Condition: Multiple Myeloma · Sponsor: Shanghai Zhongshan Hospital
Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China. And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients Participants will: Receive Isatuximab 10 mg/kg iv * Cycle 1: Every weeks on Days 1, 8, 15, and 22 * Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m² * Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day * Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance \[CrCl\] ≥30 and \<60 mL/min) Receive Dexamethasone oral 20 mg * Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment. During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment. During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to …
This description comes directly from the study's public registry record.
Peng Liu · +86-021-64041990 · liu.peng@zs-hospital.sh.cn
Jiadai Xu · xu.jiadai@zs-hospital.sh.cn
Always discuss trial participation with your own doctor first.
| Peking Union Medical College Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong, China | Recruiting |
| Shenzhen People's Hospital | Shenzhen, Guangdong, China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Naning, Guangxi, China | Recruiting |
| Harbin Institute of Hematologic Oncology | Harbin, Heilongjiang, China | Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. | Wuhan, Hubei, China | Recruiting |
| Jiangsu Provincial People's Hospital | Nanjing, Jiangsu, China | Recruiting |
| Affiliated Hospital of Nantong University | Nantong, Jiangsu, China | Recruiting |
| Fudan University Affiliated Zhongshan Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
| Xijing Hospital, Air Force Medical University | Xi’an, Shanxi, China | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu, Sichuan, China | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07663253