ROTATE Study: Talquetamab and Teclistamab for Multiple Myeloma
This study is for people with newly diagnosed multiple myeloma (a type of blood cancer) who still have minimal residual disease (MRD) after their initial treatment. MRD means a very small number of cancer cells remain. The study aims to see if using two specific drugs, talquetamab and then possibly teclistamab, can eliminate these remaining cancer cells. Both drugs are 'bispecific antibodies,' meaning they help your body's T-cells (a type of immune cell) find and kill cancer cells. The main goal is to measure how many participants become MRD-negative (meaning no cancer cells are detected) within 12 months. About 50 people are expected to join, and you must be 18 or older to participate. The study status is currently unclear.
- Study design
- This is an interventional study involving about 50 participants. It tests the use of talquetamab, followed by teclistamab if MRD negativity is not achieved.
- What's involved
- You would need to agree to all study procedures and be available for the study's duration. The primary endpoint is measured at 12 months from the start of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 12 months from the start of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Noffar Bar, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Rate of MRD Negative Response at 10^-5 Sensitivity Using NGS ClonoSEQ Assay in Participants with Newly Diagnosed Multiple Myeloma Treated with Talquetamab Consolidation With or Without Sequential Teclistamab by 12 Months12 months from the start of treatment
The primary outcome measure will evaluate the efficacy of talquetamab consolidation therapy, with or without the sequential use of teclistamab, by assessing the rate of minimal residual disease (MRD) negative response at a sensitivity level of 10\^-5. This evaluation will be conducted using the next-generation sequencing (NGS) ClonoSEQ assay. The primary endpoint is the proportion of participants who achieve MRD negativity at 10\^-5 sensitivity after consolidation therapy with talquetamab, with or without the sequential use of teclistamab, by 12 months from the start of treatment. MRD negative response is defined as the absence of detectable myeloma cells in bone marrow, as determined by the highly sensitive NGS ClonoSEQ assay. This measure aims to determine the depth of response and the potential of the treatment regimen to achieve sustained deep remission in participants with newly diagnosed multiple myeloma.