Celltrion ((CONIF)) announced an update on their ongoing clinical study.
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Study Overview: The study titled 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 aims to evaluate the pharmacokinetics, efficacy, and safety of CT-P44 compared to Darzalex Faspro. This study is significant as it targets patients with refractory or relapsed multiple myeloma, potentially offering new treatment options.
Intervention/Treatment: The interventions being tested are CT-P44 and Darzalex Faspro, both administered subcutaneously at 1800 mg. These biological treatments are combined with Lenalidomide and Dexamethasone to treat patients until disease progression, unacceptable toxicity, or a specified cycle is reached.
Study Design: This interventional study uses a randomized, parallel assignment model with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are blinded. The primary purpose is treatment-focused, aiming to assess the effectiveness and safety of the interventions.
Study Timeline: The study began on August 12, 2025, with recruitment currently ongoing. The primary completion and estimated study completion dates are yet to be announced. The last update was submitted on the start date, August 12, 2025, indicating the study’s active status.
Market Implications: The ongoing study could significantly impact Celltrion’s stock performance, as positive results might enhance investor confidence and position the company favorably against competitors in the multiple myeloma treatment market. The study’s progress is crucial for stakeholders monitoring advancements in cancer therapies.
The study is currently ongoing, with further details available on the ClinicalTrials portal.
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