Clinical Research Directory

Inclusion Criteria: * 18 to 70 years of age, inclusive. * Must have a new diagnosis of MM as per IMWG criteria. * Measurable disease * Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Clinical laboratory values meeting the required criteria during screening and ≤3 days prior to receiving first study treatment dose. * Adequate bone marrow function. * Adequate liver function. * Adequate renal function. * A female of childbearing potential (FOCBP) must have two negative serum or urine pregnancy tests at screening including within 24 hours of the start of study treatment. * Willing to practicing at least 1 highly effective method of contraception starting 4 weeks prior to start of study treatment, while receiving study treatment including during any dose interruptions, and for at least 3 months after the last dose of any component of the study treatment. Exclusion Criteria: * Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. * History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy. * 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 5. * Myelodysplastic syndrome or any malignancy within 24 months of signing consent. The only exceptions are malignancies treated within the last 24 months that are considered completely cured. * Plasmapheresis ≤28 days of approval. * Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment. * Forced Expiratory Volume in 1 second (FEV1) \<50% of predicted normal. * Concurrent medical or psychiatric condition or disease. * Myocardial infarction ≤6 months of enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function. * Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities. * Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or the excipients of daratumumab, lenalidomide, bortezomib or dexamethasone. * Pregnant or breast-feeding females