ID

13061

Descripción

DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT00083681

Link

https://clinicaltrials.gov/show/NCT00083681

Palabras clave

  1. 13/1/16 13/1/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

13 de enero de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Multiple Myeloma NCT00083681

Eligibility Multiple Myeloma NCT00083681

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant. high risk is defined as any one of the following at the time of relapse:a) plasma cell labeling index (pcli) > 1%, b) bone marrow plasmacytosis > or = 30%, c)bartl grade >or = 2 on bone marrow biopsy, or d)cytogenetic abnormalities of chromosome 13, 11q, or any translocation at the time of relapse.
Descripción

multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
patients must be 18 years of age or older. women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
Descripción

age, contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0700589
patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patients must have a swog performance status of 0-2. patients with a poor performance status (3-4) based solely on bone pain, will be eligible.
Descripción

performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl
Descripción

renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. pregnancy testing is not required for 1) women wh have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
Descripción

pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
patients must have adequate bone marrow function, as defined by platelet count of 150,000/microliter, unless explained by extensive marrow plasmacytosis.
Descripción

bone marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005821
patients must be off chemotherapy (excluding steroids) and local radiotherapy for > 3 weeks prior to entering the study
Descripción

chemotherapy, radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
there must be no evidence of active infection requiring iv antibiotics
Descripción

active infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
no other concurrent therapy for myeloma is permitted while on protocol
Descripción

concurrent therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111

Similar models

Eligibility Multiple Myeloma NCT00083681

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
all patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant. high risk is defined as any one of the following at the time of relapse:a) plasma cell labeling index (pcli) > 1%, b) bone marrow plasmacytosis > or = 30%, c)bartl grade >or = 2 on bone marrow biopsy, or d)cytogenetic abnormalities of chromosome 13, 11q, or any translocation at the time of relapse.
boolean
C0026764 (UMLS CUI [1])
age, contraception
Item
patients must be 18 years of age or older. women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
boolean
C0001779 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
informed consent
Item
patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
boolean
C0021430 (UMLS CUI [1])
performance status
Item
patients must have a swog performance status of 0-2. patients with a poor performance status (3-4) based solely on bone pain, will be eligible.
boolean
C1520224 (UMLS CUI [1])
renal function
Item
patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
pregnancy
Item
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. pregnancy testing is not required for 1) women wh have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
boolean
C0032961 (UMLS CUI [1])
bone marrow function
Item
patients must have adequate bone marrow function, as defined by platelet count of 150,000/microliter, unless explained by extensive marrow plasmacytosis.
boolean
C0005821 (UMLS CUI [1])
chemotherapy, radiotherapy
Item
patients must be off chemotherapy (excluding steroids) and local radiotherapy for > 3 weeks prior to entering the study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
active infection
Item
there must be no evidence of active infection requiring iv antibiotics
boolean
C0009450 (UMLS CUI [1])
concurrent therapy
Item
no other concurrent therapy for myeloma is permitted while on protocol
boolean
C0087111 (UMLS CUI [1])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial