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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722566
First Posted: July 25, 2008
Last Update Posted: October 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
July 23, 2008
July 25, 2008
August 30, 2011
October 4, 2011
October 10, 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) ]

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) ]
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) ]

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 ]
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: None (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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany
United States
 
NCT00722566
26866138 MMY 3021
No
Not Provided
Not Provided
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