Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06103838

Reclutamiento

18F-Fluciclovine PET/CT in Multiple Myeloma

Intervencionista

Fase 2

National Institutes of Health Clinical Center

Background:

Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.

Objective:

To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.

Eligibility:

Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).

Design:

Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body.

All participants will have 3 study visits. During each visit they will have:

Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine.

An optional magnetic resonance imaging scan.

A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.

These tests may be spread over 30 days for each visit.

NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.

All participants will have a third study visit after 5 years or when their disease progresses....

Mostrar descripción detallada

Categoría de tratamiento

Radiofármacos, Procedimiento

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2024-03-25

Última actualización por el patrocinador

2025-12-02

Finalización estimada

2026-12-06

Elegibilidad

Criterios de inclusión

* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein >= 3 g/dL and/or bone marrow plasma cells >= 10% and at least one of the following:

* Anemia: Hemoglobin <=10 g/dL, or

* Renal Failure: serum creatinine >= 2.0 mg/dL, or

* Hypercalcemia: Ca >= 10.5 mg/dL, or

* Lytic bone lesions on X-ray, CT, or PET/CT, or

* >= 2 focal lesions on spinal MRI, or

* >= 60% bone marrow plasma cells, or

* Involved/un-involved serum free light chain ration >= 100

* Participants must have measurable disease defined by any one of the following:

* Monoclonal bone marrow plasma cells > 5%

* Serum monoclonal protein >= 0.2 g/dl

* Urine monoclonal protein > 200 mg/24 hr

* Serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio

* A measurable lesion on PET/CT or MRI

* Participants fit criteria for one of the following categories:

* Newly diagnosed multiple myeloma (NDMM)

* Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy

* Age >=18 years.

* ECOG performance status <= 2

* Negative serum or urine pregnancy test at screening for WOCBP.

* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.

* Ability of subject to understand and the willingness to sign a written informed consent document.

Criterios de exclusión

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

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.

* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.

* Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.

* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.

¿Cree usted que este ensayo clínico se muestra por error?

Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir60

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: 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).

Intervenciones:

18F-fluciclovine injection
18F-FDG PET/CT

Medidas de resultado

Medidas de resultado primarias

To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.After 50 evaluable participants have completed baseline scans.

The performance of 18F-fluciclovine PET/CT is assessed by concordance with the 18F-FDG PET/CT imaging in scan positivity. A positive lesion is defined as focal uptake greater than background associated with abnormal CT findings (i.e., lytic bone lesions or extramedullary tissue.) The point estimates and 95% confidence intervals of the concordance rate in scan positivity between 18F-fluciclovine and 18F-FDG PET/CT will be reported.

Medidas de resultado secundarias

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.Between Timepoint #1 and Timepoint #3

Disease volumes measured by 18F-fluciclovine will be correlated with 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 by Spearman rank correlation.

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).Between Timepoint #1 and Timepoint #3

Status of minimal residual disease (MRD) identified by 18F-fluciclovine will be compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).

Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.Between Timepoint #1 and Timepoint #3

Response after treatment determined by 18F-fluciclovine will be compared to the IMWG response criteria by McNemar test.

Evaluate the safety of 18F-fluciclovine as a radiotracer in patients with multiple myeloma.From the time at each 18F-fluciclovine dose through 3 days after each dose.

All participants will be evaluable for toxicity from the time at each 18F-fluciclovine dose through 3 days after each dose. Safety of the agents will be assessed by determining the type, grade, and frequency of adverse events noted in each participant who receives at least one dose of each of the study treatments. Safety data will be presented in a summary.

¿Interesado en participar?

Obtenga más información sobre este ensayo y si puede ser elegible para participar.

Guardar ensayo

Compartir ensayo por correo electrónico

Descargar ensayo

¿Cree usted que este ensayo clínico se muestra por error?

Reportar ensayo

Descargar ensayo

Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

National Institutes of Health Clinical Center
Bethesda, Maryland, US

Reclutando

Bethesda, Maryland, 20892 US

National Institutes of Health Clinical Center

Loading Maps...