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

Sponsor
Celltrion
Study ID
NCT06952478
Phase
PHASE3
Status
Recruiting
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Conditions

  • Refractory or Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT-P44(Daratumumab) — BIOLOGICAL
    CT-P44 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 26, whichever occurs first.
  • Darzalex Faspro(Daratumumab) — BIOLOGICAL
    Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 13, whichever occurs first.

Study Details

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

Key Dates

Start date
Aug 12, 2025
Status verified
Aug 2025
Primary completion
Nov 15, 2027
Completion
Jun 25, 2029

Study Design

Enrollment
486 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CT-P44
    CT-P44 1800mg SC (subcutaneous)
  • Active Comparator: Darzalex Faspro
    Darzalex Faspro 1800mg SC (subcutaneous)

Primary Outcome Measure

PK equivalence of CT-P44 and Darzalex Faspro [ Time Frame: Week 0 ~ Week 24 ]

Central Contacts