Status:
COMPLETED
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.
Eligibility Criteria
Inclusion
- Male or female subjects 18 years or older
- Diagnosis of multiple myeloma
- Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr
- Relapse or progression of myeloma following prior systemic antineoplastic therapy.
Exclusion
- Previous treatment with VELCADE
- More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
- Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
- Any of the following within 3 weeks prior to randomization:
- antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
- Any of the following within 2 weeks prior to randomization:
- radiation therapy, major surgery (kyphoplasty is not considered major surgery)
- Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00722566
Start Date
July 1 2008
End Date
September 1 2010
Last Update
October 10 2011
Active Locations (3)
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1
UZ Brussel Department Medical Oncology Laarbeeklaan 101
Brussels, Belgium, 1090
2
Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU
Nantes, France, 44093
3
Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33
Münster, Germany, 48129