DARATUMUMAB for Relapsed/refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Male or female with 18 years of age or older."}
• {"criterion_text":"- Patient must have documented multiple myeloma (MM)."}
• {"criterion_text":"- Patient must have a documented relapsed or refractory disease."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy."}
• {"criterion_text":"- Patient must have received at least 1, but maximum 3 prior lines of therapy for MM."}

Exclusion criteria

• {"criterion_text":"- Patient has received daratumumab or any other drug specifically targeting CD38 previously."}
• {"criterion_text":"- Patient’s disease shows evidence of refractoriness or intolerance to lenalidomide. If previously treated with a lenalidomide-containing regimen, the patient is excluded if he or she: a)\tDiscontinued due to any AEs related to prior lenalidomide treatment, or b)\tIf, at any time point, the patient was refractory to any dose of lenalidomide."}
• {"criterion_text":"- Patient has received a prior treatment with one or more of the followings: a)\tApproved anti-myeloma agents within 14 days or 5 PK half-lives of the treatment, whichever is longer, before the date of randomization. Note. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days) before Day 1 of Cycle 1. b)\tCurrent or recent treatment (within 28 days before randomization or 5 half-lives, whichever is longer) with any other investigational medicinal product or device. c)\tRadiation therapy within 14 days of randomization. Patients must have recovered from all radiation-related toxicities. d)\tPlasmapheresis within 28 days of randomization. e)\tLive or live-attenuated vaccine, or all coronavirus disease-19 (COVID-19) vaccines within 14 days prior to randomization."}
• {"criterion_text":"- Patient has received ASCT within 12 weeks before the date of randomization, or the patient’s immune system has not sufficiently recovered after ASCT under the investigator's judgment."}
• {"criterion_text":"- Patient has previously received an allogenic stem cell transplant regardless of timing."}

Primary endpoints

• {"endpoint_text":"- AUCWeek0-1 and AUCWeek8-10 of daratumumab in the PK set–PK Group at 1st dose, and PK set–PK Group up to 9th doses, respectively.","definition_or_measurement_approach":"Area under the concentration-time curve from Week 0 to Week 1 (AUCWeek0-1) and from Week 8 to Week 10 (AUCWeek8-10) of daratumumab measured in the PK set–PK Group at 1st dose and up to 9th doses, respectively."}
• {"endpoint_text":"- Very good partial response (VGPR) or better based on the confirmed best overall response (BOR) up to Week 24 from the last patient’s randomization according to the IMWG criteria in the intent-to-treat (ITT) set.","definition_or_measurement_approach":"Proportion of patients achieving VGPR or better (based on confirmed BOR) up to Week 24 from the last patient's randomization, assessed according to IMWG criteria in the ITT population."}

Secondary endpoints

• {"endpoint_text":"- [PK Group] 1. The secondary PK objective of this study is to evaluate the PK profudyile in terms of Cmax at the 1st and 9th doses of daratumumab.","definition_or_measurement_approach":"Evaluate Cmax of daratumumab at 1st and 9th doses in PK Group."}
• {"endpoint_text":"- [Main Study Group] 1. The secondary efficacy objective of this study is to evaluate additional efficacy profiles of CT-P44 and Darzalex Faspro in terms of proportion of patients who will achieve VGPR or better (sCR + CR + VGPR), overall response rate (ORR), MRD negativity rate, time-to-event analysis including PFS, TTP, DoR, and OS, and EORTC QLQ-C30.","definition_or_measurement_approach":"Assess proportions achieving VGPR or better, ORR, MRD negativity rate, and time-to-event endpoints (PFS, TTP, DoR, OS); patient-reported outcomes via EORTC QLQ-C30."}
• {"endpoint_text":"- [Main Study Group] 2. The secondary PK objective of this study is to evaluate the PK profile in terms of Ctrough of daratumumab.","definition_or_measurement_approach":"Measure Ctrough (trough concentration) of daratumumab in the Main Study Group."}
• {"endpoint_text":"- [Main Study Group] 3. The secondary immunogenicity objective of this study is to evaluate immunogenicity profiles in terms of incidence of ADA and neutralizing antibody and titer of ADA of daratumumab and rHuPH20 for CT-P44 and Darzalex Faspro treatment groups.","definition_or_measurement_approach":"Assess incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies for daratumumab and rHuPH20 in treatment groups."}
• {"endpoint_text":"- [Main Study Group] 4. The secondary safety objective of this study is to evaluate safety profiles in terms of AEs (including SAEs), AESIs, vital signs and weight, ECG, Physical examination findings, serum or urine pregnancy testing, clinical laboratory (hematology, chemistry and urinalysis), ECOG PS, prior and concomitant medications.","definition_or_measurement_approach":"Collect and summarize adverse events (AEs/SAEs/AESIs), vital signs, weight, ECGs, physical exam findings, pregnancy tests, clinical labs, ECOG performance status, and concomitant medications."}

Spain

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

04-05-2026

Processing Time Days

290

Number Of Sites

3

Number Of Participants

21

Poland

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

265

Number Of Sites

2

Number Of Participants

21

Primary sponsor

Full Name

Celltrion Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Korea, Republic of