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