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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: SCIO-469 and bortezomib; Drug: SCIO-469

• Registration Number: NCT00095680
• Lead Sponsor: Scios, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-11-05
• Study First Submitted QC: 2004-11-05
• Study First Posted: 2004-11-08
• Study Completion: 2006-02
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
002	SCIO-469 and bortezomib	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
001	SCIO-469	SCIO-469 two 30-mg capsules three times daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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