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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: VELCADE Administered by subcutaneous injection; Drug: VELCADE Administered by intravenous infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722566

26866138 MMY 3021

Details and patient eligibility

About

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

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

1

Experimental group

Description:

VELCADE administered by subcutaneous injection

Treatment:

Drug: VELCADE Administered by subcutaneous injection

2

Active Comparator group

Description:

VELCADE administered by intravenous infusion

Treatment:

Drug: VELCADE Administered by intravenous infusion