RecruitingPhase 2NCT05469893

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma

Sponsor

Irene Ghobrial, MD

Enrollment

52 participants

Start Date

Aug 10, 2022

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing precision immunotherapy approaches for people with smoldering myeloma — an early, "pre-cancer" form of multiple myeloma (a blood cancer) — to prevent it from progressing to full multiple myeloma. **You may be eligible if...** - You have been diagnosed with smoldering multiple myeloma (an early stage with no symptoms yet) - Your condition meets specific criteria suggesting a higher risk of progressing to active myeloma - You have not yet required treatment for active myeloma **You may NOT be eligible if...** - You already have active (symptomatic) multiple myeloma requiring treatment - You have severe organ damage from the disease - You have a serious active infection or immune deficiency - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Institute

Denver, Colorado, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Oregon Health & Science University

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT05469893