ID

22018

Descripción

Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.; ODM derived from: https://clinicaltrials.gov/show/NCT00306735

Link

https://clinicaltrials.gov/show/NCT00306735

Palabras clave

Versiones (1)
  1. 14/5/17 14/5/17 -
Subido en

14 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00306735

Inglés

Eligibility Multiple Myeloma NCT00306735

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provide written informed consent
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. age greater than or equal to 18 years
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3. histologically confirmed multiple myeloma
Descripción

multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
4. karnofsky index greater than or equal to 50%
Descripción

karnofsky index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
5. scheduled to receive a regimen containing melphalan at a dose of 100 mg/m^2 on study days -2 and -1 followed by autologous stem cell transplant on day 0
Descripción

melphalan, autologous stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025241
UMLS CUI [2]
C1831743
6. known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
Descripción

hepatic, renal, cardiovascular impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0007222
7. women of childbearing potential must use reliable contraceptive measures and have negative pregnancy tests at screening
Descripción

effective contraception, pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032976
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability or unwillingness to understand or to cooperate with the study procedures
Descripción

compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
2. received any investigational drugs within 30 days before study entry
Descripción

investigational drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
3. received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on study day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:
Descripción

antiemetics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003297
1. 5-ht3 receptor antagonists;
Descripción

5-ht3 receptor antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936526
2. dopamine receptor antagonists (metoclopramide);
Descripción

dopamine receptor antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242702
3. phenothiazine antiemetics (prochlorperazine, thiethylperazine and perphenazine);
Descripción

phenothiazine antiemetics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031436
4. atypical antipsychotic agents with compazine-like activity (e.g. olanzapine, risperidone);
Descripción

atypical antipsychotic agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040615
5. haloperidol, droperidol, tetrahydrocannabinol, or nabilone;
Descripción

haloperidol, droperidol, tetrahydrocannabinol, nabilone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018546
UMLS CUI [2]
C0013136
UMLS CUI [3]
C0039663
UMLS CUI [4]
C0068333
6. any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), unless used as a preventative measure for chemotherapy toxicities. topical or inhaled preparations are allowed; and,
Descripción

systemic corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2825233
7. any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either cause nausea or vomiting or used to treat nausea or vomiting.
Descripción

non-prescription medication, nutrition supplements, vitamins, herbal products

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C3661837
UMLS CUI [3]
C0042890
UMLS CUI [4]
C0025125
note: with the exception of first-generation 5-ht3-receptor antagonists, above medication(s) may be used as rescue medication.
Descripción

first generation 5-ht3-receptor antagonists

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936526
4. any vomiting, retching or national cancer institute (nci) common terminology criteria for adverse events, version 3.0, grade 2-4 nausea in the 24 hours preceding chemotherapy;
Descripción

nci common terminology criteria for adverse events, vomiting, retching, nausea

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0042963
UMLS CUI [1,3]
C0232602
UMLS CUI [1,4]
C0027497
5. ongoing vomiting for any organic etiology;
Descripción

vomiting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042963
6. scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in the protocol;
Descripción

emetogenic chemotherapeutic agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0013973
7. known contraindication to 5-ht3 receptor antagonists;
Descripción

5-ht3-receptor antagonists contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2936526
UMLS CUI [1,2]
C1301624
8. received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.
Descripción

radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Multiple Myeloma NCT00306735

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
2. age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
multiple myeloma
Item
3. histologically confirmed multiple myeloma
boolean
C0026764 (UMLS CUI [1])
karnofsky index
Item
4. karnofsky index greater than or equal to 50%
boolean
C0206065 (UMLS CUI [1])
melphalan, autologous stem cell transplant
Item
5. scheduled to receive a regimen containing melphalan at a dose of 100 mg/m^2 on study days -2 and -1 followed by autologous stem cell transplant on day 0
boolean
C0025241 (UMLS CUI [1])
C1831743 (UMLS CUI [2])
hepatic, renal, cardiovascular impairment
Item
6. known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
effective contraception, pregnancy test
Item
7. women of childbearing potential must use reliable contraceptive measures and have negative pregnancy tests at screening
boolean
C0700589 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
compliance
Item
1. inability or unwillingness to understand or to cooperate with the study procedures
boolean
C1321605 (UMLS CUI [1])
investigational drugs
Item
2. received any investigational drugs within 30 days before study entry
boolean
C0013230 (UMLS CUI [1])
antiemetics
Item
3. received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on study day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:
boolean
C0003297 (UMLS CUI [1])
5-ht3 receptor antagonists
Item
1. 5-ht3 receptor antagonists;
boolean
C2936526 (UMLS CUI [1])
dopamine receptor antagonists
Item
2. dopamine receptor antagonists (metoclopramide);
boolean
C0242702 (UMLS CUI [1])
phenothiazine antiemetics
Item
3. phenothiazine antiemetics (prochlorperazine, thiethylperazine and perphenazine);
boolean
C0031436 (UMLS CUI [1])
atypical antipsychotic agents
Item
4. atypical antipsychotic agents with compazine-like activity (e.g. olanzapine, risperidone);
boolean
C0040615 (UMLS CUI [1])
haloperidol, droperidol, tetrahydrocannabinol, nabilone
Item
5. haloperidol, droperidol, tetrahydrocannabinol, or nabilone;
boolean
C0018546 (UMLS CUI [1])
C0013136 (UMLS CUI [2])
C0039663 (UMLS CUI [3])
C0068333 (UMLS CUI [4])
systemic corticosteroids
Item
6. any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), unless used as a preventative measure for chemotherapy toxicities. topical or inhaled preparations are allowed; and,
boolean
C2825233 (UMLS CUI [1])
non-prescription medication, nutrition supplements, vitamins, herbal products
Item
7. any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either cause nausea or vomiting or used to treat nausea or vomiting.
boolean
C0013231 (UMLS CUI [1])
C3661837 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
first generation 5-ht3-receptor antagonists
Item
note: with the exception of first-generation 5-ht3-receptor antagonists, above medication(s) may be used as rescue medication.
boolean
C2936526 (UMLS CUI [1])
nci common terminology criteria for adverse events, vomiting, retching, nausea
Item
4. any vomiting, retching or national cancer institute (nci) common terminology criteria for adverse events, version 3.0, grade 2-4 nausea in the 24 hours preceding chemotherapy;
boolean
C1516728 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])
C0232602 (UMLS CUI [1,3])
C0027497 (UMLS CUI [1,4])
vomiting
Item
5. ongoing vomiting for any organic etiology;
boolean
C0042963 (UMLS CUI [1])
emetogenic chemotherapeutic agents
Item
6. scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in the protocol;
boolean
C0003392 (UMLS CUI [1,1])
C0013973 (UMLS CUI [1,2])
5-ht3-receptor antagonists contraindication
Item
7. known contraindication to 5-ht3 receptor antagonists;
boolean
C2936526 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
radiotherapy
Item
8. received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.
boolean
C1522449 (UMLS CUI [1])
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