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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCIO-469

SCIO-469 and bortezomib

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, SCIO-469, Bortezomib, p38 MAP kinase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

001

002

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first response and time to best response

Size and number of lytic bone lesions were summarized.

Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.

Performance status was evaluated by Karnofsky scale.

Bone disease was monitored by assessing various biomarkers.

Number of patients with disease progression

Full Information

NCT ID

NCT00095680

First Posted

November 5, 2004

Last Updated

October 21, 2010

Sponsor

Scios, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00095680

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Scios, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, SCIO-469, Bortezomib, p38 MAP kinase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

001

Arm Type

Experimental

Arm Description

SCIO-469 two 30-mg capsules three times daily

Arm Title

002

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

SCIO-469

Intervention Description

two 30-mg capsules three times daily

Intervention Type

Drug

Intervention Name(s)

SCIO-469 and bortezomib

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline to Day 168

Secondary Outcome Measure Information:

Title

Time to first response and time to best response

Time Frame