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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 3
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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.

Inclusion Criteria:

- Previously diagnosed with multiple myeloma

- Primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of

- Karnofsky performance status must be equal to 60 percentage (ie, better or equal
performance than requiring some help and taking care of most personal requirements)

- Has life expectancy estimated at screening must be of at least 6 months

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Not received more than three previous lines of therapy for multiple myeloma

- Not received nitrosoureas or any other chemotherapy or immunotherapy or antibody
therapy for multiple myeloma within 6 to 8 weeks before enrolment. Plasmapheresis
must not be applied within 2 weeks before enrolment

- Patients with peripheral neuropathy or neuropathic pain of Grade 2 or greater

- Patients with poorly controlled cardio vascular, vascular, pulmonary,
gastro-intestinal, endocrine, neurological, psychiatric, hepatic, renal or metabolic
diseases or hematological disorders

- Not have oligosecretory or non-secretory multiple myeloma

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression (TTP)

Outcome Description:

The TTP is the time from randomization to progressive disease, death or drop out without progression.

Outcome Time Frame:

Up to progressive disease (PD) or death

Safety Issue:


Principal Investigator

Janssen-Cilag G.m.b.H, Germany Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag G.m.b.H


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2009

Completion Date:

January 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Bortezomib
  • Dexamethasone
  • Cyclophosphamide
  • Oncology
  • Multiple Myeloma
  • Neoplasms, Plasma Cell