Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical a
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.
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 patients who have a contraindication or who are unable to have MRI performed.) * Involved/uninvolved light chain ratio \<100 (unless involved light chain is ≤10 mg/dL) NOTE: Anemia, renal failure, and hypercalcemia is |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Carl Ola Landgren, MD, PhD |
| Locations | Miami, Florida, United States |
| Start date | 2023-12-04 |
| NCT ID | NCT06100237 |
| Official listing | https://clinicaltrials.gov/study/NCT06100237 |