A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd or SVd)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
Serum M-protein ≥ 5 g/L（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）
Urine M-protein ≥200 mg/24h
Disqualifiers
Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.
Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.
Have history of primary immunodeficiency.
Trial design
Design model
Parallel
Treatments tested in this trial
Pomalidomide Capsules
Drug1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21; 2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;
Bortezomib for Injection
DrugThe PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.
Daratumumab Injection (Subcutaneous Injection)
DrugThe DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.
IBI3003
DrugAccording to body weight
Selinexor Tablets
DrugThe SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally.
Treatment groups
255 Participants
are divided into 2 treatment groupsGroup A: the investigator's choice regimen (DPd or PVd or SVd)Active comparator 4 interventions
Group B: IBI3003Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS assessed by independent review committee
PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria
Time frame
up to 24 months after the last enrolled participant receives the first dose of study drugSecondary outcomes
1
PFS assessed by investigator
PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria
Time frame
up to 24 months after the last enrolled participant receives the first dose of study drug2
Negativity rate of minimal residual disease (MRD)
Defined as the proportion of participants achieving MRD-negative status
Time frame
up to 24 months after the last enrolled participant receives the first dose of study drug3
Sustained MRD negativity rate
Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year
Time frame
up to 24 months after the last enrolled participant receives the first dose of study drug4
6-month MRD negativity rate.
The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization
Time frame
up to 24 months after the last enrolled participant receives the first dose of study drugSponsors and contacts
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Source ClinicalTrials.gov