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Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.

Descripción general del estudio

Descripción detallada

OBJECTIVES:

Primary

  • Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.

Secondary

  • Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
  • Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
  • Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
  • Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

  • Group 1: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
  • Group 2: Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

22

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma (MM) meeting all of the following criteria:

    • Relapsed or refractory disease
    • Previously received ≥ 2 courses of antimyeloma treatment
  • Measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g/24-hour urine collection) OR serum-free light-chain disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Creatinine ≤ 2.5 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy
  • No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk
  • No known hypersensitivity to thalidomide or lenalidomide

    • No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs
  • No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197
  • No known HIV positivity
  • No infectious hepatitis type A, B, or C

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 3 prior treatment regimens for MM
  • More than 6 months since prior lenalidomide
  • More than 28 days since prior experimental drug or therapy
  • More than 1 month since prior systemic antimyeloma therapy
  • More than 1 month since prior and no concurrent systemic corticosteroids
  • No other concurrent anticancer agents or treatments or investigational agents
  • No concurrent thalidomide
  • No concurrent radiotherapy
  • No other concurrent immune therapy or immunomodulatory agents

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group 1
Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
Administrado oralmente
Administrado por vía intramuscular
Experimental: Group 2
Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
Administrado oralmente
Administrado por vía intramuscular

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6B Antibody Response to Prevnar Vaccine in Peripheral Blood
Periodo de tiempo: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
basline and 8 weeks after second vaccination
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
Periodo de tiempo: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
basline and 8 weeks after second vaccination
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
Periodo de tiempo: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
basline and 8 weeks after second vaccination
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
Periodo de tiempo: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
basline and 8 weeks after second vaccination

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Ivan Borrello, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2007

Finalización primaria (Actual)

1 de abril de 2009

Finalización del estudio (Actual)

1 de septiembre de 2010

Fechas de registro del estudio

Enviado por primera vez

7 de marzo de 2007

Primero enviado que cumplió con los criterios de control de calidad

7 de marzo de 2007

Publicado por primera vez (Estimar)

9 de marzo de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de agosto de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2015

Última verificación

1 de agosto de 2015

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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