Clinical advances in hematology & oncology : H&O
The most recent articles from:
Clin Adv Hematol Oncol
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The development of new anti-myeloma agents with different mechanisms of action from conventional chemotherapy has necessitated a new look at clinical trial design. We discuss design issues for cytostatic agents for phase I, II, and III clinical trials pertaining to myeloma. The success of phase I trials with cytotoxic agents is predicated on the dose toxicity curve being strictly monotone. ⋯ The appropriateness of different endpoints in phase II myeloma trials is discussed. The goal of phase III clinical trials for cytostatic agents is typically twofold: to determine efficacy of the new agent for all patients and for the subset of patients with a certain biomarker. We present different trial designs that can address both aims.