Trials / Recruiting
RecruitingNCT07452198
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 358 (estimated)
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2026-03-09
- Primary completion
- 2029-03-01
- Completion
- 2030-03-01
- First posted
- 2026-03-05
- Last updated
- 2026-03-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07452198. Inclusion in this directory is not an endorsement.