Teclistamab or Talquetamab in Combination With Daratumumab SC for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Sequential Cohort Immuno-Oncology Study to REVIVE Early Myeloma
Carl Ola Landgren, MD, PhD
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10 including: * Serum M-protein ≥3 g/dL and/or BMPCs≥10 % (but \<60%) * Absence of anemia: hemoglobin \>10 g/dL * Absence of renal failure: serum creatinine \<2.0 mg/dL * Absence of hypercalcemia: Calcium \<10.5 mg/dL * Absence of lytic bone lesion on X-ray, CT, or positron emission tomography (PET)/CT and not more than 1 lesion on whole body MRI (NOTE: At the discretion of the Investigator, whole body CT or PET/CT may replace MRI in p…
Interventions
- DrugTeclistamab
Teclistamab will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
- DrugTalquetamab
Talquetamab will be administered per discretion of treating physician. Participants will receive the recommended dosage.
- DrugDaratumumab SC
Daratumumab SC will be administered by subcutaneous (SC) injection per discretion of treating physician. Participants will receive the recommended dosage.
Location
- University of MiamiMiami, Florida