The primary objective is to compare the overall response rate ORR(CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE tointravenously (IV) administered VELCADE in patients with previouslytreated multiple myeloma.The secondary…
ID
Source
Brief title
Condition
- Plasma cell neoplasms
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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®
Background summary
SC administration of VELCADE® will provide physicians with greater prescribing
options to meet their patients* needs, especially in patients with poor venous
access. This dosing alternative would eliminate the need for repeated IV access
or for insertion of long-term central venous assess devices, leading to
improved convenience for patients and physicians.
Study 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.
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
Study design
This will be a randomized, open-label, international, multi-center, phase 3
study in which subjects are randomized to receive VELCADE® administered by SC
injection or IV infusion. The study consists of 3 phases: a screening phase, an
open-label treatment phase, and a post-treatment follow-up phase. The study
population will consist of adults diagnosed with multiple myeloma, who have
received 1-3 prior lines of therapy and have measurable disease and evidence of
disease progression since their last prior therapy. Approximately 192 subjects
will be randomly assigned to 1 of 2 treatment groups in a 2:1 ratio (SC:IV).
Intervention
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 administration during 8 cycles (if indicated and
discussed, this can be prolonged with two additional cycles).
Study burden and risks
These can be compared to already known risks to Velcade. For Subcutaneous
administration, skin irritation can occur.
Dr. Paul Janssenweg 150
5026 RH, Tilburg
Nederland
Dr. Paul Janssenweg 150
5026 RH, Tilburg
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000952-28-NL |
| CCMO | NL22597.018.08 |