Multiple Myeloma Clinical Trial
Official title:
Multi-center, Open-label, Dose-escalating Phase I/II Trial of GS-9219 Administered Once Every Three Weeks Intravenously to Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma or Multiple Myeloma
Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult
patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the
study in sequential dose cohorts.
Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and
may receive a total of six treatment cycles based on toxicities and response. Patients who
demonstrate disease progression will be discontinued from the study. Patients who, at the
completion of six treatment cycles, tolerate treatment and show evidence of disease control
(response or stabilization) will be eligible to continue receiving treatment at the same
dose.
The primary objective of this study is as follows:
To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via
IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a
total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia
(CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).
The secondary objectives of this study are as follows:
To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient
population.
To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response.
Progression-free Survival and Overall Survival will be assessed if applicable.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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