Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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The main objective of this study is to assess the long-term efficacy 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. Patients took by mouth two capsules (60 mg) three times a day alone or in combination with bortezomib, for 168 days.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: SCIO-469
* Drug: SCIO-469 and bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>SCIO-469 two 30-mg capsules three times daily | Drug: SCIO-469<br>* two 30-mg capsules three times daily<br>|
| Active Comparator: 002<br>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 | Drug: SCIO-469 and bortezomib<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria. |  | Baseline to Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first response and time to best response |  | Baseline, Wks 6,12,18,24, Day 198 | 
| Size and number of lytic bone lesions were summarized. |  | Baseline, Wks 6,12,18,24, Day 198 | 
| Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale. |  | Baseline, Wks 6,12,18,24, Day 198 | 
| Performance status was evaluated by Karnofsky scale. |  | Baseline, Wks 6,12,18,24, Day 198 | 
| Bone disease was monitored by assessing various biomarkers. |  | Baseline, Wks 6,12,18,24, Day 198 | 
| Number of patients with disease progression |  | Wks 6,12,18,24, Day 198 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, SCIO-469, Bortezomib, p38 MAP kinase