A Double-Blind, Randomized, Active Controlled, Parallel-group, 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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518588-36-00

Acronym

CT-P44 3.1

Enrollment

Registered

2025-08-29

Start date

2025-12-24

Completion date

Unknown

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory or Relapsed Multiple Myeloma

Brief summary

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., 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.

Interventions

DRUGDaratumumab

DRUGDARATUMUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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., 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.	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026