Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
This study is currently recruiting participants.
Verified by Millennium Pharmaceuticals, Inc., March 2009
First Received: July 23, 2008   Last Updated: March 23, 2009   History of Changes
Sponsors and Collaborators: Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00722566
  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 III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

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

Primary Outcome Measures:
  • Overall response rate [ Time Frame: After 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response, near complete response, and very good partial response [ Time Frame: After 4 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: July 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Active Comparator
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 based on the standard criteria.
  3. Relapse or progression of myeloma following prior systemic antineoplastic therapy.
  4. Karnofsky performance status greater than or equal to 70%
  5. Women who are not post-menopausal or surgically sterile must have a negative pregnancy test and agree to use an acceptable method of birth control during the study until 30 days after the last dose of study drug.
  6. Men must agree to not father a child and agree to use a latex condom during treatment and for 30 days after the last dose of study drug, even if they have had a successful vasectomy, if their partners are of childbearing potential.

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

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-866-835-2233 medical@mlnm.com

Locations
United States, Florida
Pasco Hernando Oncology Recruiting
Port Richey, Florida, United States, 34562
Contact: Kumar Kapisthalam, M.D.            
United States, New Jersey
Hackensach University Medical Center Recruiting
Hackensach, New Jersey, United States, 07601
Contact: David Siegel, M.D.            
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

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development ( Clinical Research Monitor )
Study ID Numbers: 26866138 MMY 3021
Study First Received: July 23, 2008
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00722566     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Protease Inhibitors
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

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

ClinicalTrials.gov processed this record on May 07, 2009