- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00095680
Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
October 21, 2010 updated by: Scios, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
SCIO-469 two 30-mg capsules three times daily
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Time Frame: Baseline to Day 168
|
Baseline to Day 168
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first response and time to best response
Time Frame: Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
Size and number of lytic bone lesions were summarized.
Time Frame: Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.
Time Frame: Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
Performance status was evaluated by Karnofsky scale.
Time Frame: Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
Bone disease was monitored by assessing various biomarkers.
Time Frame: Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
Number of patients with disease progression
Time Frame: Wks 6,12,18,24, Day 198
|
Wks 6,12,18,24, Day 198
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
November 5, 2004
First Submitted That Met QC Criteria
November 5, 2004
First Posted (Estimate)
November 8, 2004
Study Record Updates
Last Update Posted (Estimate)
October 22, 2010
Last Update Submitted That Met QC Criteria
October 21, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- CR005182
- SCIO-469MMY2002 (B006)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on SCIO-469
-
Scios, Inc.CompletedMyelodysplastic Syndromes | Bone Marrow Diseases | Hematologic Diseases | Bone Marrow Neoplasms
-
Scios, Inc.Completed
-
Scios, Inc.Completed
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Scios, Inc.CompletedArthritis, Rheumatoid
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Maitreya Kft.CompletedStressUnited States, France, Germany, Romania
-
LEO PharmaCompleted
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Kasey PhiferTerminatedLyme Disease | Lyme Arthritis | Lyme Neuroborreliosis | Unknown Origin FeverUnited Kingdom