89Zr-daratumumab PET/CT for Multiple Myeloma

Phase-Based Estimates
Hoag Memorial Hospital Presbyterian, Irvine, CA
Multiple Myeloma+1 More
89Zr-daratumumab PET/CT - Drug
All Sexes
Eligible conditions
Multiple Myeloma

Study Summary

This study is evaluating whether a new imaging agent may help detect myeloma in patients.

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Eligible Conditions

  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 89Zr-daratumumab PET/CT will improve 3 primary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of up to 3 years.

up to 3 years
89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging
89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging
Prediction of response to therapy

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

CD38-positive multiple myeloma

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. 89Zr-daratumumab PET/CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

CD38-positive multiple myeloma
Patients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Who is running the study

Principal Investigator
G. U.
Gary Ulaner, Director Molecular Imaging and Therapy
Hoag Memorial Hospital Presbyterian

Closest Location

Hoag Memorial Hospital Presbyterian - Irvine, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female ≥ 21 years of age
Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
ECOG performance status 0 to 2
Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of multiple myeloma?

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The signs and symptoms of multiple myeloma include osteomalacia, hypercalcaemia, reduced creatinine, and weight loss. There may also be blood abnormalities, e.g. low platelets, anaemia, increased blood urea, increased creatinine, or raised triglycerides. These signs imply an underlying neoplastic process.

Unverified Answer

What causes multiple myeloma?

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[A large number of cells proliferate in the marrow of your bone marrow, which grow unchecked and release abnormal cells and proteins into your bloodstream, damaging the body's bone marrow and blood cells, as well as disrupting the cells' ability to produce the proteins and immune system cells needed to fight off disease and repair damage caused by cells that are stressed from the disease and to keep it from happening again. Multiple myeloma gets here by a very different and complex pathway than that of other cancers, which typically begin in your skin and begin a growth cycle in your blood and then move to the bone. Myeloma is not yet fully understood. Please see links at left.

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How many people get multiple myeloma a year in the United States?

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The number of people with multiple myeloma is increasing, whereas the number of new cases of multiple myeloma per year appears to be leveling off. This contrasts with other countries in which multiple myeloma prevalence has been increasing faster than is seen in the United States in the past decade. This may reflect changes in the natural history of people with multiple myeloma, including improved detection and treatment, or an actual decline in the prevalence of multiple myeloma in this country.

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What are common treatments for multiple myeloma?

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Treatment for multiple myeloma is complex. Current treatment options may include chemotherapy, biological therapies, radiation therapy, auto- and allogenic bone-marrow transplants, and more. However, relapse and disease progression occur frequently and current trends to personalized treatment are dependent on results from ongoing clinical trials.

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What is multiple myeloma?

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Data from a recent study has shown that the most common and prevalent form of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) is IgG4-related myeloma. The current study also provided insights into myeloma biology by defining the most up-to-date molecular events in the disease, as well as an evidence-based approach for treating these diseases.

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Can multiple myeloma be cured?

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While new treatment options are being developed with great efficacy to reduce many symptoms and reduce the number of patients needing supportive care with their current therapy, some patients do not respond. It may be reasonable, however, to continue with existing therapeutic options and offer patients the possibility that they have a longer life expectancy with the hope of improved treatment, particularly if the current regimens do not work for the patient. Further work on personalized treatment may be needed in some cases.

Unverified Answer

What does 89zr-daratumumab pet/ct usually treat?

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• Overall, [89zr-d/ct] can be an effective treatment for patients with MM who become symptomatic or whose disease progresses on treatment with bortezomib, ixabepilone, ambitoxin, or dexamethasone in the first line or in refractory settings. It can also provide durable stabilization and even improvement in patients who are stable on [89zr-d/ct] at time of initiation of maintenance therapy with newer agents like lenalidomide. • A combination of therapies including [89zr-d/ct] is preferred for patients with active MM with refractory disease.

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How serious can multiple myeloma be?

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It is difficult to give a precise estimate from the statistics about how the disease will progress and the likelihood of dying from myeloma, but the outlook is generally bad: median and mean survival may continue to decline and be at a very low percentage even after treatment. Survival curves show that myeloma is one of the leading causes of cancer-related death or illness in the United States, and there is good reason to assume that the numbers will continue to rise.

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What are the common side effects of 89zr-daratumumab pet/ct?

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Among all studied patients, most common side effects (≥ 2%) were fatigue (41%), infusion-related reactions (8%), infusion-related reactions (7%), anemia (5%) and nausea (4%). Most common (≥ 3%) grade 3/4 adverse events were neutropenia (8%), increased ALT (5%), increased AST and/or grade 2/3/4 rash (5%), and hypocalcemia (5%).

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Is 89zr-daratumumab pet/ct safe for people?

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[89zr-(D-DTPA)pet/ct] has an acceptable safety profile and is a potent B-cell radioimmunotherapeutic. Clinically, the therapeutic antibody and the radiotracer can interact synergistically to efficiently eliminate myeloma cells in humans. Because the clearance rates of the antibody vary widely between people, there is some justification for using a combination of the treatment in people with different levels of disease burden.

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Is 89zr-daratumumab pet/ct typically used in combination with any other treatments?

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The combination of 89zr-daratumumab Pet/ct and standard chemotherapy may be a viable option for the treatment of myeloma patients ineligible for allogeneic hematopoietic stem cell transplantation, particularly those patients who require the addition of other agents because of comorbidities or patient intolerance.

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How does 89zr-daratumumab pet/ct work?

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(89)Zr-Dar-Pd-DTPA-pentetreotide is absorbed faster than the conventional (89)Zr-cerium-EDTA-pentetreotide and accumulated in cell membranes similar to (99)Tc-pentetreotide. This uptake might be responsible for the high imaging quality of (89)Zr-dar-DTPA-pentetreotide, thus enabling visualization of tumors with (89)Zr-dar-DTPA-pentetreotide PET/CT.

Unverified Answer
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