This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).
This is a Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM). About 150 subjects are planned to be enrolled in this study, and be randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm): (1) SVd Arm (\~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
Vd Arm (\~50): Bortezomib (Cycles 1-8 \[BIW\], Cycles ≥ 9 \[QW\]) + dexamethasone (Cycles 1-8 \[Four times a week\], Cycles ≥ 9 \[BIW\])
Progression-Free Survival (PFS)
To evaluate progression-free survival
Time frame: Three years after last patient first dose
Overall Survival (OS)
The estimates of Kaplan-Meier
Time frame: Three years after last patient first dose
Duration of Response (DOR)
To evaluate duration of response
Time frame: Three years after last patient first dose
Objective response rate (ORR)
evaluated by IRC (PR + VGPR + CR + sCR)
Time frame: Three years after last patient first dose
Progression-free survival(PFS2)
PFS after further treatment followed by treatment with SVd/Vd
Time frame: Three years after last patient first dose
Time to remission(TTR)
To compare the efficacy of treatment with SVd and Vd
Time frame: Three years after last patient first dose
VGPR+CR+sCR
Proportion of subjects of VGPR + CR + sCR
Time frame: Three years after last patient first dose
Safety Endpoints
Incidence of any Grade ≥ 2 peripheral neuropathy events
Time frame: Three years after last patient first dose
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Hefei, Anhui, China
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Hefei, Anhui, China
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Guangzhou, Guangdong, China
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