Informações:
Falhas:
ID
13061
Descrição
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
Palavras-chave
Versões (1)
- 13/01/2016 13/01/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
13 de janeiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00083681
Eligibility Multiple Myeloma NCT00083681
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT00083681
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
C1522449 (UMLS CUI [2])
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])