Clinical trial · Interventional
Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma
NCT00095680CI-TRIAL-00004050completedPhase 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 long-term effectiveness of SCIO-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.
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
- ACTIVE_COMPARATOR
- label
- 002
- description
- SCIO-469 and bortezomib The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
- interventionNames
- Drug: SCIO-469 and bortezomib
Primary outcomes (1)
- measure
- Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who did not have disease progression on Day 73 of Study B003 * patients fully understand all elements of, and have signed and dated, the written Informed Consent Form (ICF) before initiation of protocol-specified procedures Exclusion Criteria: * Patients who have an active uncontrolled infection * any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk to participate in the study * pregnant or lactating women, or who are not using adequate contraception * sexually active women of childbearing potential (WCBP) who do not agree to use at least two forms of medically accepted birth control, including one barrier method, for the duration of the study * men who do not agree to use an acceptable method for contraception throughout the study
References
Publications (0)
Data not yet available
No reference posted for this study.