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ID

15516

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02252172

Keywords

versioni (1)
  1. 02/06/16 02/06/16 -
Caricato su

2 giugno 2016

DOI

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Licenza

Creative Commons BY 4.0
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    Eligibility Multiple Myeloma DRKS00007830 NCT02252172

    Inglese

    Eligibility Multiple Myeloma NCT02252172

    1 moduli  
    Inclusion Criteria
    Descrizione

    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)
    Descrizione

    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

    Tipo di dati

    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
    Descrizione

    ECOG performance status

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    Childbearing Potential | Sexual Abstinence | Contraceptive methods

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    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)
    Descrizione

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

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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)
    Descrizione

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

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    Therapeutic radiology procedure

    Tipo di dati

    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
    Descrizione

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

    Tipo di dati

    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
    Descrizione

    HIV Seropositivity | Hepatitis B | Hepatitis C

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
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    Similar models

    Eligibility Multiple Myeloma NCT02252172

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    Ritorna all'inizio della pagina 

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