Status:
COMPLETED
Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved...
Detailed Description
It has been shown that quality of response corresponds with clinical benefit. Stable disease is not regarded as a satisfactory result of therapy for relapsed and refractory multiple myeloma. However, ...
Eligibility Criteria
Inclusion
- Patient has relapsed/progressed or is refractory for multiple myeloma following 1 previous line of therapy
- Measurable secretory multiple myeloma: measurable disease for secretory multiple myeloma is defined by at least one of the following measurements: serum monoclonal protein greater than or equal to 1 g/dl (\> 10 gm/l) \[10g/l\], urine M-protein of ≥200 mg/24 hours
- Patient has a Karnofsky performance status of ≥ 60
- Patient has a life expectancy estimated at screening of at least 6 months
- Patient fulfills defined pretreatment laboratory requirements at and within 14 days before baseline
Exclusion
- Patient received more than 1 previous line of therapy for multiple myeloma
- Patient has known allergy or hypersensitivity to bortezomib, Dexamethasone and/or Cyclophosphamide and/or Lenalidomide or any of the constituent compounds such as boron, mannitol, or lactose
- Patient has oligosecretory or non-secretory multiple myeloma
- Patient received nitrosoureas or any other chemotherapy (including thalidomide), clarithromycin, interferon within 6 weeks before enrolment. Note: subjects can have received thalidomide or interferon as maintenance therapy, according to local standard of care
- Patient received corticosteroids (\> 10 mg/day prednisone or equivalent) within 3 weeks before enrolment. Note: subjects can have received steroids (dexamethasone or equivalent) as maintenance therapy according to local standard of care. In addition, subjects can have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT00908232
Start Date
May 1 2008
End Date
August 1 2011
Last Update
January 15 2015
Active Locations (42)
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1
Bordeaux, France
2
Le Mans, France
3
Lille, France
4
Tours, France