Trials / Not Yet Recruiting
Not Yet RecruitingNCT06742138
To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma
A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase III Clinical Study to Evaluate QL2109/ DARZALEX FASPRO® in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 284 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with pomalidomide + QL2109 + dexamethasone compared with pomalidomide + DARZALEX FASPRO® + dexamethasone in the participants with relapsed or refractory Multiple Myeloma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2024-12-19
- Last updated
- 2024-12-19
Source: ClinicalTrials.gov record NCT06742138. Inclusion in this directory is not an endorsement.