ID

44448

Description

A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01432353

Link

https://clinicaltrials.gov/show/NCT01432353

Keywords

Versions (1)
  1. 9/22/21 9/22/21 -
Copyright Holder

Genentech, Inc.

Uploaded on

September 22, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Multiple Myeloma NCT01432353

English

Eligibility Multiple Myeloma NCT01432353

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients; >/= 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0, 1, or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
relapsed or refractory multiple myeloma for which no effective standard therapy exists
Description

Relapsed multiple myeloma | Refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
one of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
Description

Prior therapy with a proteasome inhibitor | Prior therapy with an immunomodulatory drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1443643
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C1963758
UMLS CUI [2,2]
C1514463
measurable disease as defined by protocol
Description

Measurable disease as defined by protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of monoclonal antibody within 4 weeks before cycle 1, day 1
Description

Recent use of monoclonal antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0332185
treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to cycle 1, day 1
Description

Recent Radiotherapy | Thalidomide | Lenalidomide | Bortezomib | Chemotheraphy | Any investigational anti-cancer agent

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0039736
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C1144149
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C1176309
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332185
UMLS CUI [6,1]
C0920425
UMLS CUI [6,2]
C0013230
UMLS CUI [6,3]
C0332185
toxicities from any previous treatment must be resolved prior to cycle 1, day 1, except for neuropathy
Description

Toxicities from any previous treatment (except neuropathy) must be resolved

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C1514893
UMLS CUI [1,5]
C0442874
UMLS CUI [1,6]
C1705847
completion of autologous stem cell transplant within 100 days prior to cycle 1, day 1
Description

Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1]
C1831743
prior allogeneic stem cell transplant
Description

Allogeneic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C2242529
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Description

History of severe allergic or anaphylactic reactions to monoclonal antibody therapy | History of severe allergic or anaphylactic reactions to recombinant antibody-related fusion proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C0262926
UMLS CUI [2,1]
C0003250
UMLS CUI [2,2]
C0002792
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C0262926
UMLS CUI [3,1]
C0003250
UMLS CUI [3,2]
C0034861
UMLS CUI [3,3]
C0020517
UMLS CUI [3,4]
C0205082
UMLS CUI [3,5]
C0262926
UMLS CUI [4,1]
C0003250
UMLS CUI [4,2]
C0034861
UMLS CUI [4,3]
C0002792
UMLS CUI [4,4]
C0205082
UMLS CUI [4,5]
C0262926
grade > 1 peripheral neuropathy
Description

Grade of peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0441800
active infection at screening or any major episode of infection requiring treatment with iv antibiotics or hospitalization within 4 weeks prior to cycle 1, day 1
Description

Active infection | Recent episode of an infection requiring treatment with iv antibiotics or hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0559680
UMLS CUI [2,4]
C0332185
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0019993
UMLS CUI [3,4]
C0332185
positive for hepatitis b, hepatitis c or hiv infection
Description

Hepatitis B positive | Hepatitis C positive | HIV seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C1446409
UMLS CUI [3]
C0019699
pregnant or lactating women or women who intend to become pregnant within the period of time of this study
Description

Pregnancy | Breast Feeding | Pregnancy planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Multiple Myeloma NCT01432353

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
adult patients; >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Relapsed multiple myeloma | Refractory multiple myeloma
Item
relapsed or refractory multiple myeloma for which no effective standard therapy exists
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
Prior therapy with a proteasome inhibitor | Prior therapy with an immunomodulatory drug
Item
one of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug
boolean
C1443643 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1963758 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
Measurable disease as defined by protocol
Item
measurable disease as defined by protocol
boolean
C1513041 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Recent use of monoclonal antibody
Item
prior use of monoclonal antibody within 4 weeks before cycle 1, day 1
boolean
C0003250 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent Radiotherapy | Thalidomide | Lenalidomide | Bortezomib | Chemotheraphy | Any investigational anti-cancer agent
Item
treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to cycle 1, day 1
boolean
C1522449 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0039736 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1144149 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C1176309 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0920425 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C0332185 (UMLS CUI [6,3])
Toxicities from any previous treatment (except neuropathy) must be resolved
Item
toxicities from any previous treatment must be resolved prior to cycle 1, day 1, except for neuropathy
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514893 (UMLS CUI [1,4])
C0442874 (UMLS CUI [1,5])
C1705847 (UMLS CUI [1,6])
Transplantation of autologous hematopoietic stem cell
Item
completion of autologous stem cell transplant within 100 days prior to cycle 1, day 1
boolean
C1831743 (UMLS CUI [1])
Allogeneic Stem Cell Transplantation
Item
prior allogeneic stem cell transplant
boolean
C2242529 (UMLS CUI [1])
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy | History of severe allergic or anaphylactic reactions to recombinant antibody-related fusion proteins
Item
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
boolean
C0003250 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C0003250 (UMLS CUI [2,1])
C0002792 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
C0003250 (UMLS CUI [3,1])
C0034861 (UMLS CUI [3,2])
C0020517 (UMLS CUI [3,3])
C0205082 (UMLS CUI [3,4])
C0262926 (UMLS CUI [3,5])
C0003250 (UMLS CUI [4,1])
C0034861 (UMLS CUI [4,2])
C0002792 (UMLS CUI [4,3])
C0205082 (UMLS CUI [4,4])
C0262926 (UMLS CUI [4,5])
Grade of peripheral neuropathy
Item
grade > 1 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Active infection | Recent episode of an infection requiring treatment with iv antibiotics or hospitalization
Item
active infection at screening or any major episode of infection requiring treatment with iv antibiotics or hospitalization within 4 weeks prior to cycle 1, day 1
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0559680 (UMLS CUI [2,3])
C0332185 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0019993 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
Hepatitis B positive | Hepatitis C positive | HIV seropositivity
Item
positive for hepatitis b, hepatitis c or hiv infection
boolean
C0019163 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy planned
Item
pregnant or lactating women or women who intend to become pregnant within the period of time of this study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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