RecruitingPhase 2NCT06993675

Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

Improving MRD Negativity Rates in Newly Diagnosed Multiple Myeloma Patients: a Response-adaptive Approach of Consolidation With One or Two Bispecific T-cell Engagers Against GPRC5D or BCMA


Sponsor

Noffar Bar

Enrollment

50 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction with or without transplant have worse prognosis than those with MRD negative disease. Bispecific T-cell-based immunotherapies have the potential to promote further reduction of malignant plasma cells thus improving rates of MRD negativity and improve patient outcomes. In this study, participants who are MRD positive after front line therapy will receive consolidation with GPRC5D-targeted bispecific talquetamab. We will test MRD negative conversion and if MRD negativity was not achieved, the participant will switch to a different target using the B-cell maturation antigen TCE, teclistamab. Consolidation will be continued for up to 1 year in participants who have achieved MRD negativity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a T-cell engaging treatment strategy to eliminate minimal residual disease (tiny amounts of cancer remaining after stem cell transplant) in newly diagnosed multiple myeloma patients who still have detectable cancer cells despite initial treatment and transplant. **You may be eligible if...** - You are 18 or older - You were recently diagnosed with multiple myeloma, received at least 4 cycles of induction therapy with an anti-CD38 antibody-based regimen, and underwent a stem cell transplant within the last 60–120 days - Sensitive genetic testing (NGS) still detects cancer cells at a level of at least 1 in 100,000 - You had at least a partial response to treatment - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your multiple myeloma is progressing - You have very poor organ function or significant bone marrow failure 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 is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.

DRUGTeclistamab

Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.


Locations(2)

Yale University

New Haven, Connecticut, United States

Wilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical Center

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06993675


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