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

Scios, Inc.

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: SCIO-469 and bortezomib; Drug: SCIO-469

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095680

CR005182

SCIO-469MMY2002 (B006)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

001

Experimental group

Description:

SCIO-469 two 30-mg capsules three times daily

Treatment:

Drug: SCIO-469

002

Active Comparator group

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

Treatment:

Drug: SCIO-469 and bortezomib