An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
SCIO-469
+ SCIO-469 and bortezomib
Blood Protein Disorders+11
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.62 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Life expectancy more than three months * diagnosed with multiple myeloma (MM) * relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy * Karnofsky performance status = 60 * no electrocardiographic evidence of acute ischemia or new conduction system abnormalities * no history of myocardial infarction within last 6 months * serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN) * total serum bilirubin = 2X ULN * Calculated or measured creatinine clearance \>30 mL/min * platelet count = 30 x 10(9)/L * hemoglobin concentration = 8 g/dL * white blood cell count = 2.0 x 10(9)/L Exclusion Criteria: * Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes) * major surgery within four weeks of enrollment * severe elevated serum calcium * heart failure * receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents * receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment * known allergies to agents used in bortezomib (e.g., boron or mannitol) * poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives