OncoMatch/Clinical Trials/NCT06100237
Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
Is NCT06100237 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Teclistamab and Talquetamab for multiple myeloma.
Treatment: Teclistamab · Talquetamab · Daratumumab SC — The purpose of this study is to see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: IGH t(4;14)
Chromosomal abnormalities specifically translocation of chromosomes 4 or 14 (t(4;14))
Allowed: TP53 deletion of the short arm of chromosome 17 (del(17p))
deletion of the short arm of chromosome 17 (del(17p))
Allowed: CKS1B gain of the long arm of chromosome 1 (1q gain)
gain of the long arm of chromosome 1 (1q gain) found in ≥5% of cells
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: One prior cycle (4-5 weeks) of therapy for SMM is allowed provided that patient undergoes a 4-week washout period prior to first dose of study treatment. Treatment with corticosteroids for other indications is permitted.
Patients who have received prior systemic therapies for SMM/MM. One prior cycle (4-5 weeks) of therapy for SMM is allowed provided that patient undergoes a 4-week washout period prior to first dose of study treatment. Treatment with corticosteroids for other indications is permitted.
Lab requirements
Blood counts
ANC >1.0 K cells/μL (0.5-1.0 K/μL allowed if chronic/ethnic neutropenia and no complications); Platelet count >75 K cells/μL; Hemoglobin >8 g/dL (transfusions permissible if anemia not due to myeloma)
Kidney function
serum creatinine <2.0 mg/dL; ≥30 mL/min based on MDRD or CrCl measured by 24-hour urine collection; eGFR by Cockcroft-Gault or CKD-EPI per institutional standards
Liver function
Total bilirubin <1.5 X ULN (isolated total bilirubin ≥1.5 X ULN with conjugated [direct] bilirubin <1.5 X ULN is allowed for those with Gilbert's syndrome); AST/ALT ≤2.5 X ULN
Patients must have adequate organ and marrow function ≤45 days as defined below: ANC >1.0 K cells/μL... Platelet count >75 K cells/μL... Hemoglobin >8 g/dL... Total bilirubin <1.5 X ULN... AST/ALT ≤2.5 X ULN... ≥30 mL/min based on MDRD or CrCl measured by 24-hour urine collection...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06100237 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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