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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722566
• Other study ID #: 26866138 MMY 3021
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2008
• Last updated: October 6, 2011
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel Department Medical Oncology Laarbeeklaan 101	Brussel
France	Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU	NANTES Cedex 01
Germany	Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33	Münster

Sponsors (2)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Overall Response (Complete Response + Partial Response)	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	Over 4 cycles (prior to the addition of dexamethasone)	No
Secondary	Number of Patients With Complete Response	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.	Over 4 cycles (prior to the addition of dexamethasone)	No