Copper 64Cu-DOTA-Daratumumab Positron Emission Tomography in Diagnosing Patients With Relapsed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03311828|
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Plasma Cell Myeloma Plasma Cell Myeloma Secondary Amyloidosis||Biological: Daratumumab Drug: Imaging Agent Procedure: Positron Emission Tomography Other: Pharmacological Study||Phase 1|
I. To assess safety and tolerability of unlabeled daratumumab followed by 64Cu-DOTA-daratumumab positron emission tomography, at each dose level, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.
I. Generate initial estimates of the biodistribution of the 64Cu-DOTA-daratumumab and the preferred dose of cold antibody.
II. Determine the dose of pre-administered unlabeled daratumumab that optimizes image quality of 64Cu-anti-CD38 (daratumumab)-NHS-DOTA.
III. Evaluate the sensitivity of 64Cu-anti-CD38 (daratumumab)-NHS-DOTA in detecting lesions compared to 18F fludeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) scanning.
Patients receive daratumumab intravenously (IV) over 10-45 minutes, and within 6 hours, patients receive copper 64Cu-DOTA-daratumumab IV on day 0. Patients undergo PET on days 1 and 2.
After completion of study, patients are followed up for 7 days and then at 2 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot/Feasibility Trial of 64Cu-DOTA-Daratumumab Positron Emission Tomography in Patients With Newly Diagnosed or Relapsed Multiple Myeloma|
|Actual Study Start Date :||February 21, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Diagnostic (Copper 64Cu-DOTA-daratumumab, PET)
Patients receive daratumumab IV over 10-45 minutes, and within 6 hours, patients receive copper 64Cu-DOTA-daratumumab IV on day 0. Patients undergo PET on days 1 and 2.
Drug: Imaging Agent
Given Copper 64Cu-DOTA-daratumumab IV
Other Name: Image Enhancement Agent
Procedure: Positron Emission Tomography
Other: Pharmacological Study
- Incidence of adverse event [ Time Frame: Up to 7 days ]Will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study agent(s) and reversibility or outcome.
- Detection of lesions in the body [ Time Frame: Up to 7 days ]Will be determined by copper 64Cu-DOTA-daratumumab positron emission tomography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311828
|Contact: Amrita Krishnan, MDemail@example.com|
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Amrita Krishnan, MD 626-256-4673 firstname.lastname@example.org|
|Principal Investigator: Amrita Krishnan, MD|
|Principal Investigator:||Amrita Krishnan, MD||City of Hope Medical Center|