Status:
COMPLETED
Study of Bortezomib and Dexamethasone With or Without Cyclophosphamide in Patients With Relapsed or Not Controllable Multiple Myeloma
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare bortezomib, dexamethasone and cyclophosphamide to bortezomib and dexamethasone alone for primary refractory or relapsed multiple myeloma.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Previously diagnosed with multiple myeloma
- Primary refractory multiple myeloma or relapsed following 1 to 3 previous lines of therapy
- 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
- 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 intensity
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00813150
Start Date
January 1 2009
End Date
January 1 2013
Last Update
August 15 2014
Active Locations (40)
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1
Augsburg, Germany
2
Berlin, Germany
3
Bielefeld, Germany
4
Bremerhaven, Germany