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An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

Phase 3
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Overall Response (Complete Response + Partial Response)

Outcome 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

Outcome Time Frame:

Over 4 cycles (prior to the addition of dexamethasone)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Food and Drug Administration

Study ID:

26866138 MMY 3021



Start Date:

July 2008

Completion Date:

September 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell