The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
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.
Participants received subcutaneous Daratumumab at a dose of 1800 mg.
Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days).
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGProgression Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Progression Free Survival on Next-line Therapy (PFS2)
Time frame: Up to 5 years
Overall Response (Partial Response [PR] or Better)
Time frame: Up to 5 years
Complete Response (CR) or Better
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Duration of Complete Response
Time frame: Up to 5 years
Time to Response
Time frame: Up to 5 years
Minimal Residual Disease (MRD)-negativity
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 5 years
Serum Concentration of GR1803 Injection
Time frame: Up to 5 years
Number of Participants with Anti-drug Antibodies (ADAs) to GR1803 Injection
Time frame: Up to 5 years
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Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (\>75 years).
Change from Baseline in Overall Health-related Quality of Life as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
The EQ-5D-5L ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Up to 5 years