Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Study of Carfilzomib as a Replacement for Multiple Myeloma Patients Failing Bortezomib-containing Regimens
This is a phase I/II multicenter, open label, nonrandomized study for patients with Multiple
Myeloma (MM) who will receive treatment with carfilzomib in place of bortezomib using the
same bortezomib-containing combination regimen to which a MM patient has progressed while
receiving. This study will enroll 45 patients total. These patients will be resistant to
bortezomib as demonstrated by progressive disease while on bortezomib or have relapsed within
12 weeks of the last dose of bortezomib in a combination regimen. Patients will be
sub-divided into 2 groups in this study, treatments containing (Group A) or not containing
immunomodulatory drugs (IMiDs) (Group B). Thirty patient will be enrolled into Group A and 15
patients into Group B for a total of 45 patients. Patients must have received 4 doses of a
minimum of 1.0 mg/m^2 of bortezomib in no more than 4 weeks per cycle. Patients must have
received at least one cycle meeting this definition and have shown progressive disease to be
considered eligible. Patients who have been refractory to or relapsed within 12 weeks of the
last dose of bortezomib in their most recent bortezomib-containing regimen that does not
include either thalidomide or lenalidomide are eligible regardless of when patients received
that regimen, as long as they meet the above criteria.
Carfilzomib will subsequently replace bortezomib using the patient's most recent
bortezomib-containing regimen to which the patient progressed while receiving. Patients will
be eligible if they progressed from bortezomib with an alkylating agent (melphalan or
cyclophosphamide), an anthracycline (doxorubicin or pegylated liposomal doxorubicin) and/or a
glucocorticosteroid (prednisone, dexamethasone or medrol)and IMiD (thalidomide or
lenalidomide). The study will consist of a screening period, followed by up to eight open
label treatment cycles, a final assessment to occur 28 days after the end of the last
treatment cycle, a follow-up period and maintenance cycles of single agent carfilzomib.
Patient who complete the combination treatment period without progressive disease will be
eligible for maintenance therapy with single-agent carfilzomib. During maintenance therapy
carfilzomib will be administered at the same dose given during the last cycle of combination
treatment.
n/a
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