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

NCT ID: NCT00095680

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-02-28

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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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001

SCIO-469 two 30-mg capsules three times daily

Group Type EXPERIMENTAL

SCIO-469

Intervention Type DRUG

two 30-mg capsules three times daily

002

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

Group Type ACTIVE_COMPARATOR

SCIO-469 and bortezomib

Intervention Type DRUG

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

Interventions

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SCIO-469

two 30-mg capsules three times daily

Intervention Type DRUG

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scios, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Principal Investigators

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Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

Other Identifiers

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SCIO-469MMY2002 (B006)

Identifier Type: -

Identifier Source: secondary_id

CR005182

Identifier Type: -

Identifier Source: org_study_id