Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07663253

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

Conditions: Multiple Myeloma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 333
Sponsor: Shanghai Zhongshan Hospital

Location: Peking Union Medical College Hospital Beijing Beijing Municipality

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 \

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663253). StuddyBuddy aggregates publicly available trial information.