Two Phase III Trials Evaluating Daratumumab-Based Therapies for Multiple Myeloma
Posted: Tuesday, September 10, 2019
After daratumumab demonstrated safety and activity when added to bortezomib, lenalidomide, and dexamethasone (D-Vrd) in the phase II GRIFFIN study, two clinical trials are underway to compare this four-drug regimen with the standard triplet regimen in patients with multiple myeloma. Presented at the 2019 American Society of Clinical Oncology and published in the Journal of Clinical Oncology, the ongoing phase III PERSEUS trial (Abstract TPS8055), conducted by Pieter Sonneveld, MD, PhD, of the Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, and colleagues, is evaluating the safety and efficacy of the four-drug combination among patients with transplant-eligible newly diagnosed multiple myeloma. In the CEPHEUS trial (Abstract TPS8056), Sonja Zweegman, MD, PhD, of the Amsterdam University Medical Center, and colleagues are assessing the the four-drug regimen in the same patient population, although for their study patients, transplantation is not planned as initial therapy.
In the PERSEUS trial, the investigators plan to stratify 690 patients with newly diagnosed multiple myeloma by International Staging System Stage and cytogenetic risk. All patients will be administered Vrd, and half will also receive subcutaneous daratumumab. The primary endpoint will be progression-free survival.
In the CEPHEUS trial, the investigators intend to enroll 360 patients with newly diagnosed multiple myeloma who do not plan to use transplantation as an initial therapy. The patients will also be stratified by International Staging System stage, as well as age and transplant eligibility. Again, all of the patients will be treated with Vrd, with half also receiving subcutaneous daratumumab. The authors have designated a minimal residual disease negative rate of 10–5 sensitivity threshold as the primary endpoint.