OncoMatch/Clinical Trials/NCT06993675
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Is NCT06993675 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Talquetamab and Teclistamab for multiple myeloma.
Treatment: Talquetamab · Teclistamab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD38 antibody-based induction — induction
completed at least four cycles of quadruplet, anti-CD38 antibody-based induction
Must have received: autologous stem cell transplant — post-induction
have received HDM ASCT within 60-120 days
Cannot have received: targeted therapy
Targeted therapy ... within 21 days or ≥5 half-lives, whichever is less
Cannot have received: epigenetic therapy
epigenetic therapy ... within 21 days or ≥5 half-lives, whichever is less
Cannot have received: investigational drug or invasive investigational medical device
treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Cannot have received: investigational vaccine
Investigational vaccine within four weeks
Cannot have received: monoclonal antibody therapy
Monoclonal antibody therapy within 21 days
Cannot have received: cytotoxic chemotherapy
Cytotoxic therapy within 14 days
Cannot have received: proteasome inhibitor
PI therapy within 14 days
Cannot have received: IMiD agent
IMiD agent therapy within 14 days
Cannot have received: radiation therapy
Radiotherapy within 14 days or focal radiation within seven days
Cannot have received: gene-modified adoptive cell therapy (CAR-T cell therapy, NK cell therapy)
Gene-modified adoptive cell therapy (e.g., chimeric antigen receptor modified T-cells, NK cells) within three months
Cannot have received: bispecific T-cell engager
Prior exposure to a bispecific T-cell engager or CAR T-cell therapy
Cannot have received: CAR-T cell therapy
Prior exposure to a bispecific T-cell engager or CAR T-cell therapy
Lab requirements
Blood counts
Hemoglobin ≥8 g/dL (no transfusion within 7 days); ANC ≥1.0×10^9/L (no G-CSF/GM-CSF within 7 days, no peg-GCSF within 14 days); Platelets ≥75×10^9/L (no transfusion or TPO agonist within 7 days)
Kidney function
Estimated creatinine clearance ≥30 mL/min (Cockcroft-Gault Equation)
Liver function
AST ≤2.5x ULN; ALT ≤2.5x ULN; serum bilirubin ≤1.5x ULN (except Gilbert syndrome <5x ULN)
Adequate bone marrow function: Hemoglobin 8 g/dl (³5mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted). Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF). Platelets ³75×109/L (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test). Estimated creatinine clearance ≥30 mL/min based on the Cockcroft-Gault Equation. Aspartate aminotransferase ≤2.5 folds of the upper limit of normal (ULN). Alanine aminotransferase ≤2.5 folds of the ULN. Serum bilirubin ≤ 1.5 x ULN (except in participants with congenital bilirubinemia, such as Gilbert syndrome where must be <5xULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
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