Isa-VRD in TIE HRMM

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.

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.

Sponsors & Collaborators

• Handan Central Hospital

  collaborator OTHER

• Inner Mongolia People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• North China University of Science and Technology

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Beijing Jishuitan Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Beijing Hospital

  collaborator OTHER_GOV

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Junling Zhuang · Peking Union Medical College, department of hematology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-30

Primary Completion

2028-07-31

Completion

2029-01-31

Countries

• China

Study Locations