ID

30835

Beschreibung

A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b; ODM derived from: https://clinicaltrials.gov/show/NCT00423644

Link

https://clinicaltrials.gov/show/NCT00423644

Stichworte

Versionen (1)
  1. 25.06.18 25.06.18 -
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See clinicaltrials.gov

Hochgeladen am

25. Juni 2018

DOI

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Eligibility Multiple Myeloma NCT00423644

Englisch

Eligibility Multiple Myeloma NCT00423644

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
Beschreibung

Multiple Myeloma | Protein criteria Measurable | Response Evaluation | Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0033684
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1513040
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C1261322
UMLS CUI [4]
C1513041
1. serum m-protein level > 0.5 gm/dl (10.0 g/l) measured by serum protein electrophoresis.
Beschreibung

M Protein Serum Level | Serum protein electrophoresis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0441889
UMLS CUI [2]
C0201720
2. urinary m-protein excretion > 0.2 g/24 hours by urine electrophoresis.
Beschreibung

M Protein urinary Excretion | Urine electrophoresis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C1524119
UMLS CUI [1,3]
C0221102
UMLS CUI [2]
C0853361
2. subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. a minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
Beschreibung

Recurrent disease | Disease Resistant | Line of Therapy Quantity Myeloma | Transplantation, Autologous | Transplantation, Homologous

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332325
UMLS CUI [3,1]
C4524693
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0026764
UMLS CUI [4]
C0040736
UMLS CUI [5]
C0040739
3. informed consent compliant with ziopharm policies and approved by the human investigation review committee with jurisdiction over the site;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
4. ecog performance score ≤ 1;
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. no chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
Beschreibung

Chemotherapy Absent | Bortezomib Absent | Lenalidomide Absent | Thalidomide Absent | Arsenic trioxide Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Toxicity Due to Therapeutic procedure | Patient recovered | Prednisone U/day Equivalent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1176309
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1144149
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0039736
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0052416
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0021083
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0600688
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0087111
UMLS CUI [9]
C1115804
UMLS CUI [10,1]
C0032952
UMLS CUI [10,2]
C0456683
UMLS CUI [10,3]
C0205163
6. age ≥ 18;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. granulocytes ≥ 1.0 x 109/l; platelets ≥ 50 x 109/l;
Beschreibung

Granulocyte count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
8. bilirubin ≤ 2.0 mg/dl; ast and alt ≤ 2 x uln;
Beschreibung

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
9. creatinine ≤ 3 x uln.
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
10. no investigational agents within 28 days of study entry.
Beschreibung

Investigational New Drugs Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332197
11. males who agree to use a double-barrier method of birth control, (double barrier method is defined as: a condom and either a diaphragm/cervical cap or an iud).
Beschreibung

Gender Barrier Contraception Double | Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
UMLS CUI [2]
C0677582
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0493327
UMLS CUI [5]
C0021900
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nyha functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; qtc ≥ 450msec; av-block ≥
Beschreibung

New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Exception ATRIAL FIBRILLATION ASYMPTOMATIC | QTc

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0741277
UMLS CUI [5]
C0860814
grade-2 or lbbb;
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3]
C0023211
2. women of childbearing potential. (non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
Beschreibung

Childbearing Potential | Female Sterilization Absent | Postmenopausal state Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
3. active infection requiring antibiotics;
Beschreibung

Communicable Disease Requirement Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
4. allergy to zio-101 or its excipients;
Beschreibung

Hypersensitivity ZIO 101 | Hypersensitivity ZIO 101 Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2713972
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2713972
UMLS CUI [2,3]
C0015237
5. baseline confusion or dementia, defined as grade > 2 ctcae version 3.0;
Beschreibung

CONFUSION BASELINE CTCAE Grades | Dementia CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742735
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C1516728
6. significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per ctcae version 3.0;
Beschreibung

Neurotoxicity CTCAE Grades | Neuropathology CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0876934
UMLS CUI [2,2]
C1516728
7. prior seizures ≥ grade-3 in ctc v.3 criteria.
Beschreibung

Seizures CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C1516728
8. prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
Beschreibung

Neurologic Deficits Interfere with Neurologic Examination Post-dose | Cerebrovascular accident | Dementia | Ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521654
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0027853
UMLS CUI [1,4]
C0439568
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0022116
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00423644

