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

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: VELCADE Administered by subcutaneous injection; Drug: VELCADE Administered by intravenous infusion

• Registration Number: NCT00722566
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Results First Submitted: 2011-08-30
• Results First Submitted QC: 2011-08-30
• Status Verified: 2011-10
• Results First Posted: 2011-10-04
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	VELCADE Administered by subcutaneous injection	VELCADE administered by subcutaneous injection
2	VELCADE Administered by intravenous infusion	VELCADE administered by intravenous infusion

Primary Outcome Measures

Name	Time	Method
Number of Patients With Overall Response (Complete Response + Partial Response)	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Complete Response	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.

Trial Locations

Locations (3)

UZ Brussel Department Medical Oncology Laarbeeklaan 101; 🇧🇪 Brussel, Belgium

Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33; 🇩🇪 Münster, Germany

Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU; 🇫🇷 NANTES Cedex 01, France