Search Our Scientific Publications & Authors

Publications
find publications by category +
Translate page:

Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study.

Authors:
Shinsuke Iida Takayuki Ishikawa Chang Ki Min Kihyun Kim Su Peng Yeh Saad Z Usmani Maria-Victoria Mateos Hareth Nahi Christoph Heuck Xiang Qin Dolly A Parasrampuria Katharine S Gries Ming Qi Nizar Bahlis Shigeki Ito

Ann Hematol 2021 Apr 18;100(4):1065-1077. Epub 2021 Feb 18.

Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Morioka, Iwate, Japan.

The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were double refractory. Co-primary endpoints were overall response rate (ORR) and maximum trough concentration (C). Secondary endpoints included rates of infusion-related reactions, progression-free survival, and patient-reported satisfaction with therapy. Sixty-seven Asian patients (DARA SC, n = 30; DARA IV, n = 37) were randomized, including 42 Japanese patients (DARA SC, n = 18; DARA IV, n = 24). Comparable ORRs for DARA SC versus DARA IV were seen in the Asian cohort (66.7% vs 43.2%) and Japanese-only cohort (61.1% vs 54.2%), including patients weighing ≤ 65 kg. Similarity of C was seen in both Asian and Japanese-only cohorts; the ratio of the geometric mean of the C concentrations for DARA SC/DARA IV was 143.96% (90% confidence interval (CI), 112.03-185.00%) and 148.02% (90% CI, 113.32-193.34%), respectively. The Asian cohort (both treatment groups) and Japanese-only cohort (DARA SC group) experienced higher rates of grade 3/4 cytopenias compared with the global COLUMBA population, occurring predominantly in patients of low bodyweight; no patients discontinued treatment due to cytopenias. The Cancer Therapy Satisfaction Questionnaire results generally favored DARA SC. In the Asian and Japanese-only cohorts, DARA SC was comparable to DARA IV. The efficacy, pharmacokinetic, safety, and satisfaction results were generally consistent with the global COLUMBA population regardless of patient bodyweight. ClinicalTrials.gov Identifier: NCT03277105.

Download full-text PDF

 Source
http://dx.doi.org/10.1007/s00277-021-04405-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7960612PMC
April 2021

Publication Analysis

Top Keywords

dara
13
asian patients
12
columba population
8
multiple myeloma
8
dara asian
8
myeloma subgroup
8
daratumumab dara
8
japanese-only cohorts
8
patients dara
8
phase columba
8
asian japanese-only
8
patients
8
subcutaneous daratumumab
8
japanese-only cohort
8
global columba
8
columba study
8
asian cohort
8
asian
7
columba
5
patients discontinued
4

Keyword Occurance

Similar Publications

Prevalence of SARS-CoV-2 in Communities Through Wastewater Surveillance-a Potential Approach for Estimation of Disease Burden.

Authors:
Prosun Bhattacharya Manish Kumar Md Tahmidul Islam Rehnuma Haque Sudip Chakraborty Arslan Ahmad Nabeel Khan Niazi Zeynep Cetecioglu David Nilsson Julian Ijumulana Tom van der Voorn Md Jakariya Maqsud Hossain Firoz Ahmed Mahbubur Rahman Nargis Akter Dara Johnston Kazi Matin Ahmed

Curr Pollut Rep 2021 Apr 6:1-7. Epub 2021 Apr 6.

Department of Geology, University of Dhaka, Dhaka, 1000 Bangladesh.

The episodic outbreak of COVID-19 due to SARS-CoV-2 is severely affecting the economy, and the global count of infected patients is increasing. The actual number of patients had been underestimated due to limited facilities for testing as well as asymptomatic nature of the expression of COVID-19 on individual basis. Tragically, for emerging economies with high population density, the situation has been more complex due to insufficient testing facilities for diagnosis of the disease. Read More

View Article and Full-Text PDF
April 2021
Similar Publications

A reliable interictal EEG grading scale for children with infantile spasms - The 2021 BASED score.

Authors:
John R Mytinger Jorge Vidaurre Melissa Moore-Clingenpeel Joseph R Stanek Dara V F Albert

Epilepsy Res 2021 Apr 2;173:106631. Epub 2021 Apr 2.

Department of Pediatrics, Division of Pediatric Neurology, Nationwide Children's Hospital, The Ohio State University, Columbus, OH 43205, USA. Electronic address:

Objective: To develop an improved interictal electroencephalogram (EEG) grading scale for children with infantile spasms founded on elements with adequate inter-rater reliability (IRR) to justify its further study for clinical and research purposes.

Methods: Three blinded reviewers assessed five-minute sleep epochs in 93 EEGs from 62 children (31 consecutive controls, 31 consecutive infantile spasms [pretreatment and posttreatment studies]) using a longitudinal bipolar montage. We determined the IRR of background amplitude, epileptiform discharges, >3 spike foci (including <50 % or >50 %), grouped multifocal spikes, paroxysmal voltage attenuations, and symmetry of sleep spindles. Read More

View Article and Full-Text PDF
April 2021
Similar Publications

Venous thromboembolism in patients with multiple myeloma receiving daratumumab-based regimens: a analysis of phase 3 clinical trials.

Authors:
Jiasheng Wang Changsu Park Raul Arroyo-Suarez

Leuk Lymphoma 2021 Apr 9:1-8. Epub 2021 Apr 9.

Department of Internal Medicine, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.

It is unknown if daratumumab could affect venous thromboembolism (VTE) risks in patients with multiple myeloma (MM). In this study, individual participant data from three trials comparing daratumumab (DARA) and non-DARA regimens, the CASTOR, PULLOX and MAIA trial, were pooled into two groups. A total of 896 and 899 patients received DARA and non-DARA regimens, respectively. Read More

View Article and Full-Text PDF
April 2021
Similar Publications

A review of the BCG vaccine and other approaches toward tuberculosis eradication.

Authors:
Thomas Cho Christopher Khatchadourian Huy Nguyen Yash Dara Shuna Jung Vishwanath Venketaraman

Hum Vaccin Immunother 2021 Mar 26:1-17. Epub 2021 Mar 26.

College of Osteopathic Medicine of the Pacific, Western University of Health Sciences, Pomona, CA, USA.

Despite aggressive eradication efforts, Tuberculosis (TB) remains a global health burden, one that disproportionally affects poorer, less developed nations. The only vaccine approved for TB, the Bacillus of Calmette and Guérin (BCG) vaccine remains controversial because it's stated efficacy has been cited as anywhere from 0 to 80%. Nevertheless, there have been exciting discoveries about the mechanism of action of the BCG vaccine that suggests it has a role in immunization schedules today. Read More

View Article and Full-Text PDF
March 2021
Similar Publications

Severe drug-induced immune hemolysis due to ceftriaxone.

Authors:
Ravi C Dara Rakesh Sharma Himanshu Bhardwaj

Asian J Transfus Sci 2020 Jul-Dec;14(2):187-191. Epub 2020 Dec 19.

Department of Transfusion Medicine, Manipal Hospitals, Jaipur, Rajasthan, India.

Drug-induced immune hemolytic anemia (DIIHA) is a rare condition that results primarily due to drug-induced antibodies, either drug dependent or drug independent. For its diagnosis, specialized immunohematology laboratory is often required for performing complex serological tests. The exact incidence of DIIHA is not known, but as per data published by Garratty, the incidence of DIIHA is estimated to be one in million population. Read More

View Article and Full-Text PDF
December 2020
Similar Publications