ID

44797

Descripción

Study of Oral IXAZOMIB in Combination With Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01335685

Link

https://clinicaltrials.gov/show/NCT01335685

Palabras clave

Versiones (1)
  1. 30/11/21 30/11/21 - Tabea Kampen
Titular de derechos de autor

Millennium Pharmaceuticals, Inc.

Subido en

30 de noviembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01335685

Alemán Inglés

Eligibility Multiple Myeloma NCT01335685

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI [1]
C1512693
male or female patient for whom standard melphalan prednisone (mp) treatment is indicated and who is not a candidate for high-dose therapy plus stem cell transplantation (hdt-sct) for 1 of the following reasons: the patient is 65 years of age or older or the patient is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of hdt-sct
Descripción

Candidate for melphalan prednisone treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0025241
UMLS CUI [1,3]
C0032952
UMLS CUI [2,1]
C0444956
UMLS CUI [2,2]
C0010858
UMLS CUI [2,3]
C1831743
UMLS CUI [2,4]
C1272460
UMLS CUI [2,5]
C0001779
UMLS CUI [2,6]
C0009488
symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
Descripción

Diagnosis of multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
measurable disease as specified in study protocol
Descripción

Measureable myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status of 0 to 2
Descripción

ECOG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
must have adequate hematologic, liver, and renal function
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0232741
female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
Descripción

No pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0036899
UMLS CUI [3,3]
C0009253
male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
Descripción

Contraception - male patients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2]
C0036899
voluntary written consent
Descripción

Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI [1]
C0680251
peripheral neuropathy that is greater or equal to grade 2
Descripción

Peripheral neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
female patients who are lactating or pregnant
Descripción

Pregnancy and breastfeeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
major surgery or radiotherapy within 14 days before the first dose of study drug
Descripción

Pretreatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0521116
uncontrolled infection requiring systematic antibiotics
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
diarrhea (> grade 1)
Descripción

Diarrhea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011991
prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
Descripción

Prior systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0026764
UMLS CUI [1,3]
C1514463
UMLS CUI [2]
C0013230
central nervous system involvement
Descripción

CNS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4050309
cardiac status as described in protocol
Descripción

Cardiac status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1999091
known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption or tolerance of ixazomib - diagnosis of smoldering multiple myeloma, waldenstrom's macroglobulinemia, poems syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
Descripción

Absorption and tolerance of ixazomib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0524722
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0392678
UMLS CUI [1,5]
C0237442
UMLS CUI [1,6]
C0175795
UMLS CUI [1,7]
C3273711
known human immunodeficiency virus (hiv) positive, hepatitis b surface antigen-positive status, or known or suspected active hepatitis c infection
Descripción

Infection and immunodeficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0009450
UMLS CUI [3,3]
C0205177
diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
Descripción

Other malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0543478
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007099
UMLS CUI [4,3]
C1522326
serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Descripción

Comorbidities

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0004936
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Similar models

Eligibility Multiple Myeloma NCT01335685

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI [1])
Candidate for melphalan prednisone treatment
Item
male or female patient for whom standard melphalan prednisone (mp) treatment is indicated and who is not a candidate for high-dose therapy plus stem cell transplantation (hdt-sct) for 1 of the following reasons: the patient is 65 years of age or older or the patient is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of hdt-sct
boolean
C3146298 (UMLS CUI [1,1])
C0025241 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0444956 (UMLS CUI [2,1])
C0010858 (UMLS CUI [2,2])
C1831743 (UMLS CUI [2,3])
C1272460 (UMLS CUI [2,4])
C0001779 (UMLS CUI [2,5])
C0009488 (UMLS CUI [2,6])
Diagnosis of multiple myeloma
Item
symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
boolean
C0026764 (UMLS CUI [1])
Measureable myeloma
Item
measurable disease as specified in study protocol
boolean
C1513041 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
must have adequate hematologic, liver, and renal function
boolean
C0221130 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
No pregnancy
Item
female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0009253 (UMLS CUI [3,3])
Contraception - male patients
Item
male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
boolean
C0004764 (UMLS CUI [1])
C0036899 (UMLS CUI [2])
Consent
Item
voluntary written consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1])
Peripheral neuropathy
Item
peripheral neuropathy that is greater or equal to grade 2
boolean
C0031117 (UMLS CUI [1])
Pregnancy and breastfeeding
Item
female patients who are lactating or pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Pretreatment
Item
major surgery or radiotherapy within 14 days before the first dose of study drug
boolean
C0679637 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Infection
Item
uncontrolled infection requiring systematic antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Diarrhea
Item
diarrhea (> grade 1)
boolean
C0011991 (UMLS CUI [1])
Prior systemic therapy
Item
prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
boolean
C1515119 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
CNS
Item
central nervous system involvement
boolean
C4050309 (UMLS CUI [1])
Cardiac status
Item
cardiac status as described in protocol
boolean
C1999091 (UMLS CUI [1])
Absorption and tolerance of ixazomib
Item
known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption or tolerance of ixazomib - diagnosis of smoldering multiple myeloma, waldenstrom's macroglobulinemia, poems syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
boolean
C0017178 (UMLS CUI [1,1])
C0524722 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0392678 (UMLS CUI [1,4])
C0237442 (UMLS CUI [1,5])
C0175795 (UMLS CUI [1,6])
C3273711 (UMLS CUI [1,7])
Infection and immunodeficiency
Item
known human immunodeficiency virus (hiv) positive, hepatitis b surface antigen-positive status, or known or suspected active hepatitis c infection
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019196 (UMLS CUI [3,1])
C0009450 (UMLS CUI [3,2])
C0205177 (UMLS CUI [3,3])
Other malignancy
Item
diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0543478 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Comorbidities
Item
serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
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