Actively Recruiting
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Led by Noffar Bar · Updated on 2026-05-13
50
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
Sponsors
N
Noffar Bar
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 and 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. After consolidation therapy on this protocol is complete, participants may continue to be treated with standardof- care (SOC) maintenance therapy.
CONDITIONS
Official Title
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with study procedures and available for the study duration.
- Male or female aged 18 years or older.
- Newly diagnosed multiple myeloma patients who are transplant eligible, completed at least four cycles of anti-CD38 antibody-based induction, and had high-dose melphalan autologous stem cell transplant within 60-120 days.
- MRD positive disease at 10^-5 sensitivity based on next-generation sequencing with a partial response or better.
- No disease progression as per International Myeloma Working Group criteria.
- ECOG performance status of 0 or 1; ECOG 2 or 3 allowed if related to stable physical limitations not from multiple myeloma.
- Adequate bone marrow function: Hemoglobin ≥8 g/dL without recent transfusion, neutrophils ≥1.0 x10^9/L without recent growth factor support, platelets ≥75 x10^9/L without recent transfusion or thrombopoietin receptor agonist.
- Estimated creatinine clearance ≥30 mL/min.
- Adequate liver function with AST and ALT ≤2.5 times upper limit of normal, bilirubin ≤1.5 times upper limit of normal (exceptions for congenital bilirubinemia).
- Adherence to reproductive and contraceptive requirements during and after treatment, including negative pregnancy tests and use of highly effective contraception methods for participants of childbearing potential and their partners.
You will not qualify if you...
- Prior or recent exposure to targeted therapy, epigenetic therapy, investigational drugs or devices within specified washout periods.
- Active or suspected infection at screening.
- Known HIV infection.
- History or evidence of hepatitis B or C infection unless adequately treated and controlled.
- Class III or IV congestive heart failure.
- Clinically relevant central nervous system pathology.
- Other active malignancies requiring treatment except certain treated and cured cancers.
- Pregnancy or lactation.
- Allergic reactions to talquetamab or teclistamab components.
- Recent corticosteroid use exceeding specified dose.
- Recent live vaccine administration.
- Plasma cell leukemia, smoldering myeloma, Waldenström's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis.
- Recent stroke, transient ischemic attack, seizure, or significant cardiac events.
- Major surgery within two weeks before treatment start or planned during the study without full recovery.
- Medical or psychiatric conditions likely to interfere with study or participant safety, including active infections, autoimmune diseases requiring immunosuppressive therapy, severe psychiatric disorders, or noncompliance history.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Wilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
Research Team
C
Carole Ramm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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