The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will:
1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-. 2. Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status. 3. Increase the length of time that participants' disease responds to treatment.
The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) documented initially prior to any treatment (Kumar et al., 2016).
Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38).
Documentation of receiving induction therapy with or without high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and receiving lenalidomide maintenance therapy ≤ 12 months.
Cohort 1: at the time of assessment, the patient's current response is a partial response (PR), very good partial response (VGPR), or complete response (CR) but MRD+ by the FDA-cleared next-generation sequencing (NGS) Adaptive clonoseq assay.
Patients who have received prior systemic therapies for Multiple Myeloma (MM) other than initial IMiD/PI/anti CD38/HDM-ASCT-based combination therapy.
Treatment with corticosteroids for MM or other indications is permitted.
Prior radiation therapy and surgery is permitted.
Patients who are receiving any other investigational agents unless deemed not to interfere with the study by the Principal Investigator (PI).
Dickran Kazandjian, MD
Lead sponsor
University of Miami
Sponsor institution
Regeneron Pharmaceuticals
Collaborator