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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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 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.

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Day 73

Safety Issue:


Principal Investigator

Scios, Inc. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Scios, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

September 2005

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • SCIO-469
  • p38 MAP kinase
  • myeloma
  • bone marrow
  • Multiple Myeloma
  • Neoplasms, Plasma Cell