Isa-VRD in TIE HRMM

Starting soon · Phase 4

Conditions studied: Multiple Myeloma

In brief

This is a multicenter, prospective, randomized controlled trial designed to compare the quadruplet regimen of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRD) with the standard triplet regimen (VRD) in newly diagnosed, transplant-ineligible patients with high-risk multiple myeloma (HRMM). Primary Hypothesis: The addition of isatuximab to VRD will significantly improve the MRD negativity rate at 12 months compared to VRD alone in HR-NDMM patients. Secondary Hypotheses: Isa-VRD will lead to higher overall response rates (ORR), deeper responses, and improved progression-free survival (PFS) and overall survival (OS). The safety profile of Isa-VRD will be manageable and consistent with the known safety profiles of its individual components.

Key facts

Study ID: NCT07334535
Run by: Peking Union Medical College Hospital
People needed: 117
Starts: 2026-01-30
Expected to finish: 2029-01-01
Last updated by the study team: 2026-01-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly diagnosed Multiple myeloma ，meeting the IMWG 2025 definition of high-risk MM (any one criterion):
(1) Del(17p) (>20% of plasma cells) and/orTP53 mutation or（2）One of these translocations cooccurring with 1q+ and/or del(1p32) , or t(4;14), or t(14;16), or t(14;20) or （3） Monoallelic del(1p32) along with 1q+ or biallelic del(1p32) or（4） High β2M (>5.5 mg/dL) with normal creatinine (<1.2 mg/dL) or（5）Or presents with any other high-risk feature: meeting diagnostic criteria for primary plasma cell leukemia or presence of extramedullary plasmacytoma at baseline;
Age ≥18 years and ≤80 years;
Not eligible for autologous hematopoietic stem cell transplantation or has declined transplantation for other reasons.
ECOG score 0-2
Expected survival time > 3 months
Sufficient organ function is defined as follows: absolute neutrophil count ≥ 1.0×10\^9/L, platelet count ≥ 50×10\^9/L (when the proportion of bone marrow plasma cells is <50%), hemoglobin ≥ 7.5 g/dL; total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance rate ≥ 30 mL/min; left ventricular ejection fraction ≥ 50%.
Fertile female or male subjects must agree to take effective contraceptive measures during the study period and within the specified time after the last administration.
Voluntarily participated in this study, signed the informed consent form, had good compliance, and was cooperative during the follow-up.

You may not qualify if…

Prior systemic anti-myeloma therapy;
Viral infections including HBV, HCV, HIV, etc.;
Serious cardiovascular and cerebrovascular diseases, such as: within 6 months before screening, myocardial infarction, unstable angina pectoris, severe arrhythmia, New York Heart Function Classification III-IV grade, or left ventricular ejection fraction <50%.
Severe neurological or mental disorders that affect the ability to give informed consent or comply with the protocol.
Had an allergic reaction to isatuximab, bortezomib, lenalidomide, dexamethasone or any excipients
Pregnant or lactating women.
Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study.
The researcher believes that there are any other circumstances unsuitable for participating in this study.

Where it is running

Junling Zhuang — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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