Adding isatuximab to a standard drug combination for high-risk multiple myeloma
Compares isatuximab plus standard drugs with standard drugs alone in newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: Isa-VRD in TIE HRMM
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07334535, who can take part
Where in China
- Junling ZhuangBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07334535
- Record updated
- 13 January 2026
- Original description
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).Read full original descriptionShow less
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.
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.
Inclusion: 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: Prior systemic anti-myeloma therapy; Participated in other interventional clinical studies, or had received other anti-tumor treatments within the specified time before the first administration of this study; Viral infections including HBV, HCV, HIV, etc; 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; 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%; Pregnant or lactating women; The researcher believes that there are any other circumstances unsuitable for participating in this study.