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

Scios, Inc.30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

SCIO-469DRUG

two 30-mg capsules three times daily

SCIO-469 and bortezomibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.

Time frame: Baseline to Day 168