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A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04939142 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-02-11

No results posted yet for this study

Summary

This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).

Conditions

Interventions

COMBINATION_PRODUCT

SVd (Selinexor+Bortezomib+dexamethasone)

Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)

COMBINATION_PRODUCT

Vd (Bortezomib+dexamethasone)

Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])

Sponsors & Collaborators

  • Antengene Corporation

    lead INDUSTRY

Principal Investigators

  • Jin Lu, PhD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04939142 on ClinicalTrials.gov