Multiple MyelomaPhase 1NCT05892393
Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
A Phase 1 study testing Zirconium Zr 89-DFO-YS5, Positron Emission Tomography / Computed Tomography (PET/CT) and Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in people with Multiple Myeloma and Plasma Cell Myeloma, run by Robert Flavell, MD, PhD at 1 site in United States.
Trial summary
This phase I trial tests the safety of [89Zr]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. [89Zr]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Myeloma
- What is being tested?
- Zirconium Zr 89-DFO-YS5, Positron Emission Tomography / Computed Tomography (PET/CT) and Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to 1 Mar 2027
- Phase
- Phase 1
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
- Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria
- At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria
- Age >= 18 years
- Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =< 3 X ULN
- Alanine aminotransferase (ALT) =< 3 X ULN
- Creatinine clearance >= 30 mL/min, calculated using the Cockcroft-Gault equation or serum creatinine <= 1.5x the institutional upper limit of normal.
- Ability to understand a written informed consent document, and the willingness to sign it
Who cannot join
- Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen
- Individuals who are pregnant or breastfeeding/chestfeeding.
- - Breast-feeding/chest-feeding should be discontinued before administration of [89ZR]DFO-YS5.
- Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of [89ZR]-DFO-YS5.
- - If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.
- - A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state ( >= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
- Individuals who are pregnant or breastfeeding/chestfeeding are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with [89ZR]-DFO-YS5
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Maya Aslam, (415) 514-8987, Maya.Aslam@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
This phase I trial tests the safety of [89Zr]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. [89Zr]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. [89Zr]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and [89Zr]DFO-YS5 PET scans may improve detection of multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 ([89Zr]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.
SECONDARY OBJECTIVES:
- To determine the safety of [89Zr]DFO-YS5. II. To determine the average organ uptake of [89Zr]DFO-YS5. III. To descriptively report the patterns of intra-tumoral uptake of [89Zr]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
IV. To calculate the dosimetry of [89Zr]DFO-YS5 in patients with multiple myeloma.
EXPLORATORY OBJECTIVE:
- To determine the association between uptake (standardized uptake value maximum [SUVmax]) of [89Zr]DFO-YS5 with 1q amplification by fluorescence in situ hybridization (FISH) on tumor biopsies (when available; FISH may be conducted as part of routine, standard-of-care).
OUTLINE: Participants are assigned to 1 of 2 cohorts based on participant preference.
COHORT A: Participants receive [89Zr]DFO-YS5 intravenously (IV) and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.
COHORT B: Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.
Patients are followed up at 30 days after final scan.
- Conditions
- Multiple Myeloma, Plasma Cell Myeloma
- Being tested
- Zirconium Zr 89-DFO-YS5, Positron Emission Tomography / Computed Tomography (PET/CT), Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI), Fludeoxyglucose F-18
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium Zr 89-DFO-YS5Drug
Also called (89)Zr-DFO-YS5, 89Zr DFO-YS5
Given IV
Positron Emission Tomography / Computed Tomography (PET/CT)Procedure or surgery
Also called PET/CT
Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)Procedure or surgery
Also called PET/MRI
Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.
Fludeoxyglucose F-18Other
Also called Fludeoxyglucose (18F)
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort A ([89Zr]DFO-YS5, single scan | Experimental | Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1 Receives: Drug: Zirconium Zr 89-DFO-YS5; Procedure: Positron Emission Tomography / Computed Tomography (PET/CT); Procedure: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI); Other: Fludeoxyglucose F-18 |
| Cohort B ([89Zr]DFO-YS5, multiple scans | Experimental | Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1 Receives: Drug: Zirconium Zr 89-DFO-YS5; Procedure: Positron Emission Tomography / Computed Tomography (PET/CT); Procedure: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI); Other: Fludeoxyglucose F-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of metastatic lesion
Defined as the rate of lesions with positive uptake when compared against 18F-fluorodeoxyglucose (FDG) PET/computed tomography (CT) positivity. Sensitivity estimated based on lesion level without considering the location of the lesions or the possible intracorrelation of the lesions from the same patient by point estimate with its 95% confidence interval.
Measured: Up to 1 week
Median maximum standardized uptake value (SUVmax)
The median and range of standardized uptake value maximum (SUVmax) (across all metastatic lesions per participant) in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
Measured: Up to 1 week
Median Standardized Uptake Value averaged across lesions (SUVmax-avg)
The median and range of SUVmax-average across all lesions in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.
Measured: Up to 1 week
Secondary outcomes (4)
Proportion of participants reporting treatment-related Adverse Events
Will be reported descriptively using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 35 days
Average organ uptake of [89Zr]DFO-YS5
Regions of interest will be drawn on major organs, and the SUVmax calculated for each patient. Average organ uptake reported with descriptive statistics, including the mean and standard deviation (SD).
Measured: Up to 1 week
Descriptive patterns of intra-tumoral uptake of [89Zr]DFO-YS5
On whole body PET, site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal. The median and range for intra-tumoral SUVmax within metastatic lesions will be reported descriptively on a per-lesion basis to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
Measured: Up to 1 week
Dosimetry measurements (Cohort B only)
Dosimetry calculations will be performed and reported in millisievert (mSv)/megabecquerels (MBq) on a per-patient basis. Time-activity curves will be generated for each organ, and curve-fitting will be performed to derive the time-integrated activity coefficients
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start16 Jun 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Flavell, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Robert Flavell, MD, PhD, University of California, San Francisco
- Investigators
- Robert Flavell, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892393
- Sponsor's protocol ID
- 23925
- Other IDs
- NCI-2023-04068, R01CA271606
- Status last verified
- Sep 2026
- First submitted
- 26 May 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No