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

NCT ID: NCT00087867

Last Updated: 2010-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-09-30

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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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

Group Type: OTHER

SCIO-469 and bortezomib

Intervention Type: DRUG

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

Interventions

SCIO-469

two 30-mg capsules three times daily

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

Other Identifiers

SCIO-469MMY2001 (B003)

Identifier Type: -

Identifier Source: secondary_id

CR005152

Identifier Type: -

Identifier Source: org_study_id