ID

30860

Beschrijving

Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00670631

Link

https://clinicaltrials.gov/show/NCT00670631

Trefwoorden

Versies (1)
  1. 27-06-18 27-06-18 -
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See clinicaltrials.gov

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27 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00670631

Engels

Eligibility Multiple Myeloma NCT00670631

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have the diagnosis of active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
Beschrijving

Multiple Myeloma Treatment required for | Smoldering myeloma | Progressive Disease Requirement Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C1531608
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0392920
2. protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain, bence-jones protein, or free kappa light chain or free lambda light chain) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas or focal lesions on mri.
Beschrijving

Protein Criteria Present | M component present IgG | M component present IgA | M component present IgD | M component present IgE | Urine kappa light chain measurement | Urine lambda light chain measurement | Bence Jones Protein | Free kappa light chain | Free lambda light chain | Response Evaluation | Non-secretory myeloma | Plasmacytosis Percentage MRI | Plasmacytoma Focal Multiple MRI | Lesion Focal Multiple MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033684
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C0150312
UMLS CUI [2,1]
C2363751
UMLS CUI [2,2]
C0020852
UMLS CUI [3,1]
C2363751
UMLS CUI [3,2]
C0020835
UMLS CUI [4,1]
C2363751
UMLS CUI [4,2]
C0020843
UMLS CUI [5,1]
C2363751
UMLS CUI [5,2]
C0020846
UMLS CUI [6]
C1445960
UMLS CUI [7]
C1445961
UMLS CUI [8]
C0004965
UMLS CUI [9]
C0443743
UMLS CUI [10]
C0443744
UMLS CUI [11,1]
C1704632
UMLS CUI [11,2]
C1261322
UMLS CUI [12]
C0456845
UMLS CUI [13,1]
C0085663
UMLS CUI [13,2]
C0439165
UMLS CUI [13,3]
C0024485
UMLS CUI [14,1]
C0032131
UMLS CUI [14,2]
C0205234
UMLS CUI [14,3]
C0439064
UMLS CUI [14,4]
C0024485
UMLS CUI [15,1]
C0221198
UMLS CUI [15,2]
C0205234
UMLS CUI [15,3]
C0439064
UMLS CUI [15,4]
C0024485
3. patients must have received no more than 12 months of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
Beschrijving

Prior Chemotherapy | Prior radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
4. patients must be 18-75 years of age at the time of initial registration.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. ejection fraction by echo or muga ≥ 40% performed within 60 days prior to registration.
Beschrijving

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
6. patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc) and diffusion capacity (dlco) > 50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
Beschrijving

Pulmonary function tests | FEV1 | FVC | Diffusion capacity of lung, function | Carbon Monoxide Diffusing Capability Test | Exception Therapeutic procedure High dose Anticipated

Datatype

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C0231971
UMLS CUI [5]
C1516251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C0444956
UMLS CUI [6,4]
C3840775
7. patients must have a creatinine < 3 mg/dl and a creatinine clearance >30ml/min
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
8. patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain will be eligible.
Beschrijving

Performance status SWOG Criteria | Poor performance status Relationship Bone pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C1519429
UMLS CUI [1,3]
C0243161
UMLS CUI [2,1]
C1831741
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0151825
9. all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. platelet count < 30 x 109/l, unless myeloma-related.
Beschrijving

Platelet Count measurement | Exception Relationship Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0026764
2. greater than a grade 2 peripheral neuropathy.
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
3. hypersensitivity to bortezomib, boron, or mannitol.
Beschrijving

Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy

Datatype

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]
C0571922
4. uncontrolled diabetes.
Beschrijving

Diabetic - poor control

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
5. recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
Beschrijving

Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0742800
UMLS CUI [4]
C1868885
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0742800
6. evidence of chronic obstructive or chronic restrictive pulmonary disease.
Beschrijving

Chronic Obstructive Airway Disease | Restrictive lung disease chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2,1]
C0085581
UMLS CUI [2,2]
C0205191
7. patients must not have light chain deposition disease-related renal failure or creatinine > 3 mg/dl.
Beschrijving

