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RECRUITING
NCT07623798
PHASE3

A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd or SVd)

Official title: A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2026-06-11

Completion Date

2029-12-31

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DRUG

Pomalidomide Capsules

1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21; 2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;

DRUG

Bortezomib for Injection

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

DRUG

Daratumumab Injection (Subcutaneous Injection)

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

DRUG

IBI3003

According to body weight

DRUG

Selinexor Tablets

The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8,15,22 and 29 ,100 mg/d orally.

Locations (1)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, China