NCT00087867

Brief Summary

The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

October 18, 2010

Status Verified

October 1, 2010

First QC Date

July 14, 2004

Last Update Submit

October 15, 2010

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaSCIO-469p38 MAP kinasemyelomabone marrow

Outcome Measures

Primary Outcomes (1)

  • Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.

    Day 73

Secondary Outcomes (5)

  • Time to first response, time to best response, and percentage of patients with disease progression were assessed.

    Days 1, 15, 30, 52, and 73

  • Size and number of lytic bone lesions were summarized.

    screening and Day 73

  • Quality of life and pain was assessed.

    Days 1, 15,30,52,73

  • Performance status was evaluated.

    Screening, Days 1, 30, 73

  • Bone disease was monitored by assessing various markers.

    Days 1, 15, 30, 52, 73

Study Arms (2)

001

EXPERIMENTAL

SCIO-469 two 30-mg capsules three times daily

Drug: SCIO-469

002

OTHER

SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period

Drug: SCIO-469 and bortezomib

Interventions

SCIO-469DRUG

two 30-mg capsules three times daily

001
SCIO-469 and bortezomibDRUG

In addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period

002

Eligibility Criteria

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

You may qualify if:

  • Life expectancy more than three months
  • diagnosed with multiple myeloma (MM)
  • relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
  • Karnofsky performance status = 60
  • no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
  • no history of myocardial infarction within last 6 months
  • serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
  • total serum bilirubin = 2X ULN
  • Calculated or measured creatinine clearance \>30 mL/min
  • platelet count = 30 x 10(9)/L
  • hemoglobin concentration = 8 g/dL
  • white blood cell count = 2.0 x 10(9)/L

You may not qualify if:

  • Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
  • major surgery within four weeks of enrollment
  • severe elevated serum calcium
  • heart failure
  • receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
  • receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
  • known allergies to agents used in bortezomib (e.g., boron or mannitol)
  • poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

SCIO-469Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms 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

July 14, 2004

First Posted

July 19, 2004

Study Start

June 1, 2004

Study Completion

September 1, 2005

Last Updated

October 18, 2010

Record last verified: 2010-10