MedicalResearch.com Interview with:
Craig C. Hofmeister, MD, MPH
The Ohio State University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Preliminary data presented from the randomized, open-label, Phase 2 CENTAURUS (SMM2001) study evaluated three dosing schedules for DARZALEX monotherapy in patients with intermediate or high-risk smoldering multiple myeloma. A total of 123 patients were enrolled, with a median time since initial smoldering multiple myeloma diagnosis of 6.83 months (0.4-56). Patients were randomized to one of three treatment arms receiving DARZALEX 16 mg/kg intravenously in 8-week cycles: 1.) a long-intense dosing schedule (LONG) where DARZALEX was administered weekly in Cycle 1, every other week in Cycle 2-3, every 4 weeks in Cycle 4-7, and every 8 weeks up to Cycle 20; 2.) an intermediate dosing schedule (INT), where DARZALEX was given weekly for 1 cycle, and every 8 weeks up to Cycle 20 and; 3.) a short intense dosing schedule (SHORT), where DARZALEX was given weekly for 1 cycle. Results from the study showed DARZALEX monotherapy had a tolerable safety profile in patients with intermediate or high-risk smoldering multiple myeloma, with the most common treatment-emergent adverse events (TEAEs) being fatigue, cough, headache and insomnia. The efficacy endpoints included overall response rate, progression free survival, time to next treatment, and overall survival rate at 4 years. These study results serve as the basis for a Phase 3 study for DARZALEX in smoldering multiple myeloma, which is actively enrolling. These findings demonstrated DARZALEX had a manageable safety profile in patients with intermediate or high-risk smoldering multiple myeloma.
MedicalResearch.com: What should readers take away from your report?
Response: DARZALEX data from various clinical trials presented at ASH show:
- The promise of DARZALEX for newly-diagnosed multiple myeloma patients, in the frontline setting as a new standard of care.
- DARZALEX combination therapy continues to provide long-term clinical benefit in patients with relapsed or refractory multiple myeloma over time
- DARZALEX had a manageable safety profile in patients with intermediate or high-risk smoldering multiple myeloma.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Despite the availability of existing treatment options, multiple myeloma is still an incurable blood cancer that causes significant suffering from multiple organs involvement and ultimately leads to death. The data presented at ASH demonstrates potential of DARZALEX in both smoldering multiple myeloma and in the frontline setting for newly diagnosed patients, and also in providing continued long-term clinical benefit in patients with relapsed or refractory multiple myeloma
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Daratumumab Monotherapy for Patients with Intermediate or High-Risk Smoldering Multiple Myeloma (SMM): Centaurus, a Randomized, Open-Label, Multicenter Phase 2 Study
Program: Oral and Poster Abstracts
Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapy in Myeloma and Amyloid
Sunday, December 10, 2017: 5:45 PM
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