Acta Medica Okayama volume73 issue6
2019-12 発行

Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Over 75 Years Old with Alternating Bortezomib/dexamethasone and Lenalidomide/dexamethasone: the MARBLE Trial

Yokoyama, Akihiro Division of Hematology, Department of Internal Medicine, NHO Tokyo Medical Center
Kada, Akiko Department of Clinical Trials and Research, Clinical Research Center, NHO Nagoya Medical Center
Saito, Akiko M. Department of Clinical Trials and Research, Clinical Research Center, NHO Nagoya Medical Center
Sawamura, Morio Department of Hematology, NHO Shibukawa Medical Center
Komeno, Takuya Department of Hematology, NHO Mito Medical Center
Sunami, Kazutaka Department of Hematology, NHO Okayama Medical Center
Takezako, Naoki Department of Hematology, Disaster Medical Center of Japan
Publication Date
2019-12
Abstract
Elderly multiple myeloma (MM) patients, who are generally ineligible for transplantation, have high risks of death and treatment discontinuation, and require a regimen incorporating novel agents that balance safety, tolerability, and efficacy. We evaluated alternating bortezomib-dexamethasone and lenalidomide-dexamethasone treatments administered over a 63-day cycle in transplant-ineligible elderly patients with newly diagnosed MM. Subcutaneous bortezomib 1.3 mg/m2 was administered weekly on Days 1, 8, 15, and 22; oral lenalidomide 15 mg daily on Days 36-56; and oral dexamethasone 20 mg on Days 1, 8, 15, 22, 36, 43, 50, and 57 for 6 cycles. The primary endpoint was the overall response rate.
Document Type
Clinical Study Protocol
Keywords
bortezomib
lenalidomide
dexamethasone
myeloma
Link to PubMed
Thumnail 73_6_547.pdf 1.95 MB