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18F-Fluciclovine PET/CT Scan for Multiple Myeloma

Phase 2

Recruiting

Led By Elizabeth M Hill, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

ECOG performance status <= 2

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG or 18F-fluciclovine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time at each 18f-fluciclovine dose through 3 days after each dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new imaging scan is better at detecting MM than the one currently used. Participants will have 3 study visits spread over 5 yrs.

Who is the study for?

Adults over 18 with Multiple Myeloma (MM), either newly diagnosed or having relapsed after treatment, can join this trial. They must have measurable disease and be in relatively good health (ECOG <=2). Women who can bear children and men must use contraception. People with severe allergies to the study drugs, uncontrollable claustrophobia, serious illnesses that could affect participation, or breastfeeding mothers cannot participate.

What is being tested?

The trial is testing if a new imaging agent called 18F-fluciclovine is better at detecting MM than the current standard agent, 18F-FDG. Participants will undergo PET/CT scans using both agents and may also have an MRI scan and bone marrow biopsy. The tests are spread out over three visits within five years or until disease progression.

What are the potential side effects?

Possible side effects include allergic reactions to the injected substances used for imaging (18F-FDG or 18F-fluciclovine) which might cause symptoms like rash or difficulty breathing. Discomfort from lying still during scans and pain or bruising from needle insertion for biopsies may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have newly diagnosed or previously treated multiple myeloma.

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I have been diagnosed with multiple myeloma according to specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to certain imaging agents similar to 18F-FDG or 18F-fluciclovine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time at each 18f-fluciclovine dose through 3 days after each dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time at each 18f-fluciclovine dose through 3 days after each dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time at each 18f-fluciclovine dose through 3 days after each dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.

Secondary study objectives

Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.

Evaluate the ability of 18F-fluciclovine to identify minimal residual disease (MRD) as compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).

Evaluate the efficacy of 18F-fluciclovine in measuring disease volume as compared to other indicators of disease volume such as serum M protein, serum free-light chains, urine M protein, B2 microglobulin, and bone marrow plasma cell percentage.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-fluciclovine PET/CT in Multiple MyelomaExperimental Treatment2 Interventions

Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FDG PET/CT

2018

N/A

~210

0 / 5Eligibility criteria met