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
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 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.
Parallel
CT-P44(Daratumumab)
Biological/VaccineCT-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/VaccineDarzalex 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.
PK equivalence of CT-P44 and Darzalex Faspro
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Therapeutic equivalence of CT-P44 and Darzalex Faspro
Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR.
