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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelltrion

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CT-P44(Daratumumab)
  • Darzalex Faspro(Daratumumab)

Treatment groups

486 Participants
are divided into 2 treatment groups

Sponsors and collaborators