Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone With or Without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma
Phase of Trial: Phase III
Latest Information Update: 01 Nov 2017
At a glance
- Drugs Bortezomib (Primary) ; Dexamethasone (Primary) ; Cyclophosphamide
- Indications Multiple myeloma
- Focus Registrational; Therapeutic Use
- Sponsors Janssen-Cilag
- 01 Nov 2017 Status changed to discontinued.
- 01 Nov 2017 Primary endpoint (Time to Progression of Disease) has not been met as per the results published in the Annals of Hematology
- 01 Nov 2017 Due to a lack of recruitment, the planned sample size of 270 patients was not reached and enrollment was stopped prematurely as a result of a joint decision of the sponsor and coordinating investigator; the study was therefore underpowered with regard to the primary aim of the study.