All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.
The mm Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mm Hub cannot guarantee the accuracy of translated content. The mm and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View mm content recommended for you
ALCYONE final analysis: Efficacy and safety of VPM vs D-VPM in transplant-ineligible NDMM
Daratumumab (D) combinations are recommended in guidelines by the European Hematology Association (EHA) and the European Society of Medical Oncology (ESMO) and are considered the SoC for transplant-ineligible patients with NDMM. The primary analysis of the phase III ALCYONE trial (NCT02195479) demonstrated longer PFS with D-VMP vs VMP, with no increased toxicity. Pre-specified subgroup analyses of ALCYONE continued to demonstrate improved survival outcomes. The final safety and efficacy analysis of the ALCYONE trial was published by Mateos et al. in The Lancet Oncology.1 Patients who were ineligible for transplant due to age (≥65 years) or substantial comorbidities and had an ECOG PS of 0–2 (N = 706) were included. Patients were randomized 1:1 to receive either D-VMP (n = 350) or VMP (n = 356). This final analysis reported secondary endpoints including MRD-negativity rate, time to next therapy, PFS, OS, and safety. The median follow-up was 86.7 months.
|
Key learnings |
MRD-negativity rates (10-5) were higher in the D-VMP vs VMP groups (28% vs 7%; OR, 5.23; 95% CI: 3.27–8.36; p < 0.0001) and were sustained at 6 and 12 months (p < 0.0001 each). |
The median time to next antimyeloma therapy was longer in the D-VMP group compared with the VMP group (66.8 months vs 25.9 months; HR, 0.37; 95% CI: 0.30–0.46; p < 0.0001). |
The median OS (83.0 months vs 53.6 months; HR, 0.56; 95% CI: 0.46–0.68; p < 0.0001) and PFS on next line of therapy (66.7 months vs 42.4 months; HR, 0.56; 95% CI: 0.46–0.68; p < 0.0001) were longer in the D-VMP vs VMP group. |
No new safety signals were identified, and the rates of TEAEs were similar in the D-VMP vs VMP groups (98% vs 97%, respectively). The most frequently reported TEAEs were neutropenia (51% vs 53%), thrombocytopenia (50% vs 54%), and anemia (32% vs 37%) in the D-VMP vs VMP groups, respectively. |
The final analysis of ALCYONE continues to support the efficacy and safety of D-VMP as the front-line therapy of choice for transplant-ineligible patients with NDMM. |
CI, confidence interval; D-VMP, daratumumab, bortezomib, melphalan, prednisone; ECOG, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; OR, odds ratio; OS, overall survival; PFS, progression-free survival; SoC, standard of care; TEAE, treatment-emergent adverse event; VMP, bortezomib, melphalan, prednisone.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
What is the most significant limitation you have identified when using lenalidomide or pomalidomide for the treatment of patients with multiple myeloma?
