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A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Minocycline

+ Questionnaires

+ Placebo

MedicamentoConductualOtro
Quiénes están siendo reclutados

Trastornos de las Proteínas Sanguíneas+10

+ Enfermedades Cardiovasculares

+ Enfermedades Hematológicas

A partir de 18 años
+13 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 2
Intervencional
Inicio del estudio: marzo de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 24 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 22 de marzo de 2013

Fecha en la que se inscribió al primer participante.

Study Groups: If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take a placebo during maintenance therapy. Group 2 will take minocycline during maintenance therapy. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. Neither participant nor the study staff will know if participant is receiving the study drug or the placebo. However, if needed for participant's safety, the study staff will be able to find out what they are receiving. Study Drug Administration: Participant will take the study drug/placebo by mouth, two times a day for about 3 months, starting the first day (or within 2 days) that they begin their lenalidomide therapy. Participant should take the study drug/placebo with a full glass (8 ounces) of water. Participant may take it with or without food, but if the study drug/placebo causes an upset stomach, participant should take it with food. Study Visits: Participant must bring the study drug/placebo container, along with any remaining drug, with them to their clinic visit at each new cycle of lenalidomide therapy, or at the clinic visit when the study is over if no clinic visits are scheduled until then. Before participant starts lenalidomide therapy: Participant will fill out 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires. A study staff member will ask participant questions about their demographic information, such as their marital status, job status, education, and race. Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick. Biomarkers are found in the blood/tissue and may be related to participant's reaction to the study drug. Researchers want to study how changes in the biomarkers may be related to the symptoms reported by participants in this study. During lenalidomide therapy: °Participant will complete a symptom questionnaire in the clinic or by telephone 1 time each week about any symptoms they may be having and how they may be affecting participant's daily activities. The symptom questionnaire should take about 3-5 minutes to complete each time. During participant's clinic visit at each new cycle of lenalidomide therapy: Participant will fill out 3 questionnaires about their pain and other symptoms. It should take about 15-20 minutes to complete all of the questionnaires each time. If no clinic visit is scheduled until the study is over, these questionnaires will be collected over the phone by the study coordinator. Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick. End-of-Treatment Visit: Participant will have an end-of-treatment visit at the end of month 3. At this visit, participant will complete 4 questionnaires about pain and other symptoms. It should take about 20-25 minutes to complete all of the questionnaires. Blood (about 2 tablespoons) will be drawn for biomarker testing. This will be during an already scheduled blood draw and participant would not need to have an extra needle stick. Length of Study: Participant may continue taking the study drug/placebo for up to 3 months. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if they are unable to follow study directions, or the study doctor thinks it is in their best interest. This is an investigational study. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. The use of minocycline to reduce chemotherapy related side effects in patients with MM is currently being used for research purposes only. Up to 88 participants will take part in this study. All will be enrolled at MD Anderson Cancer Center.

NCT01793051
Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 24 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 88 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos de las Proteínas SanguíneasEnfermedades CardiovascularesEnfermedades HematológicasEnfermedades hemáticas y linfáticasTrastornos HemorrágicosEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoParaproteinemiasEnfermedades VascularesMieloma Múltiple

Criterios

6 criterios de inclusión requeridos para participar
Patients > or = 18 years old

Patients able to render informed consent and to follow protocol requirements

Patients who speak English (due to patient-reported outcome language options, we are only accruing English-speaking patients to the protocol)

Patients with normal hepatic function according to MD Anderson testing standards and no prior liver disease [screening results for total bilirubin must be < 1.5 times the upper limit of normal; screening results for alkaline phosphatase (ALP) and alanine aminotransferase (ALT) must be < 2 times the upper limit of normal; if available, screening results for aspartate aminotransferase (AST) must be < 2 times the upper limit of normal]

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7 criterios de exclusión impiden participar
Patients on Vitamin K antagonist warfarin

Patients taking any tetracycline in the last 15 days

Patients who are enrolled in other clinical trials that have symptom management as primary outcome

Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Minocycline 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance chemotherapy for MM. Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Grupo II

Placebo
Placebo 200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy). Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

University of Texas MD Anderson Cancer Center

Houston, United StatesAbrir University of Texas MD Anderson Cancer Center en Google Maps
Completado1 Centros de Estudio