Clinical trial · Interventional
Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
NCT00087867CI-TRIAL-00004031completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCIO-469 | Drug | — | UNRESOLVED |
| SCIO-469 and bortezomib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- description
- SCIO-469 two 30-mg capsules three times daily
- interventionNames
- Drug: SCIO-469
- type
- OTHER
- label
- 002
- description
- SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period
- interventionNames
- Drug: SCIO-469 and bortezomib
Primary outcomes (1)
- measure
- Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.