Clinical trial NCT02195479 (phase 3, status: active, not recruiting)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: velcade, melphalan, prednisone, daratumumab iv, dexamethasone, daratumumab sc
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have documented multiple myeloma satisfying the calcium elevation,
             renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria,
             monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or
             presence of a biopsy proven plasmacytoma, and measurable secretory disease, as
             assessed by the central laboratory, and defined in protocol

          -  Participants who are newly diagnosed and not considered candidate for high-dose
             chemotherapy with stem cell transplantation (SCT) due to: being age >=65 years, or in
             participants <65 years: presence of important comorbid conditions likely to have a
             negative impact on tolerability of high dose chemotherapy with stem cell
             transplantation

          -  Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
             score of 0, 1, or 2

          -  Meet the clinical laboratory criteria as specified in the protocol

          -  A woman of childbearing potential must have a negative serum pregnancy test at
             screening within 14 days prior to randomization

          -  Women of childbearing potential must commit to either abstain continuously from
             heterosexual sexual intercourse or to use 2 methods of reliable birth control
             simultaneously. This includes one highly effective form of contraception (tubal
             ligation, intrauterine device, hormonal [birth control pills, injections, hormonal
             patches, vaginal rings or implants] or partner's vasectomy) and one additional
             effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical
             cap). Contraception must begin prior to dosing. Reliable contraception is indicated
             even where there has been a history of infertility, unless due to hysterectomy or
             bilateral oophorectomy

        Exclusion Criteria:

          -  Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of
             undetermined significance, or smoldering multiple myeloma

          -  Participant has a diagnosis of Waldenstrom'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

          -  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 4 days) of corticosteroids before treatment

          -  Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as
             defined by the national cancer institute common terminology criteria for adverse
             events (NCI CTCAE) Version 4

          -  Participant has a history of malignancy (other than multiple myeloma) within 3 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 3 years)

          -  Participant has had radiation therapy within 14 days of randomization

          -  Participant has had plasmapheresis within 28 days of randomization

          -  Participant has known chronic obstructive pulmonary disease (COPD) (defined as a
             forced expiratory volume in 1 second [FEV1] <50% of predicted normal), known moderate
             or severe persistent asthma within the last 2 years or currently has uncontrolled
             asthma of any classification (controlled intermittent asthma or controlled mild
             persistent asthma is allowed)

          -  Participants with known or suspected COPD must have a FEV1 test during screening

          -  Participant is known to be seropositive for human immunodeficiency virus (HIV), known
             to have hepatitis B surface antigen positivity, or history of to have a history of
             hepatitis C

          -  Participant has any concurrent medical or psychiatric condition or disease (example
             active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary
             disease) that is likely to interfere with the study procedures or results, or that in
             the opinion of the investigator, would constitute a hazard for participating in this
             study