Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

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 s

Trial Details

NCT ID
NCT05469893
Phase
PHASE2
Sponsor
Irene Ghobrial, MD
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Teclistamab
  • Lenalidomide
  • Dexamethasone
Locations (sample)
  • Denver, Colorado, United States|39.73915,-104.9847
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Portland, Oregon, United States|45.52345,-122.67621

Key Eligibility 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:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Multiple Myeloma Trials on Trialify →