Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Trial Parameters
Brief Summary
The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron)
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * 1\) High risk SMM defined as having 1 of the following 2 criteria: High risk per "20-2-20" Criteria defined as presence of any two of the following: \-- Serum M spike ≥ 2 gm/dL, Involved to uninvolved free light chain (FLC) ratio≥ 20, Bone marrow Plasma Cell (BMPC) % ≥ 20% * OR total score of 9 using the following scoring system: * FLC Ratio \>10-25 = 2, \>25-40 = 3, \> 40 = 5 * Serum M-Protein (g/dL) \>1.5-3 = 3, \>3 = 4 * BMPC% \>15-20 = 2, \>20-30 = 3, \>30-40 = 5, \>40 = 6 * Fluorescence In Situ Hybridization (FISH) abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2 * 2\) Presence of ≥10% BMPC and at least one of the following: \-- Evolving pattern: * evolving Monoclonal Protein (eMP) (≥10% increase in Monoclonal Protein/Immunoglobulin (Ig)) within the first 6 months (only if M-protein ≥3 g/dl) and/or ≥25% increase in M/Ig within the first 12 months, with a minimum required increase of 0.5 g/dl in M-protein and/or 500 mg/dl in Ig. * Evolvi