Clinical trial NCT00095680: Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
SCIO-469
Bortezomib
p38 MAP kinase
Lead sponsor: Scios, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
timeFrame: Baseline to Day 168
Secondary outcomes:
measure: Time to first response and time to best response
timeFrame: Baseline, Wks 6,12,18,24, Day 198
measure: Size and number of lytic bone lesions were summarized.
timeFrame: Baseline, Wks 6,12,18,24, Day 198
measure: Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.
timeFrame: Baseline, Wks 6,12,18,24, Day 198
measure: Performance status was evaluated by Karnofsky scale.
timeFrame: Baseline, Wks 6,12,18,24, Day 198
measure: Bone disease was monitored by assessing various biomarkers.
timeFrame: Baseline, Wks 6,12,18,24, Day 198
measure: Number of patients with disease progression
timeFrame: Wks 6,12,18,24, Day 198
Other outcomes:
Locations:
Study officials:
affiliation: Scios, Inc.
name: Scios, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: