Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
- Registration Number
- NCT06993675
- Lead Sponsor
- Noffar Bar
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Talquetamab Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Arm 1 Teclistamab Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.
- Primary Outcome Measures
Name Time Method Efficacy of Increasing the Rate of Minimal Residual Disease Negativity in Patients Who Have Been Newly Diagnosed with Multiple Myeloma At baseline then at Cycle 7, each cycle is 28 days The primary objective of this study is to assess the efficacy of using talquetamab as a consolidation treatment, either alone or followed by teclistamab, in increasing the rate of minimal residual disease (MRD) negativity in patients who have been newly diagnosed with multiple myeloma. By conducting a thorough evaluation, the study aims to determine the potential benefits of these treatment protocols in achieving deeper levels of disease response and remission.
- Secondary Outcome Measures
Name Time Method Complete Response and MRD-Negative Complete Response in Multiple Myeloma Patients Treated with Talquetamab Consolidation, With or Without Sequential Teclistamab At baseline then at Cycle 7, each cycle is 28 days To evaluate the achievement of complete response (CR) or better, including MRD-negative complete response, in patients with multiple myeloma who are treated with talquetamab as a consolidation therapy. The assessment will include both scenarios: talquetamab used alone and talquetamab followed by sequential teclistamab. This evaluation aims to provide insights into the depth of response and eradication of minimal residual disease in the treated cohorts.
Assessment of Minimal Residual Disease (MRD) at 10^-6 Sensitivity in Multiple Myeloma Patients At baseline then at Cycle 7, each cycle is 28 days To assess the level of minimal residual disease (MRD) at a sensitivity threshold of 10\^-6 in patients with multiple myeloma undergoing treatment. This high sensitivity assessment aims to determine the extent of disease eradication and to provide a deeper understanding of the effectiveness of the therapeutic regimen in achieving nearly undetectable levels of remaining cancer cells.
Determination of Sustained MRD-Negative Rate at One Year in Multiple Myeloma Patients One year post-treatment To determine the sustained minimal residual disease (MRD) negative rate one year post-treatment in patients with multiple myeloma. This measure aims to evaluate the durability of the MRD-negative status over a one-year period, providing insights into the long-term efficacy of the treatment regimen in maintaining deep and persistent disease remission.
Quality of Life Assessment via Patient-Reported Outcomes in Response to Treatment Day 1 of Cycles 1-6, where each cycle is 28 days, then at EOT(treatment durations is 15-24 months) and Safety Follow-Up visits(patients will be followed for 6 months) To evaluate the quality of life (QoL) of patients with multiple myeloma through patient-reported outcome measures in response to the treatment regimen. This assessment aims to capture the subjective experiences of patients, including physical, emotional, and social well-being, to gain a comprehensive understanding of how the treatment impacts their overall quality of life. Patient-reported outcomes will provide valuable insights into the effectiveness of the therapy from the perspective of those undergoing treatment.
Assessment of Treatment-Related Adverse Events in Multiple Myeloma Patients From baseline till the first safety follow-up visit; approximately 15-24 months To assess the incidence and severity of treatment-related adverse events in patients with multiple myeloma undergoing the specified therapeutic regimen. This evaluation aims to systematically document and analyze any negative side effects or complications associated with the treatment, providing crucial safety data and helping to weigh the risks against the potential benefits of the therapy.
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States