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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087867
• Other study ID #: CR005152
• Secondary ID: SCIO-469MMY2001
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2004
• Last updated: October 15, 2010
• Start date: June 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2010
• Source: Scios, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• SCIO-469
two 30-mg capsules three times daily
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to first response, time to best response, and percentage of patients with disease progression were assessed.		Days 1, 15, 30, 52, and 73	No
Secondary	Size and number of lytic bone lesions were summarized.		screening and Day 73	No
Secondary	Quality of life and pain was assessed.		Days 1, 15,30,52,73	No
Secondary	Performance status was evaluated.		Screening, Days 1, 30, 73	No
Secondary	Bone disease was monitored by assessing various markers.		Days 1, 15, 30, 52, 73	No