Scio-469 belongs to a new class of treatment that inhibits p38 MAP kinase. p38 MAPK activation controls the production of a number of factors that play a pathogenic role in the development of multiple myeloma (MM), most prominently IL-6, as well as IL-1, TNF, PGE2, IL-11, VEGF, macrophage inflammatory protein-1 (MIP-1), and RANKL. These factors are produced by MM cells and bone marrow stromal cells (BMSCs) when stimulated by secreted factors or by adherence of MM cells to BMSCs. A cytokine network, in which these factors induce each other in feed forward loops, sets up a perpetuating activated state that supports MM cell growth, survival, resistance to cytotoxic chemotherapy, and the development of osteolytic lesions. Disrupting this network at multiple points through the inhibition of p38 MAPK is thus expected to reduce MM growth and survival, increase sensitivity to cytotoxic agents, and reduce pain and fractures from osteolytic lesions. The main objective of this study is to assess the long-term efficacy of SCIO-469 as monotherapy, or in combination with Bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.

Condition	Treatment or Intervention	Phase
Multiple Myeloma	Drug: SCIO-469	Phase II

Further Study Details: 

Expected Total Enrollment:  60

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects who demonstrated clinical benefit (no disease progression on Day 73) with SCIO-469, alone or in combination with bortezomib, on Day 73 of Study B003.
• Fully understand all elements of, and have signed and dated, the written Informed Consent Form (ICF) before initiation of protocol-specified procedures.

Exclusion Criteria:

• Active uncontrolled infection
• Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if s/he were to participate in the study.
• Pregnant or lactating women, or who are not using adequate contraception
• Sexually active women of childbearing potential (WCBP) who do not agree to use at least two forms of medically accepted birth control, including one barrier method, for the duration of the study.
• Men who do not agree to use an acceptable method for contraception throughout the study.

Stephanie D Hanson      (510) 248-2652    hanson@sciosinc.com

Arkansas
      University of Arkansas, Myeloma Institute, Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
California
      City Of Hope Medical Center, Duarte,  California,  91010,  United States; Recruiting
Florida
      H. Lee Moffitt Cancer Center, Tampa,  Florida,  33612,  United States; Recruiting
      University of Florida at Gainesville, Gainesville,  Florida,  32610,  United States; Recruiting
Georgia
      Emory University Hospital, Atlanta,  Georgia,  30322,  United States; Recruiting
Iowa
      University of Iowa, Iowa City,  Iowa,  52242,  United States; Not yet recruiting
Minnesota
      Mayo Clinic, Rochester, Rochester,  Minnesota,  55905,  United States; Recruiting
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      St. Vincent's Comprehensive Cancer Center, New York,  New York,  10011,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  97201,  United States; Not yet recruiting
Oregon
      Oregon Health & Science University, Portland,  Oregon,  97201,  United States; Not yet recruiting
Pennsylvania
      UPMC Cancer Pavillion, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
Texas
      Texas Medical Center / The Methodist Hospital, Houston,  Texas,  77030,  United States; Not yet recruiting
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States; Recruiting

Study ID Numbers:  B006
Record last reviewed:  March 2004
Last Updated:  March 15, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095680
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08