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A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: Arm A: GR1803 InjectionExperimental treatment 1 intervention
Group B: Arm B: DPdActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time frame
Up to 5 years

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to 5 years
2

Progression Free Survival on Next-line Therapy (PFS2)

Time frame
Up to 5 years
3

Overall Response (Partial Response [PR] or Better)

Time frame
Up to 5 years
4

Complete Response (CR) or Better

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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