RecruitingPhase 2NCT06461988

Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)


Sponsor

Stanford University

Enrollment

20 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether using talquetamab (a bispecific antibody targeting myeloma cells) combined with lenalidomide as maintenance therapy after a stem cell transplant can keep multiple myeloma in deep remission for longer. **You may be eligible if...** - You have been diagnosed with multiple myeloma and confirmed by standard diagnostic criteria - Your myeloma showed measurable disease at the time of original diagnosis - You have completed induction therapy and had a stem cell transplant, and are in remission - You are not currently relapsed or refractory **You may NOT be eligible if...** - You cannot tolerate lenalidomide at even a low dose (10 mg or 5 mg) - Your myeloma has relapsed or been refractory at any point before enrollment - You have previously received GPRC5D-directed therapy or T-cell redirection therapy (e.g., bispecific antibodies or CAR-T targeting myeloma) - You have serious allergies to the study drugs 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

DRUGTalquetamab

Talquetamab Step up dosing: C1D1: 10 mcg/kg C1D3: 60 mcg/kg C1D5: 400 mcg/kg C1D15: 800 mcg/kg Talquetamab 800 mg/kg SC Q4W in 28-day cycle for Cycles 2-13

DRUGTalquetamab and Lenalidomide

Lenalidomide 10 mg, 3 weeks on 1 week off, until PD/ intolerance, C2-13 (Lenalidomide 5 mg for creatinine clearance 30-60 ml/min)


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06461988


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