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
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: VELCADE Administered by subcutaneous injection
Drug: VELCADE Administered by intravenous infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.



Enrollment: 222
Study Start Date: July 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
VELCADE administered by subcutaneous injection
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
Active Comparator: 2
VELCADE administered by intravenous infusion
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722566

Locations
Belgium
UZ Brussel Department Medical Oncology Laarbeeklaan 101
Brussel, Belgium, 1090
France
Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU
NANTES Cedex 01, France, 44093
Germany
Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33
Münster, Germany, 48129
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00722566     History of Changes
Other Study ID Numbers: 26866138 MMY 3021
Study First Received: July 23, 2008
Results First Received: August 30, 2011
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014