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])
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])