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Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00095680
Recruitment Status : Completed
First Posted : November 8, 2004
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Scios, Inc.

Brief Summary:
The main objective of this study is to assess the long-term effectiveness 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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: SCIO-469 Drug: SCIO-469 and bortezomib Phase 2

Detailed Description:
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. Patients took by mouth two capsules (60 mg) three times a day alone or in combination with bortezomib, for 168 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma
Study Start Date : November 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: 001
SCIO-469 two 30-mg capsules three times daily
Drug: SCIO-469
two 30-mg capsules three times daily

Active Comparator: 002
SCIO-469 and bortezomib The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
Drug: SCIO-469 and bortezomib
The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study




Primary Outcome Measures :
  1. Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria. [ Time Frame: Baseline to Day 168 ]

Secondary Outcome Measures :
  1. Time to first response and time to best response [ Time Frame: Baseline, Wks 6,12,18,24, Day 198 ]
  2. Size and number of lytic bone lesions were summarized. [ Time Frame: Baseline, Wks 6,12,18,24, Day 198 ]
  3. Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale. [ Time Frame: Baseline, Wks 6,12,18,24, Day 198 ]
  4. Performance status was evaluated by Karnofsky scale. [ Time Frame: Baseline, Wks 6,12,18,24, Day 198 ]
  5. Bone disease was monitored by assessing various biomarkers. [ Time Frame: Baseline, Wks 6,12,18,24, Day 198 ]
  6. Number of patients with disease progression [ Time Frame: Wks 6,12,18,24, Day 198 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who did not have disease progression on Day 73 of Study B003
  • patients fully understand all elements of, and have signed and dated, the written Informed Consent Form (ICF) before initiation of protocol-specified procedures

Exclusion Criteria:

  • Patients who have an active uncontrolled infection
  • any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095680


Sponsors and Collaborators
Scios, Inc.
Investigators
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Study Director: Scios, Inc. Clinical Trial Scios, Inc.
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Responsible Party: VP Clinical Oncology, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00095680    
Other Study ID Numbers: CR005182
SCIO-469MMY2002 (B006)
First Posted: November 8, 2004    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: October 2010
Keywords provided by Scios, Inc.:
Multiple Myeloma
SCIO-469
Bortezomib
p38 MAP kinase
Additional relevant MeSH terms:
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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