A study to compare Efficacy, Safety and How the Body Absorbs, Distributes, and Eliminates of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celltrion Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Dec 2025 → ongoing

Decision date (initial)

2025-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Bioequivalence, Pharmacokinetic, Safety

The primary objective of this study is to demonstrate the PK similarity of CT-P44 and Darzalex Faspro in the PK Group and therapeutic equivalence of CT-P44 and Darzalex Faspro in the Main Study Group. All patients in the PK Group and non-PK Group will be included in the Main Study Group. The PK equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of area under the concentration-time curve from Week 0 to Week 1 (AUCWeek0-1) and area under the concentration-time curve from Week 8 to Week 10 (AUCWeek8-10) of daratumumab in the PK set–PK Group at 1st dose, and PK set–PK Group up to 9th doses, respectively. The therapeutic equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of proportion of patients who will achieve 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.

Secondary objectives 5

1. [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.
2. [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.
3. [Main Study Group] 2. The secondary PK objective of this study is to evaluate the PK profile in terms of Ctrough of daratumumab.
4. [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.
5. [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.

Conditions and MedDRA coding

Refractory or Relapsed Multiple Myeloma

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female with 18 years of age or older.
2. Patient must have documented multiple myeloma (MM).
3. Patient must have a documented relapsed or refractory disease.
4. 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.
5. Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.
6. Patient must have received at least 1, but maximum 3 prior lines of therapy for MM.

Exclusion criteria 5

1. Patient has received daratumumab or any other drug specifically targeting CD38 previously.
2. 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) Discontinued due to any AEs related to prior lenalidomide treatment, or b) If, at any time point, the patient was refractory to any dose of lenalidomide.
3. Patient has received a prior treatment with one or more of the followings: a) Approved 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) Current or recent treatment (within 28 days before randomization or 5 half-lives, whichever is longer) with any other investigational medicinal product or device. c) Radiation therapy within 14 days of randomization. Patients must have recovered from all radiation-related toxicities. d) Plasmapheresis within 28 days of randomization. e) Live or live-attenuated vaccine, or all coronavirus disease-19 (COVID-19) vaccines within 14 days prior to randomization.
4. 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.
5. Patient has previously received an allogenic stem cell transplant regardless of timing.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celltrion Inc.

Sponsor organisation

Celltrion Inc.

Address

23 Academy-Ro, Yeonsu-Gu Yeonsu-Gu

City

Incheon

Postcode

22014

Country

Korea, Republic of

Scientific contact point

Organisation

Celltrion Inc.

Contact name

Clinical Planning

Public contact point

Organisation

Celltrion Inc.

Contact name

JoonSoo Ha

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications