Sponsor's protocol ID
- STU-2019-0834
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2020
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Detection and Assessment of Therapy Response in Multiple Myeloma Using Whole-Body MRI
- ClinicalTrials.gov ID
- NCT04493411
- Acronym / sponsor ID
- STU-2019-0834
- Conditions
- Multiple Myeloma
- Keywords
- magnetic resonance imaging, positron emission tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding expired before enrollment goal could be reached.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 30 Jul 2020 (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 is designed to prospectively determine the sensitivity, specificity, and diagnostic accuracy of whole-body MRI (WBMRI) with Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for the detection of multiple myeloma.
Subjects will undergo WBMRI and fluorodeoxyglucose (FDG) positron emission tomography (PET) for research purposes either at one time point for cross-sectional study or at four time points for longitudinal study: baseline, prior to bone marrow transplant (BMT), prior to maintenance therapy, and post BMT. The results of these imaging procedures will be compared to standard of care whole body x-ray and bone marrow biopsy results.
Detailed description
Whole body magnetic resonance imaging (WBMRI) will be evaluated for detection and assessment of therapy response in multiple myeloma (MM) using a novel acquisition scheme. WBMRI with diffusion weighted imaging (DWI) has demonstrated promising preliminary results for detection and response monitoring in MM. While DWI generates high lesion-to-background contrast and excellent lesion conspicuity, it suffers from compromised image quality due to geometric distortion, particularly at 3 Tesla magnetic resonance imaging (MRI), a platform which is increasingly used in clinical practice. This disadvantage, along with high costs and patient dissatisfaction associated with long scan times, have limited wide spread adoption of WBMRI with DWI in the clinical practice.
To overcome these challenges, the investigators have developed an alternative WBMRI technique: Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for improved tumor visualization by simultaneously suppressing the confounding signals of fat and fluid throughout the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Patients | Experimental | Procedure: WBMRI, Procedure: Positron Emission Tomography/Computed Tomography (PET/CT)Patients with pathologically confirmed myeloma for cross-sectional study (detection) or scheduled to undergo induction therapy (or have gone 1-2 cycles of induction therapy), followed by either bone marrow transplantation or consolidation therapy for longitudinal study (therapy response assessment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathologically confirmed myeloma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- For cross-sectional study, no additional required treatment schedule. For longitudinal study: Patients scheduled to undergo bone marrow biopsy (BMB) and induction therapy (or have gone through 1-2 cycles of induction therapy), followed by either bone marrow transplantation (BMT) or consolidation therapy.
- Women of child-bearing potential must agree to undergo a urine pregnancy screening to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (6 listed)
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- Subjects must not be pregnant or nursing; since pregnancy is a contraindication to administration of gadolinium-based contrast agents. Furthermore, there is a potential for congenital abnormalities and the potential to harm nursing infants, associated with FDG-PET.
- Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices and other foreign bodies.
- Known severe allergic reaction to Gadolinium-based contrast agents.
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 |
|---|---|---|
| WBMRIWBMRI will be performed either at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points. 1. Baseline: (before or after 1-2 cycles of induction therapy) 2. Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) 3. Between Week 24 - 36 (before starting maintenance therapy) 4. Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy) | Procedure or surgery | Multiple Myeloma Patients |
| Positron Emission Tomography/Computed Tomography (PET/CT)PET/CT will be performed at at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points. 1. Baseline: (before or after 1-2 cycles of induction therapy) 2. Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) 3. Between Week 24 - 36 (before starting maintenance therapy) 4. Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy) | Procedure or surgery | Multiple Myeloma Patients |
Primary outcome
Detection of lesions
Time frame: Up to 4 years
Effectiveness of WBMRI DETECT for the detection of lesions in MM patients will be compared to WBMRI Diffusion Weighted Imaging (DWI). A combination of clinical MRI, whole body x-ray, FDG PET, and bone marrow biopsy will be used as the reference standard. The number of lesions identified on WBMRI-DETECT will be compared to the number of lesions identified on WBMRI-DWI. The sensitivity and specificity of WBMRI-DETECT and WBMRI-DWI will be calculated using the reference standard.
Assessment of therapy response
Time frame: Up to 4 years
Effectiveness of WBMRI for assessing therapy response will be compared to the current standard of care using FDG PET and bone marrow biopsy as the validation standard. The percentage increase in fat fraction measured using WBMRI-DETECT and the percentage increase in apparent diffusion coefficient (ADC) measured using WBMRI-DWI will be used to assess the effectiveness of WBMRI in measuring therapy response. The percentage change in SUVmax measured on PET/CT will be used as the reference standard.
Progression Free Survival (PFS)
Time frame: Up to 4 years
Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with PFS.
Overall Survival (OS)
Time frame: Up to 4 years
Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with OS.
Results and safety
The study was stopped early (reason given: Funding expired before enrollment goal could be reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
Avneesh Chhabra, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WBMRI and Positron Emission Tomography/Computed Tomography (PET/CT) in people with Multiple Myeloma, run by University of Texas Southwestern Medical Center 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 5 inclusion and 6 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 24 Jul 2025. 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 was stopped early (reason given: Funding expired before enrollment goal could be reached.). 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?
Detection of lesions (time frame: Up to 4 years). The study lists 4 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 24 Jul 2025.