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Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients

Recruitingn/aAges 18 Years - anyAllShanghai Zhongshan Hospital
NCT07663253 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 cy

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * Patients currently participating in other interventional clinical studies * Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients * Severe bacteremia at the time of administration * Currently uncontrolled cardiovascular disease, including: * Uncontrolled hypertension * Uncontrolled arrhythmia * Uncontrollable congestive heart failure * Unstable angina * Patients with peripheral neuropathy ≥Grade 2 * Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C * Patients who are currently pregnant * Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen
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What it tests

  • Isatuximab
  • Bortezomib
  • Lenalidomide
  • Dexamethasone
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Where

13 sites
Peking Union Medical College Hospital
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
The First Affiliated Hospital of Guangxi Medical University
Naning, China
Harbin Institute of Hematologic Oncology
Harbin, China
Henan Cancer Hospital
Zhengzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
Wuhan, China
Jiangsu Provincial People's Hospital
Nanjing, China

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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