NCT00095680

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2 multiple-myeloma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 22, 2010

Status Verified

October 1, 2010

First QC Date

November 5, 2004

Last Update Submit

October 21, 2010

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaSCIO-469Bortezomibp38 MAP kinase

Outcome Measures

Primary Outcomes (1)

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

    Baseline to Day 168

Secondary Outcomes (6)

  • Time to first response and time to best response

    Baseline, Wks 6,12,18,24, Day 198

  • Size and number of lytic bone lesions were summarized.

    Baseline, Wks 6,12,18,24, Day 198

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

    Baseline, Wks 6,12,18,24, Day 198

  • Performance status was evaluated by Karnofsky scale.

    Baseline, Wks 6,12,18,24, Day 198

  • Bone disease was monitored by assessing various biomarkers.

    Baseline, Wks 6,12,18,24, Day 198

  • +1 more secondary outcomes

Study Arms (2)

001

EXPERIMENTAL

SCIO-469 two 30-mg capsules three times daily

Drug: SCIO-469

002

ACTIVE COMPARATOR

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

Drug: SCIO-469 and bortezomib

Interventions

SCIO-469DRUG

two 30-mg capsules three times daily

001
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

002

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

SCIO-469Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Scios, Inc. Clinical Trial

    Scios, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 5, 2004

First Posted

November 8, 2004

Study Start

November 1, 2004

Study Completion

February 1, 2006

Last Updated

October 22, 2010

Record last verified: 2010-10