A Dose Escalation of Zarnestra (R115777) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma
In Phase I, patients will receive intravenous PS-341 (Velcade) and 3 different dose levels
of oral R115777 (Zarnestra). Dose Limiting Toxicity (DLT) will be determined over a period
of one cycle and dose escalation to the next level will not occur until all patients
projected at each level complete one cycle of therapy. Once DLT is determined, patients in
Phase I and all patients enrolled for the phase II component will be treated at the maximum
tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue beyond 8
cycles if there is evidence of continued response. The study regimen will consist of two
weeks of treatment followed by one week off for a total cycle duration of three weeks. If
disease stabilization occurs (noted on 2 consecutive cycles) after the standard 8 cycles are
given, treatment will be discontinued.
Patients are to be monitored for adverse events throughout the treatment phases and for a
minimum of 30 days after their last dose of drugs. Follow up will include history and
physical exam with laboratory evaluation at least every 3 months. Laboratories will include
CMP, CBC, SPEP, UPEP, and quantitative immunoglobulins. A skeletal survey will be performed
at least every 6 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity (DLT)
Determine the dose limiting toxicity at 3 weeks post treatment
Average of 6 months
Melissa Alsina, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
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