A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722566
First received: July 23, 2008
Last updated: October 6, 2011
Last verified: October 2011

July 23, 2008
October 6, 2011
July 2008
August 2010   (final data collection date for primary outcome measure)
Number of Patients With Overall Response (Complete Response + Partial Response) [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]

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

Overall response rate [ Time Frame: After 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00722566 on ClinicalTrials.gov Archive Site
Number of Patients With Complete Response [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]

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.

Complete response, near complete response, and very good partial response [ Time Frame: After 4 cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: VELCADE Administered by subcutaneous injection
    Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
  • Drug: VELCADE Administered by intravenous infusion
    Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
  • Experimental: 1
    VELCADE administered by subcutaneous injection
    Intervention: Drug: VELCADE Administered by subcutaneous injection
  • Active Comparator: 2
    VELCADE administered by intravenous infusion
    Intervention: Drug: VELCADE Administered by intravenous infusion
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. Erratum in: Lancet Oncol. 2011 Jun;12(6):522.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany
 
NCT00722566
26866138 MMY 3021
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Medical Monitor Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Millennium Pharmaceuticals, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP