WHO ICTRP trial

Clinical Trial conduct to investigate if Daratumumab therapy for multiple…

EUCTR2017-003253-41-PL · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-003253-41-PL
Public title Clinical Trial conduct to investigate if Daratumumab therapy for multiple myeloma patients with minimal residual disease (MRD) reappearance or biochemical relapse is effective in preventive therapy.
Scientific title PRE-emptive DAratumumab Therapy Of minimal Residual disease reappearance or biochemical relapse in multiple myeloma (PREDATOR). - PREDATOR
Primary sponsor Polish Myeloma Consortium
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Poland
Conditions Multiple Myeloma and Minimal Residual Disease MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Trade Name: Darzalex® Product Name: Daratumumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DARATUMUMAB CAS Number: 945721-28-8 Other descriptive name: Daratumumab Concentration unit: mg/ml…
Registration date Jun 8, 2018
Target size 274
Secondary IDs PMC008
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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