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Diagnostic PET Imaging for Multiple Myeloma
Phase 1
Waitlist Available
Led By Amrita Krishnan, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days
Awards & highlights
Study Summary
This trial is testing how well a new diagnostic tool works in diagnosing patients with multiple myeloma that has come back. The tool is called copper 64Cu-DOTA-daratumumab positron emission tomography.
Who is the study for?
This trial is for patients with relapsed multiple myeloma who can undergo PET imaging, have acceptable organ function and performance status, and agree to birth control measures. Excluded are those recently treated with anti-CD38 antibodies, undergoing other cancer treatments, or having certain heart conditions, infections, or severe lung disease.Check my eligibility
What is being tested?
The study tests a diagnostic procedure using copper 64Cu-DOTA-daratumumab PET scans to assess the extent of multiple myeloma in patients before and after treatment. It's a phase I trial focused on evaluating how well this new imaging technique works.See study design
What are the potential side effects?
As this is an imaging study primarily involving diagnostic procedures rather than drug interventions, side effects may include discomfort from the PET scan process itself or reactions related to the daratumumab-based tracer used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse event
Secondary outcome measures
Detection of lesions in the body
Side effects data
From 2023 Phase 2 trial • 257 Patients • NCT0133303379%
Nausea
64%
Platelet count decreased
46%
Vomiting
46%
Neutrophil count decreased
41%
Paresthesia
41%
Diarrhea
38%
Lymphocyte count decreased
28%
Dysphagia
26%
Dyspnea
23%
Fatigue
21%
White blood cell decreased
18%
Anemia
15%
Anorexia
15%
Headache
13%
Peripheral motor neuropathy
13%
Dehydration
10%
Laryngopharyngeal dysesthesia
10%
Flu like symptoms
10%
Fever
10%
Hyponatremia
10%
Myalgia
8%
Insomnia
8%
Esophageal pain
8%
Esophagitis
8%
Chills
8%
Weight loss
8%
Hyperglycemia
8%
Hypocalcemia
8%
Arthralgia
8%
Hypotension
5%
Hypoalbuminemia
5%
Sinus tachycardia
5%
Pain
5%
Bloating
5%
Constipation
5%
Hypokalemia
5%
Peripheral sensory neuropathy
5%
Aspiration
5%
Alopecia
5%
Skin and subcut tissue disord - Oth spec
5%
Febrile neutropenia
3%
Hypoxia
3%
Soft tissue infection
3%
Hypophosphatemia
3%
Depression
3%
Pharyngolaryngeal pain
3%
Dysgeusia
3%
Gastroparesis
3%
Pain in extremity
3%
Edema limbs
3%
Stomach pain
3%
Cardiac arrest
3%
Thrombotic thrombocytopenic purpura
3%
Esophageal hemorrhage
3%
Esophageal obstruction
3%
Lung infection
3%
Sepsis
3%
Tooth infection
3%
Alkaline phosphatase increased
3%
Back pain
3%
Atelectasis
3%
Cough
3%
Epistaxis
3%
Hiccups
3%
Hoarseness
3%
Pleural effusion
3%
Pleuritic pain
3%
Rash maculo-papular
3%
Hypertension
3%
Phlebitis
3%
Superficial thrombophlebitis
3%
Vascular disorders - Other, specify
3%
Thromboembolic event
3%
Blood and lymph sys disorders - Oth Spec
3%
Palpitations
3%
Sinus bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFOX Non-Responder
CP Responder
FOLFOX Responder
CP Non-Responder
CP No Cross-over
FOLFOX No Cross-over
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (Copper 64Cu-DOTA-daratumumab, PET)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2240
Imaging Agent
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
37 Trials studying Multiple Myeloma
3,447 Patients Enrolled for Multiple Myeloma
Amrita Krishnan, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received daratumumab or another treatment targeting CD38 within the last 3 months before the study.You are able to have a standard PET scan, which involves an imaging test using a special type of sugar within 3 months of joining the study.You have another type of cancer that is currently being treated, unless it's an exception.You are allergic or have bad reactions to certain types of medications made from human proteins.You have a serious heart condition or have had a heart attack in the last year.You have been diagnosed with multiple myeloma, whether it's a new diagnosis or if it has come back. If you have multiple myeloma along with another condition called secondary amyloidosis, you can still participate.You are able to perform daily activities and self-care without much difficulty.You have had a serious infection needing antibiotics in the two weeks before the study starts.You have HIV, chronic or active hepatitis B, or active hepatitis A or C.You have certain rare blood disorders like plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary amyloidosis.You are currently taking other cancer treatments like chemotherapy, biologic therapy, or hormonal therapy. You are also taking bone marrow stimulant medications.Your bilirubin levels are not higher than 1.5 times the normal limit.Your platelet count should be at least 50/mm^3, and you cannot have received a platelet transfusion within 7 days before joining the study.Your ALT and AST levels in the blood should not be more than 3 times the upper limit of normal.You have a history of a weak immune system since birth.You have chronic obstructive pulmonary disease (COPD) with very low breathing test results.You have enough infection-fighting white blood cells in your body.Your kidneys work well enough to clear creatinine at a rate of 30 milliliters per minute or more.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (Copper 64Cu-DOTA-daratumumab, PET)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in this clinical exploration?
"At this time, the study in question is not currently recruiting. It was posted on February 21st 2018 and last updated on November 22nd 2022. Those looking for additional trials may consider neoplasms or positron emission tomography studies as there are 906 and 140 such clinical trials actively seeking participants respectively."
Answered by AI
Has the FDA sanctioned Positron Emission Tomography for medical use?
"Due to its experimental nature, the risk associated with PET is judged at a conservative level 1. This judgement reflects the lack of data present regarding both safety and efficacy in Phase 1 trials."
Answered by AI
Are any other experiments utilizing Positron Emission Tomography currently being conducted?
"Currently, 140 Positron Emission Tomography studies are in operation. Of these, 26 have progressed to Phase 3. These trials are primarily based around Harrison, New york yet span over 5,564 locations globally."
Answered by AI
What conditions is Positron Emission Tomography regularly used to diagnose?
"Positron Emission Tomography is the preferred method for treating biological response modifiers, but it has been observed to improve conditions such as refractory multiple myeloma, relapsed or refractory multiple myeloma and cell transplants."
Answered by AI
Is this experiment currently enrolling participants?
"Per the details available on clinicaltrials.gov, this specific medical research is not recruiting any further patients at present. Initially posted in February 2018 and last edited in November 2022, while it has now concluded its recruitment phase; 1046 other studies are actively searching for participants presently."
Answered by AI
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