RecruitingPhase 2

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

United States52 participantsStarted 2022-08-10

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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(14,16), 1q gain, or del13q = 2 * 2\) Presence of ≥10% BMPC and at least one of the following: \-- Evolving pattern: * evolving Monoclonal Protein (eMP) (≥10% increase in Monoclonal Protein/Immunoglobulin (Ig)) within the first 6 months (only if M-protein ≥3 g/dl) and/or ≥25% increase in M/Ig within the first 12 months, with a minimum required increase of 0.5 g/dl in M-protein and/or 500 mg/dl in Ig. * Evolving change in hemoglobin (eHb) ≥0.5 g/dl decrease within 12 months of diagnosis; * Progressive involved light chain increase on two successive evaluation * Abnormal Plasma Cell immunophenotype (≥ 95% of BMPCs are clonal) and reduction of ≥1 uninvolved immunoglobulin isotype. (Only IgG; IgA and IgM will be considered) * High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain * Monoclonal light chain excretion of \>…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Response Rate (CRR)

Timeframe: Cycle 2 Day 1 through end of follow up (each cycle is 28 days).

Trial details

NCT IDNCT05469893

SponsorIrene Ghobrial, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07-31

Contact for this trial

Irene Ghobrial, MD

617-632-4198 Irene_ghobrial@dfci.harvard.edu

View on ClinicalTrials.gov More High-risk Smoldering Multiple Myeloma trials