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
This is a prospective, multi-centre, randomized (the study drug is assigned by chance),
controlled, open-label (all people involved in the study know the identity of the assigned
drug), parallel (each group of patients will be treated at the same time) group phase III
study to determine the efficacy of the standard therapy of bortezomib and low dose
dexamethasone in combination with or without continuous low dose oral cyclophosphamide for
primary refractory or relapsed myeloma patients (1st - 3rd relapse). The study will consist
of screening period, which may last from day -14 until day -1 before application of the
first dose of bortezomib (on cycle 1, day 1), treatment phase begins on cycle 1 day 1 and
continues until completion or discontinuation of all study drugs and follow-up phase. All
patients will be followed up after end of treatment regardless of their response. Eligible
patients will be randomized in 1:1 ratio to receive either treatment arms (Group A:
receiving bortezomib plus dexamethasone or Group B receiving bortezomib plus dexamethasone
plus cyclophosphamide). Patients will receive up to eight 3-weeks treatment cycles, unless
they experience either unacceptable toxicity or if the patients request to withdraw from the
study. The maximum number of cycles is dependent on patient response and investigator's
discretion. It is recommended that patients with a confirmed complete response (CR) receive
2 additional cycles beyond a confirmation. Patients who do not achieve a CR but a partial
response will receive a total of 8 cycles. For patients achieving stable disease it is
within the investigator's discretion to continue study treatment beyond 6 cycles, after
discussion with the sponsor. After completion of treatment the patients will be followed up
every 12 weeks for up to 72 weeks. If the study is still ongoing a further follow up period
will be done every 26 weeks until study end, or until the patient reaches progressive
disease or start of alternative anti-myeloma therapy, if earlier. In case progressive
disease (PD) has already been established during the treatment phase the patients will not
enter the follow-up phase. In case of PD or start of alternative anti-myeloma treatment
before the end of study the follow-up phase will be discontinued for the patient but the
date of death of the patient will be documented (if applicable) before the end of study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression (TTP)
The TTP is the time from randomization to progressive disease, death or drop out without progression.
Up to progressive disease (PD) or death
No
Janssen-Cilag G.m.b.H, Germany Clinical Trial
Study Director
Janssen-Cilag G.m.b.H
Germany: Federal Institute for Drugs and Medical Devices
CR015247
NCT00813150
January 2009
January 2013
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