A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma
Minocycline
+ Questionnaires
+ Placebo
Trastornos de las Proteínas Sanguíneas+10
+ Enfermedades Cardiovasculares
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 88 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
PlaceboObjetivos 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