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FUMANBA-03NCT06464991

A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites expanded: 28 → 41 locations
    • Enrollment target: 240 to 260
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 16 to 15
  2. Study Identification, Study Statusv3
  3. Primary endpoint revised
    • Study sites: 26 to 28
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 14 to 16
    v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Minimal Residual Disease (MRD)-negative complete response (CR) rate at 12 months
Timeframe: 12 months (+/-3 months) post-randomization
Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC)
Timeframe: up to 5 years from randomization

Secondary (15)

Overall MRD negativity rate
Duration of MRD negativity
Complete Response Rate（CRR）
Very good partial response or better response (≥VGPR) rate
Overall Response Rate（ORR）
Show 10 moreShow less
Duration of Response (DOR)
Event-Free Survival (EFS)
Overall Survival（OS）
Time to Next Treatment（TTNT）
Incidence of Adverse events
Pharmacokinetic Endpoint-Cmax
Pharmacokinetic Endpoint-Tmax
Pharmacokinetic Endpoint-AUC
Pharmacodynamic Endpoint
Health Related Quality of Life Endpoint

Arms and interventions

Experimental groupExperimental

Drug:Equecabtagene Autoleucel Injection

Control groupActive comparator

Drug: Daratumumab, Bortezomib, Dexamethasone, Pomalidomide, DPd group: Daratumumab, Pomalidomide, Dexamethasone PVd group: Bortezomib, Dexamethasone, Pomalidomide

Drugs: Equecabtagene Autoleucel Injection, Daratumumab, Pomalidomide, Bortezomib, Dexamethasone

Sites

41 sites in 2 countries

China 28, Japan 13