NCT06952478RecruitingPhase 3
A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Celltrion
- Enrollment
- 486
- Locations
- 1
- Primary Endpoint
- PK equivalence of CT-P44 and Darzalex Faspro
Study Overview
Brief Summary
This study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CT-P44
Experimental
CT-P44 1800mg SC (subcutaneous)
Intervention: CT-P44(Daratumumab) (Biological)
Darzalex Faspro
Active Comparator
Darzalex Faspro 1800mg SC (subcutaneous)
Intervention: Darzalex Faspro(Daratumumab) (Biological)
Outcomes
Primary Outcomes
PK equivalence of CT-P44 and Darzalex Faspro
Time Frame: Week 0 ~ Week 24
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Therapeutic equivalence of CT-P44 and Darzalex Faspro
Time Frame: Week 0 ~ Week 24
Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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