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RecruitingPhase 3NCT06952478

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

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

Sponsor

Celltrion

Enrollment

486 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Refractory or Relapsed Multiple Myeloma

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Male or female with 18 years of age or older.
  • Patient must have documented multiple myeloma (MM) according to IMWG criteria
  • Patient must have a documented relapsed or refractory disease.
  • Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
  • Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.

Exclusion Criteria3

  • Patient has received daratumumab or any other drug specifically targeting CD38 previously.
  • Patient's disease shows evidence of refractoriness or intolerance to lenalidomide.
  • Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Interventions

BIOLOGICALCT-P44(Daratumumab)

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.

BIOLOGICALDarzalex Faspro(Daratumumab)

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.

Locations(1)

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

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NCT06952478