Clinical trial designs for multiple myeloma.

摘要: The development of new anti-myeloma agents with different mechanisms action from conventional chemotherapy has necessitated a look at clinical trial design. We discuss design issues for cytostatic phase I, II, and III trials pertaining to myeloma. success I cytotoxic is predicated on the dose toxicity curve being strictly monotone. With agents, however, shape not necessarily monotone, traditional designs may no longer be applicable. distinction between also highlights importance thinking endpoints other than tumor response (or shrinkage) whose depends more keeping stable. appropriateness in II myeloma discussed. goal typically twofold: determine efficacy agent all patients subset certain biomarker. present that can address both aims.