Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
34520219
DOI
10.1200/jco.21.01045
Knihovny.cz E-resources
- MeSH
- Bortezomib administration & dosage adverse effects MeSH
- Time Factors MeSH
- Dexamethasone administration & dosage adverse effects MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Consolidation Chemotherapy MeSH
- Lenalidomide administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Multiple Myeloma drug therapy mortality pathology MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage adverse effects MeSH
- Neoplasm, Residual MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Maintenance Chemotherapy MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Bortezomib MeSH
- Dexamethasone MeSH
- Lenalidomide MeSH
PURPOSE: To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial. PATIENTS AND METHODS: The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS). RESULTS: Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response ≥ complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively (P < .001). Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without (P < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease-negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable. CONCLUSION: Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone.
Albert Schweitzer Ziekenhuis Dordrecht the Netherlands
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy
Department of Haematology Aalborg University Hospital Aalborg Denmark
Department of Haematology Alfred Hospital Monash University Melbourne Australia
Department of Hematology Ankara University School of Medicine Ankara Turkey
Department of Hematology Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Hematology Haga Ziekenhuis The Hague the Netherlands
Department of Hematology HOVON Data Center Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Hematology Oslo University Hospital Oslo Norway
Department of Hematology Radboud University Medical Centre Nijmegen the Netherlands
Department of Hematology St Olav Hospital Trondheim Norway
Department of Hematology University Medical Centre Utrecht the Netherlands
Department of Hematology ZNA Stuivenberg Antwerp Belgium
Department of Immunology Erasmus MC Cancer Institute Rotterdam the Netherlands
Department of Oncology Hematology Kantonsspital St Gallen Switzerland
HOVON Data Center Erasmus MC Cancer Institute Rotterdam the Netherlands
IRCCS Azienda Ospedaliero Universitaria di Bologna Istituto di Ematologia Seràgnoli Bologna Italy
Maastricht University Medical Center Maastricht the Netherlands
Medical Oncology Luzerner Kantonshospital Luzern Switzerland
Ospedale San Camillo Forlanini Rome Italy
Sahlgrenska University Hospital Gothenburg Sweden
University Hospital Brno Brno Czech Republic
University Hospital Ostrava Ostrava Czech Republic
Wilhelminen Cancer Research Institute c o Wilhelminenspital Vienna Austria
References provided by Crossref.org
ClinicalTrials.gov
NCT01208766
