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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
    • 01 Nov 2017 Results (Data cut off, 10 January 2013) published in the Annals of Hematology
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