Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma
Irene Ghobrial, MD
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)
Description
This is a multiple arm, randomized, phase II platform study investigating the efficacy of Teclistamab or other immunotherapies against a control arm of Lenalidomide + Dexamethasone combination in participants with high-risk smoldering multiple myeloma. The names of the study drugs involved in this study are: * Teclistamab * Lenalidomide (also called Revlimid) * Dexamethasone (also called Decadron) Safety of Teclistamab in SMM population will be established by using safety run-in method in the beginning of the study and will enroll up to 6 participants directly into Teclistamab arm. First 3…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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(…
Interventions
- DrugTeclistamab
Intravenous (IV) dosage and timing per protocol design
- DrugLenalidomide
Oral, dosage and timing per protocol design
- DrugDexamethasone
Oral, dosage and timing per protocol design
Locations (3)
- Colorado Blood Cancer InstituteDenver, Colorado
- Dana Farber Cancer InstituteBoston, Massachusetts
- Oregon Health & Science UniversityPortland, Oregon