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NCT07334535

PHASE4

Isa-VRD in TIE HRMM

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Randomized, Multi-center Study Comparing Isatuximab in Combination With VRD Versus VRD in High-Risk, Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2026-01-30

Completion Date

2029-01

Last Updated

2026-01-13

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Isatuximab, bortezomib, lenalidomide, dexamethason

Participants in this group will receive the quadruplet induction-consolidation regimen of Isatuximab in combination with Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Isatuximab, Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.

DRUG

Bortezomib, Lenalidomide, Dexamethasone

Participants in this group will receive the standard triplet induction-consolidation regimen of Bortezomib, Lenalidomide, and Dexamethasone (VRD) for 12 cycles (each cycle is 28 days). This will be followed by a maintenance therapy with Bortezomib and Lenalidomide until disease progression or unacceptable toxicity.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Junling Zhuang

Beijing, Beijing Municipality, China