To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Multiple Myeloma
Interventions
DRUG

QL2109

QL2109 will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.

DRUG

Pomalidomide

Intervention Description:Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle

DRUG

Dexamethasone

Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle

DRUG

DARZALEX FASPRO®

DARZALEX FASPRO® will be given 1800 mg subcutaneously at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY