ID

15516

Beschreibung

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02252172

Link

https://clinicaltrials.gov/show/NCT02252172

Stichworte

Versionen (1)
  1. 02.06.16 02.06.16 -
Hochgeladen am

2. Juni 2016

DOI

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Eligibility Multiple Myeloma DRKS00007830 NCT02252172

Englisch

Eligibility Multiple Myeloma NCT02252172

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant must have documented multiple myeloma and measurable disease defined as: 1) monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma; 2) measurable disease as defined by any of the following: (a) immunoglobulin (ig) g myeloma (serum monoclonal paraprotein [m-protein] level >=1.0 gram/deciliter [g/dl] or urine m-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) iga, igm, igd, or ige multiple myeloma (serum m-protein level >=0.5 g/dl or urine m-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio)
Beschreibung

Multiple Myeloma | Measurable Disease | Plasma Cells monoclonal Bone Marrow | Plasmacytoma Biopsy Proven | IgG myeloma | Monoclonal Protein Measurement | Multiple Myeloma-IgA | Multiple Myeloma-IgM | Multiple Myeloma-IgD | Multiple Myeloma-IgE | Multiple Myeloma-Light Chain Only | Serum Free Immunoglobulin Light Chain | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0032112
UMLS CUI [3,2]
C0746619
UMLS CUI [3,3]
C0005953
UMLS CUI [4,1]
C0032131
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C0456369
UMLS CUI [5]
C0563306
UMLS CUI [6]
C2984963
UMLS CUI [7]
C2347300
UMLS CUI [8]
C2347304
UMLS CUI [9]
C2347301
UMLS CUI [10]
C2347302
UMLS CUI [11]
C2347305
UMLS CUI [12]
C2827352
UMLS CUI [13]
C2826181
participant must have an eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. sponsor review and approval of participants below 65 years of age is required before randomization
Beschreibung

Newly Diagnosed | High-dose chemotherapy | Age | Co-morbid conditions | High-dose chemotherapy Consequence Negative | Stem cell transplant Consequence Negative

Datentyp

boolean

Alias
UMLS CUI [1]
C1518321
UMLS CUI [2]
C1328050
UMLS CUI [3]
C0001779
UMLS CUI [4]
C1275743
UMLS CUI [5,1]
C1328050
UMLS CUI [5,2]
C0686907
UMLS CUI [5,3]
C0205160
UMLS CUI [6,1]
C1504389
UMLS CUI [6,2]
C0686907
UMLS CUI [6,3]
C0205160
women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the investigator. contraception must begin 4 weeks prior to dosing
Beschreibung

Childbearing Potential | Sexual Abstinence | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0036899
UMLS CUI [3]
C0700589
man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab
Beschreibung

Males Sexually active | Childbearing Potential | Vasectomy | Contraceptive methods | Sperm donation | Lenalidomide | Daratumumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086582
UMLS CUI [1,2]
C0241028
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0042387
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0871414
UMLS CUI [6]
C1144149
UMLS CUI [7]
C2346801
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum m-protein <3 g/dl; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the m-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
Beschreibung

Primary amyloidosis | Monoclonal Gammapathies | Monoclonal Protein Measurement | Lytic lesion Absent | Anemia | Hypercalcemia | Renal Insufficiency Due to M Protein | Smoldering myeloma | Asymptomatic multiple myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0268381
UMLS CUI [2]
C1136085
UMLS CUI [3]
C2984963
UMLS CUI [4,1]
C0221204
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0002871
UMLS CUI [6]
C0020437
UMLS CUI [7,1]
C1565489
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0700271
UMLS CUI [8]
C1531608
UMLS CUI [9]
C2585107
participant has a diagnosis of waldenström's disease, or other conditions in which igm m protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Beschreibung

Waldenstrom's disease | Medical condition IgM M Protein Present | Plasma cell infiltration Clonal | Lytic lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C0599055
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0020861
UMLS CUI [2,3]
C0700271
UMLS CUI [2,4]
C0150312
UMLS CUI [3,1]
C0391861
UMLS CUI [3,2]
C1522642
UMLS CUI [4]
C0221204
participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
Beschreibung

Malignant Neoplasms | Multiple Myeloma | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0026764
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0007117
UMLS CUI [5]
C0851140
participant has prior or current systemic therapy or sct for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
Beschreibung

systemic therapy Multiple Myeloma | Stem cell transplant Multiple Myeloma | Adrenal Cortex Hormones | Dexamethasone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C0026764
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0011777
participant has had radiation therapy within 14 days of randomization
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
participant has known chronic obstructive pulmonary disease (copd) (defined as a forced expiratory volume in 1 second [fev1] <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). participants with known or suspected copd or asthma must have a fev1 test during screening
Beschreibung

COPD | FEV1 | Persistent asthma | H/O: asthma | Intermittent asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0748133
UMLS CUI [3]
C3266628
UMLS CUI [4]
C0455544
UMLS CUI [5]
C1740754
participant is known to be seropositive for history of human immunodeficiency virus (hiv) or known to have active hepatitis b or hepatitis c
Beschreibung

HIV Seropositivity | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT02252172

