Finding studies
Finding studies
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Lead
Boston Medical Center
STUDY OBJECTIVES Primary objective: • Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma. Secondary objectives: * Characterize the safety and tolerability of UHDD as monotherapy in patients with relapsed multiple myeloma. * Determine the progression free survival amongst responders. * Determine the subset of patients in whom UHDD can be used as monotherapy for treatment of relapsed multiple myeloma STUDY ENDPOINTS Primary endpoint: To determine the anti-tumor activity of UHDD as monotherapy in patients with relapsed multiple myeloma as measured by the International Myeloma Working Group (IMWG) response criteria: * Change from baseline in M protein component. * Objective response rate (complete response \[CR\] + partial response \[PR\]) assessed according to IMWG response criteria. * Disease control rate (CR+PR+stable disease \[SD\]). Secondary endpoints: * Safety and tolerability of UHDD * Progression free survival. * Characteristics of patients responding to UHDD.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
