ID

44801

Description

Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone; ODM derived from: https://clinicaltrials.gov/show/NCT01237249

Link

https://clinicaltrials.gov/show/NCT01237249

Keywords

  1. 12/1/21 12/1/21 - Tabea Kampen
Copyright Holder

PETHEMA Foundation

Uploaded on

December 1, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT01237249

Eligibility Multiple Myeloma NCT01237249

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent obtained before starting any study-specific procedure.
Description

Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
symptomatic elderly MM newly diagnosed by ebmt criteria older than 65 years.
Description

Multiple myeloma diagnosis EBMT Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C0026764
UMLS CUI [1,3]
C3826859
UMLS CUI [1,4]
C0001779
performance status (ecog) ≤ 2.
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization: - platelet count ≥ 75x109/L - haemoglobin ≥ 8g/dL - absolute neutrophil count (ANC) ≥ 1.0x109/L - Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN - Serum creatinine ≤2,5 mg/dl
Description

Lab values

Data type

boolean

Alias
UMLS CUI [1,1]
C1527021
UMLS CUI [1,2]
C1948041
UMLS CUI [1,3]
C0022877
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0948762
UMLS CUI [5,1]
C1278039
UMLS CUI [5,2]
C0201850
UMLS CUI [6]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient previously received treatment with velcade or revlimid.
Description

Previous treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1174739
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1135145
patient previously received treatment for multiple myeloma.
Description

Pre-treatment for multiple myeloma

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514463
patient has ≥ grade 2 peripheral neuropathy within 14 days before enrolment.
Description

Peripheral neuropathy CTCAE

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C0521116
patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1144149
patient has received other investigational drugs with 28 days before enrolment.
Description

Other investigational drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2348568
patient had a myocardial infarction within 6 months of enrolment or has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Description

Cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C1275491
UMLS CUI [2,2]
C0018801
UMLS CUI [3,1]
C0205318
UMLS CUI [3,2]
C0002965
UMLS CUI [4]
C0085612
UMLS CUI [5]
C3900108
UMLS CUI [6]
C0151236
patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
Description

Other clinical research study

Data type

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C3840932
radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas
Description

Radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0436323
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0032131
UMLS CUI [2,5]
C1444656

Similar models

Eligibility Multiple Myeloma NCT01237249

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Consent
Item
written informed consent obtained before starting any study-specific procedure.
boolean
C0021430 (UMLS CUI [1])
Multiple myeloma diagnosis EBMT Criteria
Item
symptomatic elderly MM newly diagnosed by ebmt criteria older than 65 years.
boolean
C0231220 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C3826859 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
ECOG
Item
performance status (ecog) ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Lab values
Item
have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization: - platelet count ≥ 75x109/L - haemoglobin ≥ 8g/dL - absolute neutrophil count (ANC) ≥ 1.0x109/L - Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN - Serum creatinine ≤2,5 mg/dl
boolean
C1527021 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C1278039 (UMLS CUI [5,1])
C0201850 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Previous treatment
Item
patient previously received treatment with velcade or revlimid.
boolean
C0087111 (UMLS CUI [1,1])
C1174739 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1135145 (UMLS CUI [2,2])
Pre-treatment for multiple myeloma
Item
patient previously received treatment for multiple myeloma.
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Peripheral neuropathy CTCAE
Item
patient has ≥ grade 2 peripheral neuropathy within 14 days before enrolment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Hypersensitivity
Item
patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1144149 (UMLS CUI [4,2])
Other investigational drugs
Item
patient has received other investigational drugs with 28 days before enrolment.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Cardiac function
Item
patient had a myocardial infarction within 6 months of enrolment or has new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
C0027051 (UMLS CUI [1])
C1275491 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0205318 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4])
C3900108 (UMLS CUI [5])
C0151236 (UMLS CUI [6])
Other clinical research study
Item
patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
boolean
C0008972 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C3840932 (UMLS CUI [2,2])
Radiation therapy
Item
radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas
boolean
C1522449 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0436323 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0032131 (UMLS CUI [2,4])
C1444656 (UMLS CUI [2,5])

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