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

NCT07663253 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 333

Last updated 2026-06-23

No results posted yet for this study

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 \<60 mL/min) Receive Dexamethasone oral 20 mg
* Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.

During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.

During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.

Conditions

Interventions

DRUG

Isatuximab

Isatuximab 10 mg/kg Intravenous (IV) infusion * Cycle 1: Every weeks on Days 1, 8, 15, and 22 * Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.

DRUG

Bortezomib

Bortezomib subcutaneous injection 1.3 mg/m² • Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

DRUG

Lenalidomide

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 \<60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen

DRUG

Dexamethasone

Dexamethasone oral 20 mg • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Peng Liu · Fudan University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-02-28
Completion
2030-09-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663253 on ClinicalTrials.gov