OncoMatch/Clinical Trials/NCT05469893
Immuno-PRISM (PRecision Intervention Smoldering Myeloma)
Is NCT05469893 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Teclistamab and Lenalidomide for high-risk smoldering multiple myeloma.
Treatment: Teclistamab · Lenalidomide · Dexamethasone — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: IGH t(4;14)
FISH abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2
Allowed: IGH t(14;16)
FISH abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2
Allowed: IGH t(14;20)
High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain
Allowed: TP53 mutation
High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain
Allowed: TP53 deletion
High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain
Allowed: 1Q21 gain
High risk cytogenetics defined as presence of t(4;14), t(14;16), t(14;20), 17p deletion, TP53 mutation, 1q21 gain
Allowed: 13Q deletion
FISH abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: SMM directed therapy
Exception: allowed if administered >6 months before beginning treatment on study; prior lenalidomide-based therapy requires at least Minimal Response (MR)
Prior SMM directed therapy administered within 6 months of beginning treatment on study. To avoid including primary refractory cases to the lenalidomide arm, participants who received a prior lenalidomide-based therapy should have had at least an Minimal Response (MR) to be considered on this trial.
Cannot have received: therapy for active Multiple Myeloma
Any prior therapy for active Myeloma should also be excluded. Prior therapy for smoldering myeloma is not an exclusion criterion.
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) >1000/mL; Platelets Count (PLT) >75,000/mL
Kidney function
Estimated creatinine clearance (CLcr) ≥60 mL/min
Liver function
Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.); AST <2.5 x institutional ULN; ALT <2.5 x institutional ULN
The following laboratory values obtained <28 days prior to registration: ANC >1000/mL; PLT >75,000/mL; Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.); AST <2.5 x institutional ULN; ALT <2.5 x institutional ULN; Estimated creatinine clearance (CLcr) ≥60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Colorado Blood Cancer Institute · Denver, Colorado
- Dana Farber Cancer Institute · Boston, Massachusetts
- Oregon Health & Science University · Portland, Oregon
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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