First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
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|ClinicalTrials.gov Identifier: NCT03665155|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: 89Zr-daratumumab Device: PET/CT scans Other: Blood draws||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase I/II study with the goal to assess the feasibility of using the anti-CD38 monoclonal antibody daratumumab, labeled with Zirconium-89 (89Zr ) through deferoxamine (DFO), known as 89Zr-DFO-daratumumab, for PET imaging of multiple myeloma.|
|Masking:||None (Open Label)|
|Official Title:||First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.
Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients). After pharmacokinetics and radiation dosimetry are determined in phase I, additional patients will be enrolled in phase II.
2 mCi of 89Zr-daratumumab will be administered on day 0.
Device: PET/CT scans
PET/CT images will be obtained on post-administration days 1, 2-4, 5-6, and/or 7-8 following administration of 89Zr-DFO-daratumumab to determine the optimal time point for imaging.
Other: Blood draws
Blood and serum samples will be weighed and counted in a scintillation well counter calibrated for 89Zr. Immediately before or after each PET/CT imaging session,
- Evaluation of tissue distribution of 89Zr-DFO-daratumumab [ Time Frame: 2 years ]Standardized uptake value (SUV) in various organs will be estimated from VOI analysis of clinical images and converted to activity-time curves. The areas under the activity-time curves will be derived by integration, converted to residence times, and used as input to the OLINDA/EXM dosimetry program to obtain absorbed dose estimates for normal tissues.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665155
|Contact: Gary Ulaner, MD, PhDfirstname.lastname@example.org|
|Contact: Ola Landgren, MD||212-639-5126|
|United States, New York|
|Memorial Slaon-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Gary Ulaner, MD, Ph.D. 212-639-3776|
|Contact: Ola Landgren, MD 212-639-5126|
|Principal Investigator: Gary Ulaner, MD, Ph.D.|
|Principal Investigator:||Gary Ulaner, MD, PhD||Memorial Sloan Kettering Cancer Center|