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

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: SCIO-469 Drug: SCIO-469 and bortezomib	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Further study details as provided by Scios, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Size and number of lytic bone lesions were summarized. [ Time Frame: screening and Day 73 ] [ Designated as safety issue: No ]
Quality of life and pain was assessed. [ Time Frame: Days 1, 15,30,52,73 ] [ Designated as safety issue: No ]
Performance status was evaluated. [ Time Frame: Screening, Days 1, 30, 73 ] [ Designated as safety issue: No ]
Bone disease was monitored by assessing various markers. [ Time Frame: Days 1, 15, 30, 52, 73 ] [ Designated as safety issue: No ]

Enrollment:	62
Study Start Date:	June 2004
Study Completion Date:	September 2005

Arms	Assigned Interventions
Experimental: 001 SCIO-469 two 30-mg capsules three times daily	Drug: SCIO-469 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	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087867

Sponsors and Collaborators

Scios, Inc.

Investigators

Study Director:

Scios, Inc. Clinical Trial

Scios, Inc.

More Information

No publications provided

Responsible Party:	VP Clinical Oncology, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00087867 History of Changes
Other Study ID Numbers:	CR005152, SCIO-469MMY2001 (B003)
Study First Received:	July 14, 2004
Last Updated:	October 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Scios, Inc.:

Multiple Myeloma
SCIO-469
p38 MAP kinase
myeloma
bone marrow

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013