ID

30921

Description

Safety And Efficacy Of Lenalidomide As Maintenance Therapy In Patients With Newly Diagnosed Multiple Myeloma Following A Tandem Autologous-Allogeneic Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01264315

Link

https://clinicaltrials.gov/show/NCT01264315

Keywords

Versions (1)
  1. 7/3/18 7/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01264315

English

Eligibility Multiple Myeloma NCT01264315

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. newly diagnosed multiple myeloma patients with an hla identical sibling suitable for pbsc donation and treated in induction with thalidomide or bortezomib or lenalidomide conteining regimes.
Description

Multiple Myeloma | HLA Identical Sibling | Sibling Appropriate Peripheral Blood Stem Cell Donation | Induction Therapy | Thalidomide | Bortezomib | Lenalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0019721
UMLS CUI [2,2]
C0205280
UMLS CUI [2,3]
C0037047
UMLS CUI [3,1]
C0037047
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C1518999
UMLS CUI [3,4]
C0080231
UMLS CUI [4]
C0600558
UMLS CUI [5]
C0039736
UMLS CUI [6]
C1176309
UMLS CUI [7]
C1144149
2. complete cytogenetic analysis at diagnosis, including fish analysis for chromosome deletions 13 and 17, and translocations (4;14) (11;14) and (14;16).
Description

Cytogenetic Analysis | del(13) FISH | del(17) FISH | t(4;14) FISH | t(11;14) FISH | t(14;16) FISH

Data type

boolean

Alias
UMLS CUI [1]
C0752095
UMLS CUI [2,1]
C1517957
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C1517964
UMLS CUI [3,2]
C0162789
UMLS CUI [4,1]
C2986942
UMLS CUI [4,2]
C0162789
UMLS CUI [5,1]
C4287831
UMLS CUI [5,2]
C0162789
UMLS CUI [6,1]
C2986943
UMLS CUI [6,2]
C0162789
3. the patient must have the capacity to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. age >18 and < 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. if female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study
Description

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Contraceptive methods Double | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205173
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0221829
6. if male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study
Description

Gender Sexual Abstinence | Gender Latex condom | Partner Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3873750
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C3831118
7. negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. karnofsky score less than 60 (see appendix c), unless due solely to myeloma
Description

Karnofsky Performance Status | Exception Due to Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0026764
2. left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy
Description

Left ventricular ejection fraction | Coronary Artery Disease Symptomatic | Heart failure Treatment required for

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0332121
3. bilirubin greater than 2 x the upper limit of normal, or sgpt and sgot > 4 x the upper limit of normal
Description

Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
4. dlco < 40% (corrected) or receiving continuous supplemental oxygen.
Description

Carbon Monoxide Diffusing Capability Test Corrected | Supplemental oxygen

Data type

boolean

Alias
UMLS CUI [1,1]
C1516251
UMLS CUI [1,2]
C0205202
UMLS CUI [2]
C4534306
5. creatinine clearance < 40 cc/min at the time of initial autografting evaluation.
Description

Creatinine clearance measurement | Autografting Evaluation Initial

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C0040736
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0205265
6. patients with poorly controlled hypertension
Description

Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0421190
7. patients with active non-hematologic malignancies (except non-melanoma skin cancers).
Description

Non-Hematologic Malignancy | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0935681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
8. patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence
Description

Non-Hematologic Malignancy | Exception Skin carcinoma | In complete remission | Risk Percentage Disease recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0935681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3]
C0677874
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0679254
9. seropositive for hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
10. fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
Description

Fertility Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
11. to evaluate toxicity and tolerability of lenalidomide after allografting
Description

Toxicity Evaluation | Evaluation Patient Tolerable Lenalidomide | Status post Allografting

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1261322
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C4053931
UMLS CUI [2,4]
C1144149
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0040739
12. to evaluate efficacy of lenalidomide in inducing complete remission 12 months after allografting
Description

Evaluation Effectiveness Lenalidomide | Induction Complete remission | Status post Allografting

