Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma
Open accessAbstract
Key Points: A pooled analysis of 2 daratumumab trials showed no new safety signals, an overall response rate of 31%, and deep and durable responses. Median overall survival was 20.1 months; benefit was also shown in patients who achieved minimal response/stable disease.
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In an open-label, multicentre, dose-escalation phase Ib study of subcutaneous daratumumab 1200 mg (n = 8) and 1800 mg (n = 33), infusion-related reactions were reported in 9 of 41 patients (22%) and were mostly grade 1/2 in severity.
“IRRs were reported in 9 of 41 patients (22%) and were mostly grade 1/2 in severity”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [82]
No infusion-related reactions were reported with subsequent subcutaneous daratumumab infusions in the phase Ib study.
“No IRRs were reported with subsequent infusions [82].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [82]
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- Authors
- Usmani, S. Z., Weiss, B. M., Plesner, T., Bahlis, N. J., Belch, A., Lonial, S., Lokhorst, H. M., Voorhees, P. M., Richardson, P. G., Chari, A., Sasser, A. K., Axel, A., Feng, H., Uhlar, C. M., Wang, J., Khan, I., Ahmadi, T., & Nahi, H.
- Affiliations
- Carolinas Healthcare System (US)
- Abramson Cancer Center (US)
- University of Southern Denmark (DK)
- University of Calgary (CA)
- Cross Cancer Institute (CA)
- Emory University (US)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- University of North Carolina at Chapel Hill (US)
- Harvard University (US)
- Tisch Cancer Institute (US)
- Janssen Research & Development, LLC, Spring House, PA;
- Janssen Research & Development (United States) (US)
- Karolinska University Hospital (SE)
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2016-07-07
- Volume
- 128
- Issue
- 1
- Pages
- 37-44
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- PMC
- PMC4937359
- OpenAlex
- W2402003835
- Cited by
- 407
- References
- 24
- Citations by year
- 2026: 5 · 2025: 18 · 2024: 21 · 2023: 36 · 2022: 37 · 2021: 55 · 2020: 71 · 2019: 44 · 2018: 54 · 2017: 49 · 2016: 17
- FWCI
- 51.97
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Blood (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Janssen Research and Development
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- daratumumab, multiple myeloma, relapsed/refractory multiple myeloma, monotherapy, progression-free survival, overall survival, response rate, duration of response, drug safety
- MeSH terms
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Myeloma, Recurrence, Remission Induction, Survival Rate, Disease-Free Survival
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