ID

41815

Description

Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01177683

Link

https://clinicaltrials.gov/show/NCT01177683

Keywords

Versions (2)
  1. 1/21/21 1/21/21 - Ahmed Rafee, MD
  2. 1/22/21 1/22/21 - Ahmed Rafee, MD
Copyright Holder

Sherif Farag, MB, BS

Uploaded on

January 22, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01177683

English

Eligibility Multiple Myeloma NCT01177683

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
Description

Multiple Myeloma; histological diagnosis with Relapse | Multiple Myeloma; histological diagnosis with Relaps Unresponsive to treatment (Refractory)

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0035020
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0679557
UMLS CUI [2,3]
C0205269
must have a detectable serum or urine m-protein by protein electrophoresis that is at least 500 mg/dl (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain.
Description

M-Protien; Serum Protein Electrophoresis | M-Protien; Urine Protein Electrophoresis | Free light chain; measurement; serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0201720
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0201721
UMLS CUI [3,1]
C0806492
UMLS CUI [3,2]
C0229671
must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
Description

At least one systemic therapy; must include lenalidomide | At least one systemic therapy; must include thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C1144149
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0750480
UMLS CUI [2,3]
C0039736
must be willing to provide correlative blood samples.
Description

Collecting blood specimens; willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
must not have received an excessive cumulative dose of anthracycline
Description

Anthracycline; excessive cumulative dose; absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C2986497
UMLS CUI [1,4]
C0332197
no ≥ grade 2 peripheral neuropathy.
Description

Peripheral Neuropathy; disease grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0441800
no cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
Description

Cytotoxic chemotherapy; absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332197
no autologous stem cell transplant within 6 months prior to registration for protocol therapy
Description

Autologous stem cell transplant, absent

Data type

boolean

Alias
UMLS CUI [1,1]
C2193200
UMLS CUI [1,2]
C0332197
no prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy.
Description

see study procedures manual to calculate percent of prior radiation.

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C1550653
UMLS CUI [1,4]
C0439792
UMLS CUI [1,5]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0030797
UMLS CUI [2,3]
C0332197
no current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
Description

Current dose of corticosteroids for other indications

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C3146298
UMLS CUI [1,5]
C0205394
no known central nervous system involvement by myeloma.
Description

Multiple Myeloma; CNS involvement status; absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0449389
UMLS CUI [1,3]
C0332197
no poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
Description

no poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.

Data type

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0004936
UMLS CUI [7,1]
C0037414
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
no patients known to be positive for hiv, or active hepatitis a, b, or c.
Description

HIV seropositivity | Active Hepatitis A, B or C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019159
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0019163
UMLS CUI [3,2]
C0205177
UMLS CUI [4,1]
C0019196
UMLS CUI [4,2]
C0205177
no major surgery within 30 days prior to registration for protocol therapy. placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
Description

Recent major surgery | recent insertion of CVC

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3521108
UMLS CUI [2,3]
C0332185
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Similar models

Eligibility Multiple Myeloma NCT01177683

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma; histological diagnosis with Relapse | Multiple Myeloma; histological diagnosis with Relaps Unresponsive to treatment (Refractory)
Item
a histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
boolean
C0026764 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
C0026764 (UMLS CUI [2,1])
C0679557 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
M-Protien; Serum Protein Electrophoresis | M-Protien; Urine Protein Electrophoresis | Free light chain; measurement; serum
Item
must have a detectable serum or urine m-protein by protein electrophoresis that is at least 500 mg/dl (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level >100 mg/l for the involved free light chain.
boolean
C0700271 (UMLS CUI [1,1])
C0201720 (UMLS CUI [1,2])
C0700271 (UMLS CUI [2,1])
C0201721 (UMLS CUI [2,2])
C0806492 (UMLS CUI [3,1])
C0229671 (UMLS CUI [3,2])
At least one systemic therapy; must include lenalidomide | At least one systemic therapy; must include thalidomide
Item
must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
boolean
C1515119 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,3])
C1515119 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0039736 (UMLS CUI [2,3])
Collecting blood specimens; willing
Item
must be willing to provide correlative blood samples.
boolean
C0005834 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Anthracycline; excessive cumulative dose; absent
Item
must not have received an excessive cumulative dose of anthracycline
boolean
C0282564 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Peripheral Neuropathy; disease grade
Item
no ≥ grade 2 peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Cytotoxic chemotherapy; absent
Item
no cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
boolean
C0677881 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Autologous stem cell transplant, absent
Item
no autologous stem cell transplant within 6 months prior to registration for protocol therapy
boolean
C2193200 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Radiation Therapy; Marrow Bone (specimen entity type); Percentage; absent; radiation of Pelvis; absent
Item
no prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy.
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1550653 (UMLS CUI [1,3])
C0439792 (UMLS CUI [1,4])
C0332197 (UMLS CUI [1,5])
C1522449 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Current dose of corticosteroids for other indications
Item
no current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
boolean
C0001617 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Multiple Myeloma; CNS involvement status; absent
Item
no known central nervous system involvement by myeloma.
boolean
C0026764 (UMLS CUI [1,1])
C0449389 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
no poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
Item
no poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0037414 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
HIV seropositivity | Active Hepatitis A, B or C
Item
no patients known to be positive for hiv, or active hepatitis a, b, or c.
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0019163 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
Recent major surgery | recent insertion of CVC
Item
no major surgery within 30 days prior to registration for protocol therapy. placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C3521108 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
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