Multiple MyelomaPhase 2NCT04814615
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma
A Phase 2 study testing 89Zr-daratumumab PET/CT in people with Multiple Myeloma, run by Hoag Memorial Hospital Presbyterian at 2 sites in United States.
Trial summary
Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- 89Zr-daratumumab PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2021to 15 Mar 2026
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 21 years of age
- Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
- At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
- ECOG performance status 0 to 2
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Life expectancy < 12 months
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
- History of anaphylactic reaction to humanized or human antibodies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Hoag Memorial Hospital Presbyterian
Irvine, California, 92614
Beth Thomsen, clinicaltrials@hoag.org
- Recruiting
University of Miami
Miami, Florida, 33136
Michelle D. Armogan, 305-243-7479, mda182@med.miami.edu
C. Ola Landgren, MD, PhD.
About this study
Official title: A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of 89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.
Read the detailed description
This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy.
The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.
- Conditions
- Multiple Myeloma
- Being tested
- 89Zr-daratumumab PET/CT
- Keywords
- Multiple Myeloma, 89Zr-daratumumab, Dartumumab, PET/CT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-daratumumab PET/CTDrug
Also called CD38-targeted imaging
CD38-targeting imaging
| Study group | Role | What they receive |
|---|---|---|
| CD38-positive multiple myeloma | Experimental | Patients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy. Receives: Drug: 89Zr-daratumumab PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging
89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma prior to therapy
Measured: up to 3 years
89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging
89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma following therapy
Measured: up to 3 years
Prediction of response to therapy
Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start8 Mar 2021
- Primary completion31 Jan 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
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.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Individual dose of 89Zr-DFO-daratumumab will be requested from Memorial Sloan Kettering Cancer Center and received at the Hoag Family Cancer Institute radiopharmacy for each individual 89Zr-DFO-daratumumab administration.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Ulaner, Hoag Memorial Hospital Presbyterian
- Investigators
- Leila Andreas, MS, Study director, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814615
- Sponsor's protocol ID
- 177-20-CA
- Status last verified
- Jun 2023
- First submitted
- 22 Mar 2021
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
- ClinicalTrials.gov ID
- NCT04814615
- Acronym / sponsor ID
- 177-20-CA
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, 89Zr-daratumumab, Dartumumab, PET/CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 24 Mar 2021 (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.
Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of 89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.
Detailed description
This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy.
The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individual dose of 89Zr-DFO-daratumumab will be requested from Memorial Sloan Kettering Cancer Center and received at the Hoag Family Cancer Institute radiopharmacy for each individual 89Zr-DFO-daratumumab administration.
| Arm | Type | Receives |
|---|---|---|
| CD38-positive multiple myeloma | Experimental | Drug: 89Zr-daratumumab PET/CTPatients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥ 21 years of age
- Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
- At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
- ECOG performance status 0 to 2
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (4 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Life expectancy < 12 months
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
- History of anaphylactic reaction to humanized or human antibodies.
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 |
|---|---|---|
| 89Zr-daratumumab PET/CTAlso: CD38-targeted imagingCD38-targeting imaging | Drug | CD38-positive multiple myeloma |
Primary outcome
89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging
Time frame: up to 3 years
89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma prior to therapy
89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging
Time frame: up to 3 years
89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma following therapy
Prediction of response to therapy
Time frame: up to 3 years
Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
Leila Andreas, MS study director
Hoag Memorial Hospital Presbyterian
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-daratumumab PET/CT in people with Multiple Myeloma, run by Hoag Memorial Hospital Presbyterian at 2 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary Ulaner, MD, PhD (949-557-0252, gary.ulaner@hoag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging (time frame: up to 3 years). The study lists 3 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 27 Jun 2023.