A 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
Phase 3
Not yet recruiting
- Conditions
- Refractory or Relapsed Multiple Myeloma
- Interventions
- Biological: CT-P44(Daratumumab)Biological: Darzalex Faspro(Daratumumab)
- Registration Number
- NCT06952478
- Lead Sponsor
- Celltrion
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 486
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-P44 CT-P44(Daratumumab) CT-P44 1800mg SC (subcutaneous) Darzalex Faspro Darzalex Faspro(Daratumumab) Darzalex Faspro 1800mg SC (subcutaneous)
- Primary Outcome Measures
Name Time Method PK equivalence of CT-P44 and Darzalex Faspro Week 0 ~ Week 24 AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Therapeutic equivalence of CT-P44 and Darzalex Faspro Week 0 ~ Week 24 Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
- Secondary Outcome Measures
Name Time Method