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C1144149
UMLS CUI [2,1]
C0205263
UMLS CUI [2,2]
C0677874
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0040739
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Similar models

Eligibility Multiple Myeloma NCT01264315

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | HLA Identical Sibling | Sibling Appropriate Peripheral Blood Stem Cell Donation | Induction Therapy | Thalidomide | Bortezomib | Lenalidomide
Item
1. newly diagnosed multiple myeloma patients with an hla identical sibling suitable for pbsc donation and treated in induction with thalidomide or bortezomib or lenalidomide conteining regimes.
boolean
C0026764 (UMLS CUI [1])
C0019721 (UMLS CUI [2,1])
C0205280 (UMLS CUI [2,2])
C0037047 (UMLS CUI [2,3])
C0037047 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C1518999 (UMLS CUI [3,3])
C0080231 (UMLS CUI [3,4])
C0600558 (UMLS CUI [4])
C0039736 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
C1144149 (UMLS CUI [7])
Cytogenetic Analysis | del(13) FISH | del(17) FISH | t(4;14) FISH | t(11;14) FISH | t(14;16) FISH
Item
2. complete cytogenetic analysis at diagnosis, including fish analysis for chromosome deletions 13 and 17, and translocations (4;14) (11;14) and (14;16).
boolean
C0752095 (UMLS CUI [1])
C1517957 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1517964 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C2986942 (UMLS CUI [4,1])
C0162789 (UMLS CUI [4,2])
C4287831 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C2986943 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
Informed Consent
Item
3. the patient must have the capacity to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. age >18 and < 65
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Contraceptive methods Double | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms
Item
5. if female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C2985296 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
Gender Sexual Abstinence | Gender Latex condom | Partner Childbearing Potential
Item
6. if male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C3873750 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
Pregnancy test negative
Item
7. negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status | Exception Due to Multiple Myeloma
Item
1. karnofsky score less than 60 (see appendix c), unless due solely to myeloma
boolean
C0206065 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Left ventricular ejection fraction | Coronary Artery Disease Symptomatic | Heart failure Treatment required for
Item
2. left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy
boolean
C0428772 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
3. bilirubin greater than 2 x the upper limit of normal, or sgpt and sgot > 4 x the upper limit of normal
boolean
C0741494 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Carbon Monoxide Diffusing Capability Test Corrected | Supplemental oxygen
Item
4. dlco < 40% (corrected) or receiving continuous supplemental oxygen.
boolean
C1516251 (UMLS CUI [1,1])
C0205202 (UMLS CUI [1,2])
C4534306 (UMLS CUI [2])
Creatinine clearance measurement | Autografting Evaluation Initial
Item
5. creatinine clearance < 40 cc/min at the time of initial autografting evaluation.
boolean
C0373595 (UMLS CUI [1])
C0040736 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
Poor hypertension control
Item
6. patients with poorly controlled hypertension
boolean
C0421190 (UMLS CUI [1])
Non-Hematologic Malignancy | Exception Skin carcinoma
Item
7. patients with active non-hematologic malignancies (except non-melanoma skin cancers).
boolean
C0935681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Non-Hematologic Malignancy | Exception Skin carcinoma | In complete remission | Risk Percentage Disease recurrence
Item
8. patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence
boolean
C0935681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3])
C0035647 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0679254 (UMLS CUI [4,3])
HIV Seropositivity
Item
9. seropositive for hiv
boolean
C0019699 (UMLS CUI [1])
Fertility Contraceptive methods Unwilling
Item
10. fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Toxicity Evaluation | Evaluation Patient Tolerable Lenalidomide | Status post Allografting
Item
11. to evaluate toxicity and tolerability of lenalidomide after allografting
boolean
C0600688 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C4053931 (UMLS CUI [2,3])
C1144149 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0040739 (UMLS CUI [3,2])
Evaluation Effectiveness Lenalidomide | Induction Complete remission | Status post Allografting
Item
12. to evaluate efficacy of lenalidomide in inducing complete remission 12 months after allografting
boolean
C1261322 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,3])
C0205263 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0040739 (UMLS CUI [3,2])
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