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1 Dear Healthcare Provider, Included in this PDF are recruitment brochures in several languages to be used in MM Bone study (Protocol No.: ). Kindly note these brochures have been updated according to Protocol Amendment 2 dated 11 Feb Please click on the appropriate language listed below to navigate to the EC or IRB approved brochure for your country. If your country/language does not appear below, the brochure has not yet been IRB or EC approved. Thank you. Australia-English Canada-English Ireland-English New Zealand-English Taiwan-English United Kingdom-English US English US Spanish
2 US_482_BRO Bone lesions from multiple myeloma may cause you pain or lead to skeletal complications such as: bone fractures pinching (compression) of the spinal cord radiation to bone surgery to bone Please add site contact details here MM Bone Study is a clinical research study of a study drug for adults with documented evidence of multiple myeloma. ClinicalTrials.gov Identifier: NCT Clinicaltrialsregister.eu Identifier: Amgen Protocol Number: Amendment 2 11-Feb-2013
3 What is a clinical research study? A clinical research study (also called a clinical trial) is a study in human participants to answer specific health-related questions. Some research studies determine whether investigational treatments or new ways of using current treatments are safe and effective. What can I gain from joining a clinical research study? Participants in clinical research play an integral role in developing potentially better ways to treat various medical conditions. What side effects or benefits might I experience if I take part in the study? Additionally, throughout your participation you will receive study-related medical care and monitoring. If you were recently told you have multiple myeloma, ask your doctor if the MM Bone Study is right for you. The goal of MM Bone Study is to find out if the study drug may help prevent skeletal complications in people with documented evidence of multiple myeloma. What questions should I ask if I am thinking about participating? If you are interested in participating, you should inform the study doctor and his/ her staff of your interest. The study doctor and his/her staff will provide you with the Informed Consent document, which will provide you with more information regarding the study. Please take your time to review it carefully, making note of any items that are not completely clear to you. For example: What is meant by the statement the study drug is investigational? What are the chances I will receive the study drug? What treatments are available for my condition? How long will the study take? What types of tests or procedures will be involved with the study?
4 USES_482_BRO Las lesiones óseas del mieloma múltiple pueden causar dolor o provocar complicaciones óseas tales como: fracturas óseas; compresión de la médula espinal; radiación al hueso; cirugía ósea. marcador para la información de contacto del centro El estudio óseo en el MM es un estudio de investigación clínica de un fármaco en estudio para adultos con evidencia comprobada de mieloma múltiple. Identificador en ClinicalTrials.gov: NCT Identificador en Clinicaltrialsregister.eu: Número de protocolo de Amgen: Enmienda 2 del protocolo 11-Feb-2013
5 El objetivo del Estudio óseo en el MM es averiguar si el fármaco en estudio puede ayudar a prevenir complicaciones óseas en personas con evidencia comprobada de mieloma múltiple. Qué es un estudio de investigación clínica? Un estudio de investigación clínica (también llamado ensayo clínico) es un estudio en participantes humanos para responder preguntas específicas relacionadas con la salud. Algunos estudios de investigación clínica determinan si los tratamientos en investigación o las nuevas formas de usar tratamientos ya existentes son seguros y eficaces. Qué puedo conseguir si participo en un estudio de investigación clínica? Los participantes en una investigación clínica desempeñan un papel esencial en el desarrollo de formas posiblemente mejores de tratar diversas enfermedades. Asimismo, a lo largo de su participación, recibirá atención médica y seguimiento según lo indicado en el estudio. Qué preguntas debería formular si estoy pensando en participar? Si está interesado en participar, deberá informar al médico del estudio y a su personal acerca de su interés. El médico del estudio y su personal le entregarán el documento de consentimiento informado, que le proporcionará más información sobre el estudio. Tómese su tiempo para revisarlo detenidamente, anotando aquellos aspectos que no tenga completamente claros. Por ejemplo: Qué quiere decir la frase «el fármaco en estudio estudio es experimental»? Cuáles son las probabilidades de que reciba el fármaco en estudio? Qué tratamientos están disponibles para mi enfermedad? Cuánto durará el estudio? Qué tipos de pruebas o procedimientos habrá en el estudio? Qué efectos secundarios podría experimentar o qué beneficios podría conseguir si participo en el estudio? Si le han diagnosticado mieloma múltiple hace poco, pregunte a su médico si el Estudio óseo en el MM es adecuado para usted.
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ICX Process. # People In Charge: 3 Members Experience Time: 6 Months max
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