WHO ICTRP trial

A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate…

EUCTR2007-001462-33-FR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2007-001462-33-FR
Public title A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of VELCADE® in combination with Dexamethasone or VELCADE® in combination with Dexamethasone and Cyclophosphamide or VELCADE® in combination with Dexamethasone and Lenalidomide in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed / progressed after Primary Therapy for Multiple Myeloma and have achieved stable disease after 4 cycles of VELCADE®/Dexamethasone therapy
Scientific title A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of VELCADE® in combination with Dexamethasone or VELCADE® in combination with Dexamethasone and Cyclophosphamide or VELCADE® in combination with Dexamethasone and Lenalidomide in Subjects with…
Primary sponsor Janssen-Cilag International N.V.
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 France;Hungary;Greece;Spain;Lithuania;Germany;United Kingdom
Conditions multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Interventions Trade Name: Velcade Product Name: Velcade Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib CAS Number: 179324-69-7 Other descriptive name: BORTEZOMIB Concentration unit: mg milligram(s) Concentration…
Registration date Oct 31, 2007
Target size 190
Secondary IDs 26866138-MMY-2045
Registry page clinicaltrialsregister.eu

At a glance

  • Yes Results available

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

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