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RECRUITING
NCT07452198
PHASE3

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).

Official title: A Phase 3, Multicenter, Open-Label, Randomized Study Comparing GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy Including Lenalidomide and Proteasome Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2026-03-09

Completion Date

2030-03

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

GR1803 injection

Participants received intravenous GR1803 injection at a dose of 180 ug per kilogram, which had been preceded by step-up doses of 10 and 30 ug per kilogram.

DRUG

Daratumumab

Participants received subcutaneous Daratumumab at a dose of 1800 mg.

DRUG

Pomalidomide

Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days).

DRUG

Dexamethasone

Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (\>75 years).

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China