TriangleNCT00722566 · CITED IN SOURCE DOCUMENTS
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2011-10-10
Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Male or female subjects 18 years or older 2. Diagnosis of multiple myeloma 3. 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 4. Relapse or progression of myeloma following prior systemic antineoplastic therapy. Exclusion Criteria: 1. Previous treatment with VELCADE 2. 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) 3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2 4. 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 5. Any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery) 6. 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- VELCADE administered by subcutaneous injection
- intervention Names
- Drug: VELCADE Administered by subcutaneous injection
- label
- 1
- type
- EXPERIMENTAL
- description
- VELCADE administered by intravenous infusion
- intervention Names
- Drug: VELCADE Administered by intravenous infusion
- label
- 2
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- 1
- description
- Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
- name
- VELCADE Administered by subcutaneous injection
- type
- DRUG
- arm Group Labels
- 2
- description
- Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
- name
- VELCADE Administered by intravenous infusion
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 222
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg
- measure
- Number of Patients With Overall Response (Complete Response + Partial Response)
- time Frame
- Over 4 cycles (prior to the addition of dexamethasone)
- secondary Outcomes
- description
- Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.
- measure
- Number of Patients With Complete Response
- time Frame
- Over 4 cycles (prior to the addition of dexamethasone)
Full study description
- 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.
Source references
- references
- citation
- Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Rekhtman G, Masliak Z, Robak P, Esseltine DL, Feng H, Deraedt W, van de Velde H, Arnulf B. Subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: subanalysis of patients with renal impairment in the phase III MMY-3021 study. Haematologica. 2015 May;100(5):e207-10. doi: 10.3324/haematol.2014.118182. Epub 2015 Jan 16. No abstract available.
- pmid
- 25596270
- type
- DERIVED
- citation
- Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M, Rekhtman G, Masliak Z, Robak T, Shubina A, Arnulf B, Kropff M, Cavet J, Esseltine DL, Feng H, Girgis S, van de Velde H, Deraedt W, Harousseau JL. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011 May;12(5):431-40. doi: 10.1016/S1470-2045(11)70081-X. Epub 2011 Apr 18.
- pmid
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- type
- DERIVED
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Preserved source evidence · Not medical advice