ID

21950

Description

Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00415064

Link

https://clinicaltrials.gov/show/NCT00415064

Keywords

Versions (1)
  1. 5/9/17 5/9/17 -
Uploaded on

May 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00415064

English

Eligibility Multiple Myeloma NCT00415064

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows.
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
major criteria:
Description

Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1542147
1. plasmacytomas on tissue biopsy.
Description

Plasmacytoma Biopsy tissue

Data type

boolean

Alias
UMLS CUI [1,1]
C0032131
UMLS CUI [1,2]
C3864006
2. bone marrow plasmacytosis (> 30% plasma cells).
Description

BONE MARROW PLASMACYTOSIS Plasma Cells Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0238803
UMLS CUI [1,2]
C0032112
UMLS CUI [1,3]
C0439165
3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) >3.5 g/dl or immunoglobulin a (iga) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
Description

Monoclonal immunoglobulin present | Serum electrophoresis Immunoglobulin G | Serum electrophoresis Immunoglobulin A | Free kappa light chain Excretion | Free lambda light chain Excretion | 24-hour urine protein electrophoresis

Data type

boolean

Alias
UMLS CUI [1]
C0860896
UMLS CUI [2,1]
C0851095
UMLS CUI [2,2]
C0020852
UMLS CUI [3,1]
C0851095
UMLS CUI [3,2]
C0020835
UMLS CUI [4,1]
C0443743
UMLS CUI [4,2]
C0221102
UMLS CUI [5,1]
C0443744
UMLS CUI [5,2]
C0221102
UMLS CUI [6]
C2321676
patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
Description

Recurrent disease | Refractory Disease | Disease Progression | Second line treatment Patient need for | Third line treatment Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1710038
UMLS CUI [4,2]
C0686904
UMLS CUI [5,1]
C2986605
UMLS CUI [5,2]
C0686904
patients refractory to a combination of lenalidomide and dexamethasone will not be eligible. patients may have received lenalidomide and/or dexamethasone
Description

lenalidomide | Dexamethasone | Combined Modality Therapy Patients refractory

Data type

boolean

Alias
UMLS CUI [1]
C1144149
UMLS CUI [2]
C0011777
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0030705
UMLS CUI [3,3]
C0205269
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
renal insufficiency (serum creatinine levels > 3 mg/dl)..
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
Description

Allergic Reaction Perifosine Compound Similar | Allergic Reaction Miltefosine Compound Similar | Allergic Reaction Edelfosine Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0754570
UMLS CUI [1,3]
C1706082
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0068006
UMLS CUI [2,3]
C1706082
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0044549
UMLS CUI [3,3]
C1706082
UMLS CUI [3,4]
C2348205
known hypersensitivity to thalidomide
Description

Hypersensitivity Thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
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Similar models

Eligibility Multiple Myeloma NCT00415064

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows.
boolean
C0026764 (UMLS CUI [1])
Criteria Main
Item
major criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Plasmacytoma Biopsy tissue
Item
1. plasmacytomas on tissue biopsy.
boolean
C0032131 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
BONE MARROW PLASMACYTOSIS Plasma Cells Percentage
Item
2. bone marrow plasmacytosis (> 30% plasma cells).
boolean
C0238803 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Monoclonal immunoglobulin present | Serum electrophoresis Immunoglobulin G | Serum electrophoresis Immunoglobulin A | Free kappa light chain Excretion | Free lambda light chain Excretion | 24-hour urine protein electrophoresis
Item
3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) >3.5 g/dl or immunoglobulin a (iga) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
boolean
C0860896 (UMLS CUI [1])
C0851095 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C0851095 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C0443743 (UMLS CUI [4,1])
C0221102 (UMLS CUI [4,2])
C0443744 (UMLS CUI [5,1])
C0221102 (UMLS CUI [5,2])
C2321676 (UMLS CUI [6])
Recurrent disease | Refractory Disease | Disease Progression | Second line treatment Patient need for | Third line treatment Patient need for
Item
patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1710038 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C2986605 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
lenalidomide | Dexamethasone | Combined Modality Therapy Patients refractory
Item
patients refractory to a combination of lenalidomide and dexamethasone will not be eligible. patients may have received lenalidomide and/or dexamethasone
boolean
C1144149 (UMLS CUI [1])
C0011777 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C0030705 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum
Item
renal insufficiency (serum creatinine levels > 3 mg/dl)..
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Allergic Reaction Perifosine Compound Similar | Allergic Reaction Miltefosine Compound Similar | Allergic Reaction Edelfosine Compound Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
boolean
C1527304 (UMLS CUI [1,1])
C0754570 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0068006 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C0044549 (UMLS CUI [3,2])
C1706082 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
Hypersensitivity Thalidomide
Item
known hypersensitivity to thalidomide
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
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