|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
A daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone (Dara-CVRd) induction combination with augmented high-dose melphalan (HDMEL) and bortezomib-augmented autologous stem cell transplantation (ASCT) shows a high response rate among patients with ultra high-risk, newly diagnosed multiple myeloma (MM) or plasma cell leukemia (PCL), according to research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Patients with ultra high-risk MM or PCL have poor outcomes, and represent a population that badly need novel therapy options. These patients are, further, not well-represented in clinical trials. Based on recent findings that anti-CD38 antibodies may be effective in newly diagnosed MM, researchers designed the OPTIMUM/MUKnine study (ClinicalTrials.gov Identifier: NCT03188172) to evaluate the safety and efficacy of Dara-CVRd among patients with ultra high-risk, newly diagnosed MM or PCL.
A total of 107 patients, who were included in the study’s safety population, were recruited to OPTIMUM between September 2017 and July 2019. The study’s primary endpoints were minimal residual disease (MRD) status after ASCT and progression-free survival (PFS). In this presentation, the authors reported findings from the induction phase and at 100 days after ASCT.
The median follow-up was 22.2 months. At the end of the induction phase, in the intention-to-treat population, the overall response rate was 94%, with 21.5% of patients reaching a complete response; 0.9% of patients had progressive disease. During this phase, 2 patients died from infection. Of the 81% of patients who were evaluable for MRD status, 41% of patients were MRD-negative.
At day 100 after ASCT, the overall response rate was 83%, with 47% of patients having a complete response; 7% of patients had progressive disease. Of the 78% of patients evaluable for MRD status at this timepoint, 64% of patients were MRD-negative.
Patients with PCL tended to have a lower response rate at day 100 after ASCT, with 22% of patients reaching a complete response and 22% of patients having progressive disease.
The most frequently noted grade 3 or 4 adverse events during the induction phase were neutropenia (21%), thrombocytopenia (12%) and infection (12%).
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Kaiser MF, Hall A, Walker K, et al. Depth of response and minimal residual disease status in ultra high-risk multiple myeloma and plasma cell leukemia treated with daratumumab, bortezomib, lenalidomide, cyclophosphamide and dexamethasone (Dara-CVRd): results of the UK optimum/MUKnine trial. J Clin Oncol. 2021;39:(suppl 15; abstr 8001). doi:10.1200/JCO.2021.39.15_suppl.8001