- Active, not recruiting
NCT03012880: Phase 2 - Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab NDMM
Updated: Apr 24, 2022
NCT03012880: Phase 2 - Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab may work better in treating patients with newly diagnosed multiple myeloma.
Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03012880
Official Title: Phase 2 Trial of Ixazomib, Lenalidomide, Dexamethasone, and Daratumumab in Patients With Newly Diagnosed Multiple Myeloma
Drug: Lenalidomide
Biological: Daratumumab
Drug: Dexamethasone
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
3196 Daratumumab, Ixazomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
Program: Oral and Poster Abstracts
Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster III
Hematology Disease Topics & Pathways:
Therapies, Combinations, Clinically relevant
Monday, December 7, 2020, 7:00 AM-3:30 PM
Conclusion: Dara-IRd is an active regimen in newly diagnosed MM, with high overall rates of response and deep responses that improved over time with therapy. Early discontinuation of dexamethasone does not appear to impact the depth, rate or kinetics of response. The toxicities were manageable, with dose modifications. All patients were able to collect stem cells when required, though majority needed plerixafor.
653.Myeloma: Therapy, excluding Transplantation| November 13, 2019
Phase 2 Trial of Daratumumab, Ixazomib, Lenalidomide and Modified Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma
Conclusion: Our early results suggest that the combination of daratumumab, ixazomib, lenalidomide and modified dose dexamethasone is well-tolerated, with excellent activity, and does not adversely impact stem-cell mobilization in patients with NDMM.