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A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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 observe the depth of response.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines

• Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):

‣ Absolute neutrophil count (ANC) ≥1.0×10⁹/L

⁃ Platelet count ≥50×10⁹/L

⁃ Calculated creatinine clearance ≥30 mL/min (using Cockcroft-Gault formula)

⁃ Total bilirubin ≤3× upper limit of normal (ULN)

• TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Harbin Institute of Hematologic Oncology
RECRUITING
Harbin
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Naning
Jiangsu Provincial People's Hospital
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Fudan University Affiliated Zhongshan Hospital
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
RECRUITING
Wuhan
Xijing Hospital, Air Force Medical University
RECRUITING
Xi’an
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Peng Liu
liu.peng@zs-hospital.sh.cn
+86-021-64041990
Backup
Jiadai Xu
xu.jiadai@zs-hospital.sh.cn
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2030-09
Participants
Target number of participants: 333
Treatments
Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone(Isa-VRd)regimen
Arm Description:~Isatuximab 10 mg/kg Intravenous injection~* Cycle 1: Every weeks on Days 1, 8, 15, and 22~* Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m²~* Cycles 1-8: Days 1, 8, and 15 of each cycle 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) 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
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov