Actively Recruiting
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Led by Irene Ghobrial, MD · Updated on 2025-04-24
52
Participants Needed
3
Research Sites
416 weeks
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
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)
CONDITIONS
Official Title
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- High-risk smoldering multiple myeloma defined by specific criteria including serum M spike, free light chain ratio, bone marrow plasma cell percentage, or a scoring system
- Presence of at least 10% bone marrow plasma cells and at least one evolving pattern or high-risk cytogenetics
- No evidence of CRAB criteria or new active multiple myeloma criteria
- ECOG Performance Status of 0, 1, or 2
- Adequate laboratory values for blood counts, liver function, and kidney function within 28 days prior to registration
- Voluntary written informed consent
- Females of child-bearing potential randomized to Lenalidomide must have negative pregnancy tests and use effective contraception
- Male participants must use condoms and agree to not donate sperm during and 90 days after treatment
- Must be willing and able to follow lifestyle restrictions and REMS program requirements if randomized to Lenalidomide
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior smoldering multiple myeloma therapy within 6 months before study treatment
- Symptomatic multiple myeloma or presence of CRAB criteria or prior therapy for active myeloma
- Concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy (with exceptions for bisphosphonates and prior radiation over 6 months ago)
- Serious medical or psychiatric conditions interfering with participation
- Diagnosis or treatment for another cancer within 2 years
- Uncontrolled infections or illnesses such as heart failure, unstable angina, arrhythmias, or psychiatric illness limiting compliance
- Plans to father a child or pregnancy/breastfeeding during study and 90 days after last dose
- Active viral infections including HIV, hepatitis B or C, or active COVID-19 infection
- Allergies or contraindications to study drugs
- Recent exposure to vaccines, monoclonal antibodies, cytotoxic or immunomodulatory therapies, or radiotherapy within specified time frames
- Active central nervous system involvement of multiple myeloma
- Myelodysplastic syndrome or active malignancies except certain cured or low-risk cancers
- Recent stroke or seizure within 6 months
- Certain cardiac conditions such as severe heart failure or recent myocardial infarction
- Major surgery within 2 weeks before or planned during study treatment
- Any condition that would interfere with study procedures or safety as judged by the investigator
AI-Screening
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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
CONTACT
A
Ashlee Sturtevant, MSc
CONTACT
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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