Trial · NCT06993675
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
NCT06993675, Phase 2, Recruiting, Noffar Bar
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE). Trials, record NCT06993675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06993675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
- NCT number
- NCT06993675
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Noffar Bar
- Conditions
- Multiple Myeloma
- Interventions
- Talquetamab, Teclistamab
- First posted
- 2025-05-29
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 Months | 12 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06993675
GET https://conductscience.org/api/trials/v1/NCT06993675/registered