Multiple MyelomaEarly Phase 1NCT06636175
64Cu-LLP2A for Imaging Hematologic Malignancies
A Early Phase 1 study testing 64Cu-LLP2A and PET/CT in people with Multiple Myeloma and Low-Grade Lymphoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Low-Grade Lymphoma, Follicular Lymphoma
- What is being tested?
- 64Cu-LLP2A and PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2025to 28 Aug 2026
- Phase
- Early 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years of age or older
- Able to give informed consent.
- Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
- Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
- No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.
- No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.
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- Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.
- Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:
- Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
- Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia
- Adult 18 years of age or older and able to provide informed consent
- Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
- No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative
- Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.
- Conditions
- Multiple Myeloma, Low-Grade Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma, Small Lymphocytic Lymphoma
- Being tested
- 64Cu-LLP2A, PET/CT
- Keywords
- PET, Imaging
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-LLP2ADrug
64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
PET/CTDevice
The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating oncologist/surgeon unless, in the judgment of the principal investigator, the images demonstrate an unsuspected abnormality that may warrant further evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A | Experimental | - Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs:
* Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan
* Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan
* ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection) Receives: Drug: 64Cu-LLP2A; Device: PET/CT |
| Cohort 2B: Quantitative 64Cu-LLP2A | Experimental | - Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B. Receives: Drug: 64Cu-LLP2A; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ dosimetry of participants
Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of 64Cu-LLP2A (all of Cohort 1 + up to 10 cohort 2 subjects). Average organ activity concentration will be measured, and decay corrected by utilizing regions of interest (ROIs) drawn around all organ visible on 64Cu-LLP2A images. Activity organ residence times will be calculated by numerical or analytical integration of the time-activity curves. Uptake/clearance functional fits of mono- or bi-exponential functions will be performed and analytical integration, accounted for physical decay, will be performed. The calculated residence times will be used with the program OLINDA/EXM for 64Cu and using the adult human (female and male) model to calculate the individual organ radiation dose, the whole-body dose and the effective dose.
Measured: Through completion of PET/CT scans (estimated to be up to 2 days)
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
Follow-up telephone call or in person visit to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging. Additional chart review can be performed as needed.
Measured: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)
Secondary outcomes (3)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images
Overall, PET image quality will be graded visually (using 4-point scale with 1 being the worst and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies)
Measured: Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake
As measured by placing ROI and calculating SUVmax where SUVmax is a mathematical measurement of tumor burden seen on images and calculated by the following equation SUVmax= r / (a'/w) where r= radioactivity concentration in tumor (kBq/ml) as measured by the PET scanner within a defined region of interest, a'=the decay corrected amount of injected 64Cu-LLP2A and w= weight of the patient in grams
Measured: Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio
As measured by placing ROI and calculating SUVmax
Measured: Through completion of PET/CT scans (estimated to be up to 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start20 Mar 2025
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Why it stopped: Loss of further funding
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 Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For Cohort 1B, 6 healthy volunteers and 6 patients with either multiple myeloma (MM) or lymphoma will be recruited (healthy volunteers will be split equally with 3 men and 3 women enrolled, all efforts will be made to keep the number of subjects with MM and lymphoma enrolled equal to Cohort 1B but it will not be a requirement).
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Farrokh Dehdashti, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636175
- Sponsor's protocol ID
- 202505198
- Other IDs
- R42CA257797
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No