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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32310

Enrollment

Registered

2008-08-04

Start date

2008-06-30

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma or M. Kahler

Interventions

One group will receive Velcade as IV injection twice a week during two weeks, the other group will receive this medication as SC injection, followed by one week without study medication administrati

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary Objective The primary objective is to compare the overall response rate ORR (CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE® to intravenously (IV) administered VELCADE® in patients with previously treated multiple myeloma	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)