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

NCT06952478 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CT-P44 3.12024-518588-36-00
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory or Relapsed Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• PK equivalence of CT-P44 and Darzalex Faspro

  AUCWeek0-1 and AUCWeek8-10 of daratumumab.

  Week 0 ~ Week 24

• 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.

  Week 0 ~ Week 24

Study Arms (2)

CT-P44

EXPERIMENTAL

CT-P44 1800mg SC (subcutaneous)

Biological: CT-P44(Daratumumab)

Darzalex Faspro

ACTIVE COMPARATOR

Darzalex Faspro 1800mg SC (subcutaneous)

Biological: Darzalex Faspro(Daratumumab)

Interventions

CT-P44(Daratumumab) BIOLOGICAL

CT-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.

CT-P44

Darzalex Faspro(Daratumumab) BIOLOGICAL

Darzalex 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.

Darzalex Faspro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

JoonSoo Ha

CONTACT

+82 32 850 5727; joonsoo.ha@celltrion.com

NaRae Ryu

CONTACT

+82 32 850 5731; narae.ryu@celltrion.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 1, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): June 25, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TW (1)