Kidney Failure Relationship Light chain disease | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0238239
UMLS CUI [2]
C0201976
8. patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds five years.
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Untreated Duration | Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C0332155
UMLS CUI [5,4]
C0449238
UMLS CUI [6]
C0023671
9. patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
Beschrijving

Comorbidity Significant | Communicable Disease Life Threatening Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0205318
10. pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
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Similar models

Eligibility Multiple Myeloma NCT00670631

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Treatment required for | Smoldering myeloma | Progressive Disease Requirement Chemotherapy
Item
1. patients must have the diagnosis of active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Protein Criteria Present | M component present IgG | M component present IgA | M component present IgD | M component present IgE | Urine kappa light chain measurement | Urine lambda light chain measurement | Bence Jones Protein | Free kappa light chain | Free lambda light chain | Response Evaluation | Non-secretory myeloma | Plasmacytosis Percentage MRI | Plasmacytoma Focal Multiple MRI | Lesion Focal Multiple MRI
Item
2. protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain, bence-jones protein, or free kappa light chain or free lambda light chain) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas or focal lesions on mri.
boolean
C0033684 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C2363751 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C2363751 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C2363751 (UMLS CUI [4,1])
C0020843 (UMLS CUI [4,2])
C2363751 (UMLS CUI [5,1])
C0020846 (UMLS CUI [5,2])
C1445960 (UMLS CUI [6])
C1445961 (UMLS CUI [7])
C0004965 (UMLS CUI [8])
C0443743 (UMLS CUI [9])
C0443744 (UMLS CUI [10])
C1704632 (UMLS CUI [11,1])
C1261322 (UMLS CUI [11,2])
C0456845 (UMLS CUI [12])
C0085663 (UMLS CUI [13,1])
C0439165 (UMLS CUI [13,2])
C0024485 (UMLS CUI [13,3])
C0032131 (UMLS CUI [14,1])
C0205234 (UMLS CUI [14,2])
C0439064 (UMLS CUI [14,3])
C0024485 (UMLS CUI [14,4])
C0221198 (UMLS CUI [15,1])
C0205234 (UMLS CUI [15,2])
C0439064 (UMLS CUI [15,3])
C0024485 (UMLS CUI [15,4])
Prior Chemotherapy | Prior radiation therapy
Item
3. patients must have received no more than 12 months of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Age
Item
4. patients must be 18-75 years of age at the time of initial registration.
boolean
C0001779 (UMLS CUI [1])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
5. ejection fraction by echo or muga ≥ 40% performed within 60 days prior to registration.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Pulmonary function tests | FEV1 | FVC | Diffusion capacity of lung, function | Carbon Monoxide Diffusing Capability Test | Exception Therapeutic procedure High dose Anticipated
Item
6. patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc) and diffusion capacity (dlco) > 50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C0231971 (UMLS CUI [4])
C1516251 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0444956 (UMLS CUI [6,3])
C3840775 (UMLS CUI [6,4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
7. patients must have a creatinine < 3 mg/dl and a creatinine clearance >30ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Performance status SWOG Criteria | Poor performance status Relationship Bone pain
Item
8. patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain will be eligible.
boolean
C1518965 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1831741 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0151825 (UMLS CUI [2,3])
Informed Consent
Item
9. all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Platelet Count measurement | Exception Relationship Myeloma
Item
1. platelet count < 30 x 109/l, unless myeloma-related.
boolean
C0032181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Peripheral Neuropathy CTCAE Grades
Item
2. greater than a grade 2 peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
3. hypersensitivity to bortezomib, boron, or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Diabetic - poor control
Item
4. uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT
Item
5. recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0742800 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
Chronic Obstructive Airway Disease | Restrictive lung disease chronic
Item
6. evidence of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
C0085581 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Kidney Failure Relationship Light chain disease | Creatinine measurement, serum
Item
7. patients must not have light chain deposition disease-related renal failure or creatinine > 3 mg/dl.
boolean
C0035078 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0238239 (UMLS CUI [1,3])
C0201976 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Untreated Duration | Life Expectancy
Item
8. patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds five years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C0023671 (UMLS CUI [6])
Comorbidity Significant | Communicable Disease Life Threatening Uncontrolled
Item
9. patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods
Item
10. pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
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