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

Celltrion Healthcare

Status and phase: Enrolling; Phase 3

Conditions: Refractory or Relapsed Multiple Myeloma

Treatments: Biological: Darzalex Faspro(Daratumumab); Biological: CT-P44(Daratumumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06952478

2024-518588-36-00 (EU Trial (CTIS) Number)

CT-P44 3.1

Details and patient eligibility

About

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

Enrollment: 486 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

[Main Inclusion Criteria]

• 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.

[Main Exclusion Criteria]

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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486 participants in 2 patient groups

CT-P44

Experimental group

Description:

CT-P44 1800mg SC (subcutaneous)

Treatment:

Biological: CT-P44(Daratumumab)

Darzalex Faspro

Active Comparator group

Description:

Darzalex Faspro 1800mg SC (subcutaneous)

Treatment:

Biological: Darzalex Faspro(Daratumumab)