ID

21474

Beschreibung

Phase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00834665

Link

https://clinicaltrials.gov/show/NCT00834665

Stichworte

Versionen (1)
  1. 23.04.17 23.04.17 -
Hochgeladen am

23. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00834665

Englisch

Eligibility Multiple Myeloma NCT00834665

1 Formulare  
Criteria
Beschreibung

Criteria

1. written informed consent must be obtained from all patients before entry into the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. patients must have a diagnosis of myeloma
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
3. patients must meet one of the following criteria:
Beschreibung

Inclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy.
Beschreibung

Relapse or progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0242656
myeloma has responded partially to initial therapy but neither a complete nor a near-complete response has developed after at least 3 cycles or months of initial therapy.
Beschreibung

Response to treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0521982
myeloma has high-risk features
Beschreibung

Myeloma at high risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0026764
4. patients must have measurable disease on study entry.
Beschreibung

Measurable disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
5. patients must be between ages 18-80 (inclusive).
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. patients should have adequate vital organ function.
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
7. ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. women of child-bearing potential (wocbp) and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study and for at least 4 months after the last dose of chemotherapy. in addition, contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the steps program.
Beschreibung

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
key exclusion criteria
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
subjects who meet any of the following criteria cannot be enrolled in the study:
Beschreibung

Exclusion criteria specification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348235
1. pregnant or nursing females
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. hiv, htlv-1/2 seropositivity
Beschreibung

HIV, HTLV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0086427
3. known history of myelodysplasia
Beschreibung

Myelodysplasia

Datentyp

boolean

Alias
UMLS CUI [1]
C0026985
4. known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
Beschreibung

Chronic active hepatitis or liver cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0520463
UMLS CUI [2]
C0023890
5. active hepatitis b
Beschreibung

Active Hepatitis B

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
6. prior autotransplant or allogeneic transplant
Beschreibung

Autotransplant or allogeneic transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0040736
7. more than 4 distinct, prior courses of therapy for myeloma
Beschreibung

Myeloma therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0087111
8. history of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
Beschreibung

Severe autoimmune disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
9. active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
Beschreibung

connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0009782
UMLS CUI [2]
C0042164
UMLS CUI [3]
C0036202
UMLS CUI [4]
C0021390
UMLS CUI [5]
C0026769
10. evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
11. active bacterial, viral or fungal infections.
Beschreibung

Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00834665

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed Consent
Item
1. written informed consent must be obtained from all patients before entry into the study
boolean
C0021430 (UMLS CUI [1])
Multiple Myeloma
Item
2. patients must have a diagnosis of myeloma
boolean
C0026764 (UMLS CUI [1])
Inclusion Criteria
Item
3. patients must meet one of the following criteria:
boolean
C1512693 (UMLS CUI [1])
Relapse or progression
Item
myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy.
boolean
C0277556 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Response to treatment
Item
myeloma has responded partially to initial therapy but neither a complete nor a near-complete response has developed after at least 3 cycles or months of initial therapy.
boolean
C0521982 (UMLS CUI [1])
Myeloma at high risk
Item
myeloma has high-risk features
boolean
C0332167 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Measurable disease
Item
4. patients must have measurable disease on study entry.
boolean
C1513041 (UMLS CUI [1])
Age
Item
5. patients must be between ages 18-80 (inclusive).
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
6. patients should have adequate vital organ function.
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods
Item
8. women of child-bearing potential (wocbp) and their spouses or partners must be willing to use adequate contraception for the duration of the active treatment phase of the study and for at least 4 months after the last dose of chemotherapy. in addition, contraceptive measures must be continued as long as the patient remains on maintenance thalidomide in accordance with the steps program.
boolean
C0700589 (UMLS CUI [1])
Exclusion Criteria
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Exclusion criteria specification
Item
subjects who meet any of the following criteria cannot be enrolled in the study:
boolean
C0680251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Gynaecological status
Item
1. pregnant or nursing females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV, HTLV
Item
2. hiv, htlv-1/2 seropositivity
boolean
C0019682 (UMLS CUI [1])
C0086427 (UMLS CUI [2])
Myelodysplasia
Item
3. known history of myelodysplasia
boolean
C0026985 (UMLS CUI [1])
Chronic active hepatitis or liver cirrhosis
Item
4. known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
boolean
C0520463 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
Active Hepatitis B
Item
5. active hepatitis b
boolean
C0019163 (UMLS CUI [1])
Autotransplant or allogeneic transplant
Item
6. prior autotransplant or allogeneic transplant
boolean
C0040736 (UMLS CUI [1])
Myeloma therapy
Item
7. more than 4 distinct, prior courses of therapy for myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Severe autoimmune disease
Item
8. history of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
boolean
C0004364 (UMLS CUI [1])
connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis
Item
9. active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
boolean
C0009782 (UMLS CUI [1])
C0042164 (UMLS CUI [2])
C0036202 (UMLS CUI [3])
C0021390 (UMLS CUI [4])
C0026769 (UMLS CUI [5])
Comorbidity
Item
10. evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which might increase the risks of participating in the study
boolean
C0009488 (UMLS CUI [1])
Infection
Item
11. active bacterial, viral or fungal infections.
boolean
C0009450 (UMLS CUI [1])
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