Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

Overview

Información sobre este estudio

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Study closed to enrollment

Inclusion Criteria:

  • Patient is at least 18 years old.
  • Patient has been diagnosed with symptomatic MM with measurable disease that includes at least one of the following:
    • Serum M protein ≥ 1g/dl
    • Urine M protein ≥ 200 mg/24 hrs
    • Involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • The patient is a candidate for systemic therapy that includes an IMiD® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen.
  • No more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy.
  • Patient has read, understood and signed informed consent.

Exclusion Criteria:

  • Patient is already receiving systemic therapy for MM (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study).
  • Patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
  • Patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. Patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Shaji Kumar, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Vivek Roy, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Rafael Fonseca, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20115802

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