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Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma
MA. Dimopoulos, PM. Voorhees, F. Schjesvold, YC. Cohen, V. Hungria, I. Sandhu, J. Lindsay, RI. Baker, K. Suzuki, H. Kosugi, MD. Levin, M. Beksac, K. Stockerl-Goldstein, A. Oriol, G. Mikala, G. Garate, K. Theunissen, I. Spicka, AK. Mylin, S....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III, Multicenter Study, Comparative Study
NLK
ProQuest Central
from 1980-01-03 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Health & Medicine (ProQuest)
from 1980-01-03 to 3 months ago
Family Health Database (ProQuest)
from 1980-01-03 to 3 months ago
Psychology Database (ProQuest)
from 1980-01-03 to 3 months ago
Health Management Database (ProQuest)
from 1980-01-03 to 3 months ago
Public Health Database (ProQuest)
from 1980-01-03 to 3 months ago
PubMed
39652675
DOI
10.1056/nejmoa2409029
Knihovny.cz E-resources
- MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Smoldering Multiple Myeloma * diagnosis mortality therapy MeSH
- Injections, Subcutaneous MeSH
- Kaplan-Meier Estimate MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Myeloma * diagnosis epidemiology prevention & control MeSH
- Antibodies, Monoclonal * administration & dosage adverse effects MeSH
- Watchful Waiting * statistics & numerical data MeSH
- Disease Progression MeSH
- Antineoplastic Agents * administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved. METHODS: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria. RESULTS: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified. CONCLUSIONS: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.).
Albert Schweitzer Hospital Dordrecht the Netherlands
Alexandra General Hospital National and Kapodistrian University of Athens Athens
Ankara University Ankara Turkey
Charles University and General Hospital Prague Czech Republic
Clínica Medica São Germano São Paulo
Cross Cancer Institute University of Alberta Edmonton Canada
GMMG Study Group at University Hospital Heidelberg Internal Medicine 5 Heidelberg Germany
Institut Català d'Oncologia and Institut Josep Carreras Hospital Germans Trias i Pujol Barcelona
Institute of Hematology and Transfusion Medicine Warsaw Poland
Janssen Research and Development Beerse Belgium
Janssen Research and Development Raritan NJ
Janssen Research and Development Shanghai China
Janssen Research and Development Spring House PA
Janssen Scientific Affairs Horsham PA
Japanese Red Cross Medical Center Tokyo
Jessa Hospital Hasselt Belgium
Kent and Canterbury Hospital Canterbury United Kingdom
Knight Cancer Institute Oregon Health and Science University Portland
Levine Cancer Institute Atrium Health Wake Forest University School of Medicine Charlotte NC
Medical Unit Hematology Karolinska University Hospital Stockholm
Ogaki Municipal Hospital Ogaki City Japan
Oslo Myeloma Center Department of Hematology Oslo University Hospital Oslo
Perth Blood Institute Murdoch University Perth WA Australia
Rigshospitalet University of Copenhagen Copenhagen
Tel Aviv Sourasky Medical Center and Tel Aviv University Tel Aviv Israel
University Hospital Hôtel Dieu Nantes France
University Hospital of Salamanca IBSAL and Cancer Research Center IBMCC Salamanca Spain
University of Washington and Fred Hutchinson Cancer Center Seattle
References provided by Crossref.org
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