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
← catalyst calendarNCT06952478 · readout in 452 d
Sponsored by Celltrion (industry) · 068270.KS — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
486estimated
Sites
1
Country
Taiwan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-12 | actual | When the study began enrolling |
| Primary completion | 2027-11-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-25 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Refractory or Relapsed Multiple Myeloma
Interventions
- Biological: CT-P44(Daratumumab)
- Biological: Darzalex Faspro(Daratumumab)
Primary outcomes
what the primary-completion date above is the date OFPK equivalence of CT-P44 and Darzalex Faspro
measured Week 0 ~ Week 24
Therapeutic equivalence of CT-P44 and Darzalex Faspro
measured Week 0 ~ Week 24
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