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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095680
• Other study ID #: CR005182
• Secondary ID: SCIO-469MMY2002
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2004
• Last updated: October 21, 2010
• Start date: November 2004
• Est. completion date: February 2006

Study information

• Verified date: October 2010
• Source: Scios, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SCIO-469
two 30-mg capsules three times daily
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.		Baseline to Day 168	No
Secondary	Time to first response and time to best response		Baseline, Wks 6,12,18,24, Day 198	No
Secondary	Size and number of lytic bone lesions were summarized.		Baseline, Wks 6,12,18,24, Day 198	No
Secondary	Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.		Baseline, Wks 6,12,18,24, Day 198	No
Secondary	Performance status was evaluated by Karnofsky scale.		Baseline, Wks 6,12,18,24, Day 198	No
Secondary	Bone disease was monitored by assessing various biomarkers.		Baseline, Wks 6,12,18,24, Day 198	No
Secondary	Number of patients with disease progression		Wks 6,12,18,24, Day 198	No