Multiple MyelomaPhase 2NCT00095680
Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
A Phase 2 study testing SCIO-469 and SCIO-469 and bortezomib in people with Multiple Myeloma, run by Scios, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SCIO-469 and SCIO-469 and bortezomib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- SCIO-469, SCIO-469 and bortezomib
- Keywords
- Multiple Myeloma, SCIO-469, Bortezomib, p38 MAP kinase
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIO-469Drug
two 30-mg capsules three times daily
SCIO-469 and bortezomibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | SCIO-469 two 30-mg capsules three times daily Receives: Drug: SCIO-469 |
| 002 | Active comparator | 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 Receives: Drug: SCIO-469 and bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Measured: Baseline to Day 168
Secondary outcomes (6)
Time to first response and time to best response
Measured: Baseline, Wks 6,12,18,24, Day 198
Size and number of lytic bone lesions were summarized.
Measured: Baseline, Wks 6,12,18,24, Day 198
Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.
Measured: Baseline, Wks 6,12,18,24, Day 198
Performance status was evaluated by Karnofsky scale.
Measured: Baseline, Wks 6,12,18,24, Day 198
Bone disease was monitored by assessing various biomarkers.
Measured: Baseline, Wks 6,12,18,24, Day 198
Number of patients with disease progression
Measured: Wks 6,12,18,24, Day 198
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startNov 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scios, Inc. Clinical Trial, Study director, Scios, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095680
- Sponsor's protocol ID
- CR005182
- Other IDs
- SCIO-469MMY2002 (B006)
- Status last verified
- Oct 2010
- First submitted
- 5 Nov 2004
- Last updated
- 22 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00095680
- Acronym / sponsor ID
- CR005182
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, SCIO-469, Bortezomib, p38 MAP kinase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: SCIO-469SCIO-469 two 30-mg capsules three times daily |
| 002 | Active comparator | Drug: SCIO-469 and bortezomibSCIO-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCIO-469two 30-mg capsules three times daily | Drug | 001 |
| SCIO-469 and bortezomibThe 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 | 002 |
Primary outcome
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Time frame: Baseline to Day 168
6 secondary outcomes
Time to first response and time to best response
Time frame: 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
Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.
Time frame: 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
Bone disease was monitored by assessing various biomarkers.
Time frame: Baseline, Wks 6,12,18,24, Day 198
Number of patients with disease progression
Time frame: Wks 6,12,18,24, Day 198
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scios, Inc. Clinical Trial study director
Scios, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCIO-469 and SCIO-469 and bortezomib in people with Multiple Myeloma, run by Scios, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria. (time frame: Baseline to Day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.