Actively Recruiting
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2026-03-25
358
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
CONDITIONS
Official Title
A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and baseline.
- Diagnosed as multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG) diagnostic criteria.
- Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; participants with only 1 prior line must be lenalidomide refractory.
- Documented evidence of progressive or stable disease based on investigator's determination of response by IMWG criteria on or after their last regimen.
- Measurable disease at screening and baseline defined by serum M-protein ≥ 5 g/L, or urine M-protein ≥ 200 mg/24 hours, or serum immunoglobulin free light chain ≥100 mg/L with abnormal kappa lambda ratio.
- Have clinical laboratory values within the specified range.
- Understand and comply with the clinical trial protocol and provide informed consent.
You will not qualify if you...
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.
- History or clinical signs of central nervous system or meningeal involvement of multiple myeloma.
- Received any prior B cell maturation antigen (BCMA)-directed therapy.
- Disease refractory or intolerant to anti-CD38 targeted therapy or pomalidomide.
- Prior antitumor therapy within 21 days before first study drug dose.
- Received corticosteroids equivalent to ≥140 mg prednisone within 14 days before first study drug dose.
- Grade ≥ 2 peripheral neuropathy at screening.
- History of Guillain Barre Syndrome or variant.
- Active infections including HIV, hepatitis B or C, syphilis, recent thromboembolic or cerebrovascular events, or seizures within 6 months.
- Active malignancies other than relapsed/refractory multiple myeloma within 3 years.
- Active or history of autoimmune disease.
- Received live attenuated vaccine within 4 weeks before first study drug dose.
- Major surgery within 2 weeks before first study drug dose.
- Contraindications or life-threatening allergies to study drugs or excipients.
- Pregnant or lactating females.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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