ID

22018

Beschrijving

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

Trefwoorden

Versies (1)
  1. 14-05-17 14-05-17 -
Geüploaded op

14 mei 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00306735

Engels

Eligibility Multiple Myeloma NCT00306735

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provide written informed consent
Beschrijving

informed consent

Datatype

boolean

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

age

Datatype

boolean

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

multiple myeloma

Datatype

boolean

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

karnofsky index

Datatype

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
Beschrijving

melphalan, autologous stem cell transplant

Datatype

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
Beschrijving

hepatic, renal, cardiovascular impairment

Datatype

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
Beschrijving

effective contraception, pregnancy test

Datatype

boolean

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

Exclusion Criteria

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

compliance

Datatype

boolean

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

investigational drugs

Datatype

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:
Beschrijving

antiemetics

Datatype

boolean

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

5-ht3 receptor antagonists

Datatype

boolean

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

dopamine receptor antagonists

Datatype

boolean

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

phenothiazine antiemetics

Datatype

boolean

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

atypical antipsychotic agents

Datatype

boolean

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

haloperidol, droperidol, tetrahydrocannabinol, nabilone

Datatype

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,
Beschrijving

systemic corticosteroids

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

first generation 5-ht3-receptor antagonists

Datatype

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;
Beschrijving

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

Datatype

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;
Beschrijving

vomiting

Datatype

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;
Beschrijving

emetogenic chemotherapeutic agents

Datatype

boolean

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

5-ht3-receptor antagonists contraindication

Datatype

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.
Beschrijving

radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Multiple Myeloma NCT00306735

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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