Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma
Status:
Terminated
Trial end date:
2016-12-31
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to estimate the overall response rate (ORR), defined as
partial response (PR) or better at any time during induction therapy. The success of the
therapy will be determined by ORR with strong consideration given to the secondary endpoints
of tolerability, duration of response, and quality of life (QOL).
All patients will be treated with the same experimental regimen. Several novel features are
being explored: the substitution of cyclophosphamide for melphalan; once weekly AND
subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating
bortezomib and lenalidomide in maintenance.
The investigators hypothesize that this regimen will prove to be tolerable and effective in
inducing and maintaining remission in a patient population that is historically very
difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer
comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies
like autologous stem-cell transplantation (ASCT). In short, the investigators view this as
the "Multiple Myeloma trial for non-trial candidates."
Phase:
Phase 2
Details
Lead Sponsor:
Duke University
Collaborators:
Duke Cancer Institute Millennium Pharmaceuticals, Inc.