A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Open to people ages 18-79

• Have newly diagnosed multiple myeloma with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT): (a) for participants who have not received consolidation therapy, the participant must be 60 to 100 days post-transplant at the time of randomization; and (b) for participants treated with consolidation therapy, the participant must be within 60 days of the last dose of consolidation therapy at the time of randomization
• Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
• Have archived bone marrow biopsy samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction). Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by next generation sequencing (NGS). Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of −80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow tissue for minimal residual disease (MRD) assessment: (i) 5 slides, 5 micrometer each, of non-decalcified bone marrow, or (ii) 5 slides, 5 micrometer each, bone marrow aspirate smear
• Must have residual disease as defined by detectable MRD by next generation flow (NGF) assay
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2