Subcutaneous vs Intravenous VELCADE® in multiple myeloma
Research type
Research Study
Full title
An Open-Label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple Myeloma
IRAS ID
11011
Contact name
Jim Cavet
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2008-000952-28
Clinicaltrials.gov Identifier
Research summary
Standard front-line treatment for patients with multiple myeloma consists of either conventional chemotherapy or initial chemotherapy followed by high dose chemotherapy combined with stem cell transplant. At relapse, patients most commonly receive novel agents, such as VELCADE (bortezomib) for injection, lenalidomide, thalidomide, or combinations including these agents. This study is researching a new way of administering VELCADE, by injection under the skin (subcutaneously).The study will enrol adults 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 216 subjects will be assigned (at random) to 1 of 2 treatment groups (subcutaneous or intravenous VELCADE) in a 2:1 ratio. However, the study will be "open" - both investigators and subjects will both know to which group they have been assigned.Participation in genetic research is optional. If, after 4 cycles of therapy, a subject has no change or only a partial response and their disease has not progressed, an additional 4 cycles of VELCADE will be given.Subjects with progressive disease will be withdrawn from treatment at the time that progression is confirmed. Subjects who withdraw from treatment for reasons other than disease progression will continue to have assessments performed for the duration of the treatment phase. In the follow-up phase, subjects will be assessed every 8 weeks until progressive disease is recorded. After this point, subjects will be assessed every 12 weeks for survival and subsequent therapies. Follow-up will continue until the study ends (1 year after the last subject is randomized). Subjects at some hospitals will have additional blood samples drawn at during and after Day 11 of Cycle 1, for analysis of the way VELCADE is handled in the blood and its affect on the body.
REC name
London - Hampstead Research Ethics Committee
REC reference
08/H0720/173
Date of REC Opinion
15 Jan 2009
REC opinion
Further Information Favourable Opinion