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

Phase 3

Conditions: multiple myeloma or M. Kahler
10035227
10018865

Registration Number: NL-OMON32310

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Measurable, secretory multiple myeloma defined as a serum monoclonal IgG of >10 g/L or a serum monoclonal IgA, IgD,or IgE >5 g/L, or urine M-protein of >200 mg/24 hr
- Relapse or progression of myeloma following prior systemic antineoplastic therapy. Relapse or progression is defined by any of the following: · Reappearance of measurable disease (as defined above) following CR
· >25% increase in serum or urine M-protein
· Development of new or worsening lytic bone disease
· New plasmacytomas or >50% increase in the longest dimension of an existing plasmacytoma
· Worsening hypercalcemia (corrected serum Ca >11.5 mg/dL [2.8 mmol/L]) due to multiple myeloma

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 >6 month treatment-free interval)
3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ³2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>The primary objective is to compare the overall response rate ORR (CR+PR),<br /><br>after 4 cycles, of subcutaneously (SC) administered VELCADE® to intravenously<br /><br>(IV) administered VELCADE® in patients with previously treated multiple myeloma</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives<br /><br>The secondary objectives are:<br /><br>· To determine the CR, nCR and VGPR rates after 4 cycles of single-agent<br /><br>VELCADE®, the ORR after 8 cycles including the effect of adding dexamethasone,<br /><br>the duration of response (DOR), time to disease progression (TTP),<br /><br>progression-free survival (PFS), 1-year survival, and time to response<br /><br>following VELCADE® treatment, administered either SC or IV<br /><br>· To evaluate the safety and tolerability of the 2 routes of administration,<br /><br>including the local tolerability of SC administration<br /><br>· To describe the plasma pharmacokinetics and pharmacodynamics (via whole blood<br /><br>20S proteasome inhibition assay) of SC administered VELCADE® as compared to IV<br /><br>administered VELCADE®</p><br>