Improving MRD Negativity Rates in Newly Diagnosed Multiple Myeloma Patients: a Response-adaptive Approach of Consolidation With One or Two Bispecific T-cell Engagers Against GPRC5D or BCMA
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: II
Principal Investigator: Holstein, Sarah
Contact Information:
Kellee Halliburton
khalliburton@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06993675?term=NCT06993675&viewType=Card&rank=1#participation-criteria
Summary
Primary Objective
1. To evaluate the efficacy of talquetamab consolidation, with or without sequential use of teclistamab, as assessed by the MRD negative response rate for participants with newly diagnosed multiple myeloma.
Secondary objectives
1. To determine the complete response (CR) or better and MRD negative CR of participants with multiple myeloma treated with talquetamab, with or without sequential teclistamab in consolidation.
2. To assess MRD at a level of 10-6.
3. To determine sustained MRD negative rate at one year.
4. To assess quality of life (QOL) metrics through patient reported outcomes in response to treatment.
5. To assess treatment-related adverse events.