GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for 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

This trial tests whether GR1803 injection works better than daratumumab combined with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma who have had one to three prior treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone, daratumumab
• Locations: 1 site (Tianjin)
• Trial ID: NCT07452198 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized interventional comparison assigns participants to receive either GR1803 injection or daratumumab plus pomalidomide and dexamethasone (DPd). Eligible participants must have 1–3 prior lines of antimyeloma therapy including a proteasome inhibitor and lenalidomide (patients with only one prior line must be lenalidomide-refractory), measurable disease, and ECOG performance status 0–2. Disease response and progression are followed using standard IMWG criteria while participants receive the assigned regimen. The study is sponsored by Genrix (Shanghai) Biopharmaceutical and is recruiting at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences in Tianjin, China.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma who have had one to three prior therapies including a proteasome inhibitor and lenalidomide (with one-line patients required to be lenalidomide-refractory), have measurable disease, and ECOG 0–2 are the intended participants.

Not a fit: Patients without measurable disease, those who have had more than three prior therapy lines, or those unable to tolerate the study drugs are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, GR1803 could provide a more effective treatment option than the current daratumumab plus pomalidomide and dexamethasone regimen for people with relapsed or refractory multiple myeloma.

How similar studies have performed: Daratumumab plus pomalidomide and dexamethasone is an established effective regimen in relapsed/refractory myeloma, while GR1803 remains experimental with limited published Phase 3 data so far.

Eligibility criteria

Inclusion Criteria:

* 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; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion.
* 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 as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 5 gram per liter (g/L); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=100 mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Have clinical laboratory values within the specified range.
* Have an understanding of and comply with the clinical trial protocol requirements, voluntarily participate in the clinical trial, and sign the informed consent form.

Exclusion Criteria:

* Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or amyloidosis (including primary and secondary).
* History or clinical signs of central nervous system involvement or meningeal involvement of multiple myeloma .
* Received any prior B cell maturation antigen (BCMA)-directed therapy.
* Has disease that is considered refractory or intolerant to an anti-cluster of differentiation 38 (CD38) targeted therapy or Pomalidomide.
* Prior antitumor therapy, within 21 days (PI 、IMiDs or radiotherapy within 14 days, clinical trial vaccine within 28 days, Gene modified adoptive cell therapy within 3 months, allogeneic stem cell transplantation within 6 months, autologous stem cell transplantation within 12 weeks) prior to first dose of study drug.
* Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days prior to first dose of study drug.
* Grade \>= 2 peripheral neuropathy at screening.
* History of Guillain Barre Syndrome (GBS) or variant GBS.
* The following medical conditions: active infecion, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, Syphilis infection, thromboembolic events or cerebrovascular events less than or equal to (\<=) 6 m, seizure attacks less than or equal to (\<=) 6 m.
* Active malignancies other than relapsed/refractory multiple myeloma within 3 years prior to screening.
* Active autoimmune disease or history of autoimmune disease.
* Received a live, attenuated vaccine within 4 weeks before first dose of study drug.
* Have major surgery within 2 weeks before first dose of study drug.
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
* Pregnant, lactating female.

Where this trial is running

Tianjin

• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Gang An

Conditions Multiple Myeloma