Phase 3
N=222
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00722566 ↗Enrolled (actual)
222
Serious AEs
35.8%
Results posted
Oct 2011
Primary outcome: Primary: Number of Patients With Overall Response (Complete Response + Partial Response) — 61; 31 Participants — p=0.00201
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VELCADE Administered by subcutaneous injection (Drug); VELCADE Administered by intravenous infusion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Overall Response (Complete Response + Partial Response) |
61; 31 | 0.00201 sig |
| SECONDARY Number of Patients With Complete Response |
9; 6 | — |
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 Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00722566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.