Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

October 15, 2010 updated by: Scios, Inc.

An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
SCIO-469 two 30-mg capsules three times daily
Drug: SCIO-469
two 30-mg capsules three times daily
Other: 002
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Day 73
Day 73

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first response, time to best response, and percentage of patients with disease progression were assessed.
Time Frame: Days 1, 15, 30, 52, and 73
Days 1, 15, 30, 52, and 73
Size and number of lytic bone lesions were summarized.
Time Frame: screening and Day 73
screening and Day 73
Quality of life and pain was assessed.
Time Frame: Days 1, 15,30,52,73
Days 1, 15,30,52,73
Performance status was evaluated.
Time Frame: Screening, Days 1, 30, 73
Screening, Days 1, 30, 73
Bone disease was monitored by assessing various markers.
Time Frame: Days 1, 15, 30, 52, 73
Days 1, 15, 30, 52, 73

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scios, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

July 14, 2004

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

October 18, 2010

Last Update Submitted That Met QC Criteria

October 15, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005152
  • SCIO-469MMY2001 (B003)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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