ID

41815

Beschreibung

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

Stichworte

Versionen (2)
  1. 21.01.21 21.01.21 - Ahmed Rafee, MD
  2. 22.01.21 22.01.21 - Ahmed Rafee, MD
Rechteinhaber

Sherif Farag, MB, BS

Hochgeladen am

22. Januar 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01177683

Englisch

Eligibility Multiple Myeloma NCT01177683

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Collecting blood specimens; willing

Datentyp

boolean

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

Exclusion Criteria

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

Anthracycline; excessive cumulative dose; absent

Datentyp

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.
Beschreibung

Peripheral Neuropathy; disease grade

Datentyp

boolean

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

Cytotoxic chemotherapy; absent

Datentyp

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
Beschreibung

Autologous stem cell transplant, absent

Datentyp

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.
Beschreibung

see study procedures manual to calculate percent of prior radiation.

Datentyp

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.
Beschreibung

Current dose of corticosteroids for other indications

Datentyp

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.
Beschreibung

Multiple Myeloma; CNS involvement status; absent

Datentyp

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.
Beschreibung

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.

Datentyp

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.
Beschreibung

HIV seropositivity | Active Hepatitis A, B or C

Datentyp

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.
Beschreibung

Recent major surgery | recent insertion of CVC

Datentyp

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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Ähnliche Modelle

Eligibility Multiple Myeloma NCT01177683

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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