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An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma - CA209-039

Actualizada: 08 May, 2018   |   ClinicalTrials.gov

Imprima esta página y la guía de ensayo para ayudarlo a hablar con su médico.
Use la guía de ensayo para navegar el proceso de participación en un ensayo clínico. Comprenda los factores clave que debe tener en cuenta antes de tomar una decisión y haga preguntas a su equipo de atención médica.

Detalles del ensayo

  • Phase 1/Phase 2


  • Género(s)

  • 18+

    Rango de edad

  • Recruiting

Opciones de tratamiento

Brazos del estudio
Experimental: Daratumumab vs. Nivolumab + Daratumumab
Biological: Daratumumab Biological: Nivolumab
Experimental: Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Drug: Dexamethasone Drug: Pomalidomide Biological: Daratumumab Biological: Nivolumab
Experimental: Nivolumab + Ipilimumab
Biological: Ipilimumab Biological: Nivolumab
Experimental: Nivolumab + Lirilumab
Biological: Daratumumab Biological: Lirilumab Biological: Nivolumab
Experimental: Nivolumab monotherapy (Dose Escalation)
Biological: Nivolumab

Criterios clave de elegibilidad

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD - More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant) - Have detectable disease measured by a specific protein in your blood and/or urine - Must consent to bone marrow aspirate or biopsy. Exclusion Criteria: - Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia - Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation - Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C - History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma Other protocol defined inclusion/exclusion criteria could apply

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