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Measurable Disease | Plasma Cells monoclonal Bone Marrow | Plasmacytoma Biopsy Proven | IgG myeloma | Monoclonal Protein Measurement | Multiple Myeloma-IgA | Multiple Myeloma-IgM | Multiple Myeloma-IgD | Multiple Myeloma-IgE | Multiple Myeloma-Light Chain Only | Serum Free Immunoglobulin Light Chain | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
participant must have documented multiple myeloma and measurable disease defined as: 1) monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma; 2) measurable disease as defined by any of the following: (a) immunoglobulin (ig) g myeloma (serum monoclonal paraprotein [m-protein] level >=1.0 gram/deciliter [g/dl] or urine m-protein level >=200 milligram[mg]/24 hours[hrs]; or (b) iga, igm, igd, or ige multiple myeloma (serum m-protein level >=0.5 g/dl or urine m-protein level >=200 mg/24 hrs); or (c) light chain multiple myeloma (serum immunoglobulin free light chain >=10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio)
boolean
C0026764 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0032112 (UMLS CUI [3,1])
C0746619 (UMLS CUI [3,2])
C0005953 (UMLS CUI [3,3])
C0032131 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0456369 (UMLS CUI [4,3])
C0563306 (UMLS CUI [5])
C2984963 (UMLS CUI [6])
C2347300 (UMLS CUI [7])
C2347304 (UMLS CUI [8])
C2347301 (UMLS CUI [9])
C2347302 (UMLS CUI [10])
C2347305 (UMLS CUI [11])
C2827352 (UMLS CUI [12])
C2826181 (UMLS CUI [13])
ECOG performance status
Item
participant must have an eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Newly Diagnosed | High-dose chemotherapy | Age | Co-morbid conditions | High-dose chemotherapy Consequence Negative | Stem cell transplant Consequence Negative
Item
participants who are newly diagnosed and not considered for high-dose chemotherapy due to: being age >=65 years; or participants less than (<) 65 years with presence of important comorbid condition(s) likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation. sponsor review and approval of participants below 65 years of age is required before randomization
boolean
C1518321 (UMLS CUI [1])
C1328050 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1275743 (UMLS CUI [4])
C1328050 (UMLS CUI [5,1])
C0686907 (UMLS CUI [5,2])
C0205160 (UMLS CUI [5,3])
C1504389 (UMLS CUI [6,1])
C0686907 (UMLS CUI [6,2])
C0205160 (UMLS CUI [6,3])
Childbearing Potential | Sexual Abstinence | Contraceptive methods
Item
women of childbearing potential must commit to either abstain continuously from sexual intercourse or to use 2 methods of reliable birth control simultaneously as deemed appropriate by the investigator. contraception must begin 4 weeks prior to dosing
boolean
C3831118 (UMLS CUI [1])
C0036899 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Males Sexually active | Childbearing Potential | Vasectomy | Contraceptive methods | Sperm donation | Lenalidomide | Daratumumab
Item
man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must also agree to not donate sperm during the study and for 4 weeks after last dose of lenalidomide and 4 months after last dose of daratumumab
boolean
C0086582 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2])
C0042387 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0871414 (UMLS CUI [5])
C1144149 (UMLS CUI [6])
C2346801 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Primary amyloidosis | Monoclonal Gammapathies | Monoclonal Protein Measurement | Lytic lesion Absent | Anemia | Hypercalcemia | Renal Insufficiency Due to M Protein | Smoldering myeloma | Asymptomatic multiple myeloma
Item
participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (presence of serum m-protein <3 g/dl; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the m-protein), or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organ or tissue impairment end organ damage)
boolean
C0268381 (UMLS CUI [1])
C1136085 (UMLS CUI [2])
C2984963 (UMLS CUI [3])
C0221204 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0002871 (UMLS CUI [5])
C0020437 (UMLS CUI [6])
C1565489 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0700271 (UMLS CUI [7,3])
C1531608 (UMLS CUI [8])
C2585107 (UMLS CUI [9])
Waldenstrom's disease | Medical condition IgM M Protein Present | Plasma cell infiltration Clonal | Lytic lesion
Item
participant has a diagnosis of waldenström's disease, or other conditions in which igm m protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
boolean
C0599055 (UMLS CUI [1])
C1699700 (UMLS CUI [2,1])
C0020861 (UMLS CUI [2,2])
C0700271 (UMLS CUI [2,3])
C0150312 (UMLS CUI [2,4])
C0391861 (UMLS CUI [3,1])
C1522642 (UMLS CUI [3,2])
C0221204 (UMLS CUI [4])
Malignant Neoplasms | Multiple Myeloma | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
participant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)
boolean
C0006826 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0007117 (UMLS CUI [4])
C0851140 (UMLS CUI [5])
systemic therapy Multiple Myeloma | Stem cell transplant Multiple Myeloma | Adrenal Cortex Hormones | Dexamethasone
Item
participant has prior or current systemic therapy or sct for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
boolean
C1515119 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0011777 (UMLS CUI [4])
Therapeutic radiology procedure
Item
participant has had radiation therapy within 14 days of randomization
boolean
C1522449 (UMLS CUI [1])
COPD | FEV1 | Persistent asthma | H/O: asthma | Intermittent asthma
Item
participant has known chronic obstructive pulmonary disease (copd) (defined as a forced expiratory volume in 1 second [fev1] <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). participants with known or suspected copd or asthma must have a fev1 test during screening
boolean
C0024117 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C3266628 (UMLS CUI [3])
C0455544 (UMLS CUI [4])
C1740754 (UMLS CUI [5])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
participant is known to be seropositive for history of human immunodeficiency virus (hiv) or known to have active hepatitis b or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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