Copper 64Cu-DOTA-Daratumumab Positron Emission Tomography in Diagnosing Patients With Relapsed Multiple Myeloma
A Pilot/Feasibility Trial of 64Cu-DOTA-Daratumumab Positron Emission Tomography in Patients With Newly Diagnosed or Relapsed Multiple Myeloma
2 other identifiers
interventional
12
1 country
1
Brief Summary
This pilot phase I clinical trial studies how well copper 64Cu-DOTA-daratumumab positron emission tomography works in diagnosing patients with multiple myeloma that has come back. Diagnostic procedures, such as copper 64Cu-DOTA-daratumumab positron emission tomography, may help evaluate the extent of multiple myeloma in patients prior to the initiation of treatment and ultimately monitor disease status/response during and post treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedStudy Start
First participant enrolled
February 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2023
CompletedMarch 12, 2024
March 1, 2024
1.9 years
October 12, 2017
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse event
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.
Up to 7 days
Secondary Outcomes (1)
Detection of lesions in the body
Up to 7 days
Study Arms (1)
Diagnostic (Copper 64Cu-DOTA-daratumumab, PET)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given Copper 64Cu-DOTA-daratumumab IV
Undergo PET
Eligibility Criteria
You may qualify if:
- All subjects must have the ability to understand and the willingness to sign a written informed consent
- Histologically confirmed multiple myeloma (newly diagnosed or relapsed)(Note: multiple myeloma patients with secondary amyloidosis are eligible)
- Ability to undergo standard PET imaging; an 18 F FDG PET/CT scan will take place within 3 months of enrollment
- Karnofsky performance status \> 70%
- Absolute neutrophil count (ANC) \>= 1000/mm\^3
- Platelet count \>= 50/mm\^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days before study enrollment
- Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
- Calculated creatinine clearance \>= 30 mL/min
- Woman of childbearing potential must be practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods; condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence (when this is in line with the preferred and usual lifestyle of the subject) during and after the study (6 months after the last dose of 64 Cu-anti-CD38 \[daratumumab\]-NHS-DOTA for women)
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
You may not qualify if:
- Daratumumab or other anti CD38 antibody treatment within 3 months prior to study enrollment
- Female patients who are lactating or have a positive pregnancy test during the screening period
- Major surgery within 14 days prior to start of study treatment
- Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment
- Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor \[GM-CSF\]); Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
- Vaccination with live attenuated vaccines within 4 weeks of study agent administration
- Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration; the following are exceptions:
- Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
- Chronic systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)
- Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis
- Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% predicted normal; Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 \< 50%
- Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure)
- Subject has history of primary immunodeficiency
- Subject is positive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B, or active hepatitis A or C
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
Related Publications (1)
Krishnan A, Adhikarla V, Poku EK, Palmer J, Chaudhry A, Biglang-Awa VE, Bowles N, Nathwani N, Rosenzweig M, Sahebi F, Karanes C, Simpson J, Sanchez JF, Yamauchi D, Parayno M, Chowdhury A, Caserta E, Marcucci G, Rockne R, Wu AM, Wong J, Forman SJ, Colcher D, Yazaki P, Shively J, Pichiorri F. Identifying CD38+ cells in patients with multiple myeloma: first-in-human imaging using copper-64-labeled daratumumab. Blood Adv. 2020 Oct 27;4(20):5194-5202. doi: 10.1182/bloodadvances.2020002603.
PMID: 33095874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amrita Krishnan, MD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 17, 2017
Study Start
February 21, 2018
Primary Completion
January 22, 2020
Study Completion
June 5, 2023
Last Updated
March 12, 2024
Record last verified: 2024-03