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A Study to Explore Quality of Life According to Treatment Plan for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant

Overview

Información sobre este estudio

The purpose of this study is to understand more about how multiple myeloma and its treatment affect day-to-day life for patients, with particular interest in how life is affected following stem cell transplant.

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.

Inclusion Criteria

  • Voluntarily sign an informed consent form
  • Age ≥18 years
  • Has initial diagnosis of multiple myeloma, and has had Stem Cell Transplant as treatment
    • Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma
    • Monoclonal protein present in serum and/or urine.
    • Myeloma-related organ dysfunction 1 or more
      • (C) Calcium elevation in blood
        • Serum calcium >1mg/dL (>0.25mmol/L) higher than the upper limit of normal or >11mg/dL (>2.75mmol/L)
      • (R) Renal insufficiency
        • SCr >2 mg/dL or >177 μmol/L)
      • (A) Anemia
        • Hemoglobin <10 g/dL (< 100g/L) or >2g/dL (>20g/L) below normal
      • (B) Lytic bone lesions or osteoporosis
  • Has received induction therapy followed by a single autologous stem cell transplant and should fall into one of the following subgroups
    • Immediately following transplant (within the last 30-100 days) and has not yet commenced maintenance therapy,but previously received induction therapy
      • Should not have experienced clinical progression post transplant
    • > 100 days post stem cell transplant and currently receiving lenalidomide monotherapy as maintenance therapy
      • Should not have experienced clinical progression post transplant
    • > 100 days post stem cell transplant and currently receiving treatment that is not lenalidomide monotherapy as maintenance therapy (can include lenalidomide as combination therapy)
      • Should not have experienced clinical progression post transplant
    • > 100 days post stem cell transplant and currently not receiving any maintenance therapy following induction therapy
      • Should not have experienced clinical progression post transplant
    • > 100 days post stem cell transplant and has been informed they have progressive disease
      • Should not yet have initiated the next line of treatment irrespective of whether has previously received maintenance therapy

Exclusion Criteria

  • Allogeneic transplant
  • Non-transplant
  • Pre-transplant
  • Tandem transplant
  • Further transplant (history of >1 stem cell transplant)
  • Has received consolidation therapy
  • Current involvement in a clinical trial which prohibits participation in other research

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

Rochester, Minn.

Investigador principal de Mayo Clinic

Shaji Kumar, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20271800

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