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.
Study ID
NCT07452198
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GR1803 injection — DRUG
    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.
  • Daratumumab — DRUG
    Participants received subcutaneous Daratumumab at a dose of 1800 mg.
  • Pomalidomide — DRUG
    Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days).
  • Dexamethasone — DRUG
    Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (\>75 years).

Study Details

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

Key Dates

Start date
Mar 9, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
358 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: GR1803 Injection
  • Active Comparator: Arm B: DPd

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

Related Studies