Actively Recruiting
Immuno-PRISM (PRecision Intervention Smoldering Myeloma): A Randomized Phase II Platform Study of Select Immunotherapies for High-Risk Smoldering Myeloma
Led by Irene Ghobrial, MD · Updated on 2025-04-24
52
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Irene Ghobrial, MD
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-cancer activity of Teclistamab compared to the combination of Lenalidomide and Dexamethasone in people with high-risk smoldering multiple myeloma, a condition where plasma cells in the immune system show early cancer signs but without symptoms. This phase II randomized study aims to find effective immunotherapies for this condition, which currently has no approved treatments, and to establish the safety of Teclistamab in this population. The study involves multiple arms with participants randomly assigned to receive either Teclistamab or the combination of Lenalidomide and Dexamethasone. Initially, a safety run-in phase will enroll up to six participants to monitor Teclistamab safety at different doses. After confirming safety, participants will be randomized in a 1:2 ratio to the control arm (Lenalidomide + Dexamethasone) or the investigational Teclistamab arm. Each treatment cycle lasts 28 days, and treatment continues for up to 24 months or until disease benefits cease. Participants will undergo screening, treatment, end of treatment, and follow-up phases. Researchers will assess response rates, disease progression, and various biomarkers through scheduled visits, blood tests, imaging, and laboratory studies over several years. Safety will be closely monitored, including adverse events and survival outcomes. The trial plans to enroll about 51 participants and follow them for up to five years to evaluate long-term outcomes and treatment effects.
CONDITIONS
Brief Title
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with high-risk smoldering multiple myeloma defined by specific blood and bone marrow criteria
- No symptoms or signs of active multiple myeloma including CRAB criteria
- ECOG performance status of 0, 1, or 2
- Adequate blood counts and organ function within 28 days before enrollment
- Willingness to provide informed consent
- Females of child-bearing potential must meet pregnancy testing and contraception requirements if randomized to Lenalidomide
- Men must agree to use condoms and not donate sperm during and for 90 days after treatment
- Must be willing to follow study lifestyle restrictions and Revlimid REMS program if applicable
You will not qualify if you...
- Prior smoldering multiple myeloma therapy within 6 months before study start
- Active multiple myeloma or any prior therapy for active myeloma
- Concurrent investigational treatments or therapies
- Serious medical or psychiatric conditions affecting participation
- Recent or active other cancers within 2 years, with some exceptions
- Uncontrolled infections or illnesses including HIV, hepatitis, or COVID-19
- Known allergies to study drugs
- Recent use of vaccines, monoclonal antibodies, chemotherapy, or radiation therapy within specified timeframes
- Active central nervous system involvement
- Major surgery within 2 weeks before treatment or planned during treatment
- Medical or psychiatric conditions interfering with study or consent capability
- History of non-compliance with medical treatments
- Pregnancy or breastfeeding or plans to become pregnant during study or within 90 days after treatment end
- Plans to father a child during study or within 90 days after treatment end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive study treatment with either Teclistamab or a combination of Lenalidomide and Dexamethasone. Treatment cycles last 28 days and continue as long as there is disease benefit or up to 24 months.
Monthly visits for treatment cycles
Duration - Up to 3 years after treatment
Participants are monitored for disease progression, survival, and long-term effects for up to 3 years after treatment ends.
Visits every 6 months during follow-up
Trial Site Locations
Total: 3 locations
1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
I
Irene Ghobrial, MD
A
Ashlee Sturtevant, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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