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Protein criteria Measurable | Response Evaluation | Measurable Disease
Item
1. subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
boolean
C0026764 (UMLS CUI [1])
C0033684 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C1704632 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
M Protein Serum Level | Serum protein electrophoresis
Item
1. serum m-protein level > 0.5 gm/dl (10.0 g/l) measured by serum protein electrophoresis.
boolean
C0700271 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C0201720 (UMLS CUI [2])
M Protein urinary Excretion | Urine electrophoresis
Item
2. urinary m-protein excretion > 0.2 g/24 hours by urine electrophoresis.
boolean
C0700271 (UMLS CUI [1,1])
C1524119 (UMLS CUI [1,2])
C0221102 (UMLS CUI [1,3])
C0853361 (UMLS CUI [2])
Recurrent disease | Disease Resistant | Line of Therapy Quantity Myeloma | Transplantation, Autologous | Transplantation, Homologous
Item
2. subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. a minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
boolean
C0277556 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C4524693 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0026764 (UMLS CUI [3,3])
C0040736 (UMLS CUI [4])
C0040739 (UMLS CUI [5])
Informed Consent
Item
3. informed consent compliant with ziopharm policies and approved by the human investigation review committee with jurisdiction over the site;
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance score ≤ 1;
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Absent | Bortezomib Absent | Lenalidomide Absent | Thalidomide Absent | Arsenic trioxide Absent | Therapeutic radiology procedure Absent | Immunotherapy Absent | Toxicity Due to Therapeutic procedure | Patient recovered | Prednisone U/day Equivalent
Item
5. no chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1176309 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1144149 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0039736 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0052416 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0021083 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0600688 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
C1115804 (UMLS CUI [9])
C0032952 (UMLS CUI [10,1])
C0456683 (UMLS CUI [10,2])
C0205163 (UMLS CUI [10,3])
Age
Item
6. age ≥ 18;
boolean
C0001779 (UMLS CUI [1])
Granulocyte count | Platelet Count measurement
Item
7. granulocytes ≥ 1.0 x 109/l; platelets ≥ 50 x 109/l;
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
8. bilirubin ≤ 2.0 mg/dl; ast and alt ≤ 2 x uln;
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Creatinine measurement, serum
Item
9. creatinine ≤ 3 x uln.
boolean
C0201976 (UMLS CUI [1])
Investigational New Drugs Absent
Item
10. no investigational agents within 28 days of study entry.
boolean
C0013230 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Gender Barrier Contraception Double | Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices
Item
11. males who agree to use a double-barrier method of birth control, (double barrier method is defined as: a condom and either a diaphragm/cervical cap or an iud).
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0677582 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0493327 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Exception ATRIAL FIBRILLATION ASYMPTOMATIC | QTc
Item
1. nyha functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; qtc ≥ 450msec; av-block ≥
boolean
C1275491 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0741277 (UMLS CUI [4,2])
C0860814 (UMLS CUI [5])
Second degree atrioventricular block | Complete atrioventricular block | Left Bundle-Branch Block
Item
grade-2 or lbbb;
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0023211 (UMLS CUI [3])
Childbearing Potential | Female Sterilization Absent | Postmenopausal state Absent
Item
2. women of childbearing potential. (non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
boolean
C3831118 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Communicable Disease Requirement Antibiotics
Item
3. active infection requiring antibiotics;
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Hypersensitivity ZIO 101 | Hypersensitivity ZIO 101 Excipient
Item
4. allergy to zio-101 or its excipients;
boolean
C0020517 (UMLS CUI [1,1])
C2713972 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2713972 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
CONFUSION BASELINE CTCAE Grades | Dementia CTCAE Grades
Item
5. baseline confusion or dementia, defined as grade > 2 ctcae version 3.0;
boolean
C0742735 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Neurotoxicity CTCAE Grades | Neuropathology CTCAE Grades
Item
6. significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per ctcae version 3.0;
boolean
C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0876934 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Seizures CTCAE Grades
Item
7. prior seizures ≥ grade-3 in ctc v.3 criteria.
boolean
C0036572 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Neurologic Deficits Interfere with Neurologic Examination Post-dose | Cerebrovascular accident | Dementia | Ischemia
Item
8. prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
boolean
C0521654 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0027853 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
C0038454 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0022116 (UMLS CUI [4])
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