Multiple MyelomaPhase 2NCT00087867
Study 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 efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. 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, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Sep 2005
- 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
- Life expectancy more than three months
- diagnosed with multiple myeloma (MM)
- relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
- Karnofsky performance status = 60
- no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
- no history of myocardial infarction within last 6 months
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- serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
- total serum bilirubin = 2X ULN
- Calculated or measured creatinine clearance >30 mL/min
- platelet count = 30 x 10(9)/L
- hemoglobin concentration = 8 g/dL
- white blood cell count = 2.0 x 10(9)/L
Who cannot join
- Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
- major surgery within four weeks of enrollment
- severe elevated serum calcium
- heart failure
- receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
- receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
- known allergies to agents used in bortezomib (e.g., boron or mannitol)
- poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
About this study
Official title: An Open-label 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 efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.
Read the detailed description
The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.
- Conditions
- Multiple Myeloma
- Being tested
- SCIO-469, SCIO-469 and bortezomib
- Keywords
- Multiple Myeloma, SCIO-469, p38 MAP kinase, myeloma, bone marrow
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
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
In addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | SCIO-469 two 30-mg capsules three times daily Receives: Drug: SCIO-469 |
| 002 | Other | SCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period Receives: Drug: SCIO-469 and bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
Measured: Day 73
Secondary outcomes (5)
Time to first response, time to best response, and percentage of patients with disease progression were assessed.
Measured: Days 1, 15, 30, 52, and 73
Size and number of lytic bone lesions were summarized.
Measured: screening and Day 73
Quality of life and pain was assessed.
Measured: Days 1, 15,30,52,73
Performance status was evaluated.
Measured: Screening, Days 1, 30, 73
Bone disease was monitored by assessing various markers.
Measured: Days 1, 15, 30, 52, 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2004 (estimated)
- Study startJun 2004
- Study completionSep 2005
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
- 62 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
- NCT00087867
- Sponsor's protocol ID
- CR005152
- Other IDs
- SCIO-469MMY2001 (B003)
- Status last verified
- Oct 2010
- First submitted
- 14 Jul 2004
- Last updated
- 18 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed, Refractory Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00087867
- Acronym / sponsor ID
- CR005152
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, SCIO-469, p38 MAP kinase, myeloma, bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Scios, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 19 Jul 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 efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.
Detailed description
The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.
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 | Other | Drug: SCIO-469 and bortezomibSCIO-469 and bortezomib In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Life expectancy more than three months
- diagnosed with multiple myeloma (MM)
- relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
- Karnofsky performance status = 60
- no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
Key exclusion criteria (8 listed)
- Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
- major surgery within four weeks of enrollment
- severe elevated serum calcium
- heart failure
- receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
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 bortezomibIn addition to SCIO-469, patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1, 4, 8, and 11 of a 21-day cycle, followed by a 10-day rest period | Drug | 002 |
Primary outcome
Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
Time frame: Day 73
5 secondary outcomes
Time to first response, time to best response, and percentage of patients with disease progression were assessed.
Time frame: Days 1, 15, 30, 52, and 73
Size and number of lytic bone lesions were summarized.
Time frame: screening and Day 73
Quality of life and pain was assessed.
Time frame: Days 1, 15,30,52,73
Performance status was evaluated.
Time frame: Screening, Days 1, 30, 73
Bone disease was monitored by assessing various markers.
Time frame: Days 1, 15, 30, 52, 73
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 18 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 12 inclusion and 8 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 18 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?
Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions. (time frame: Day 73). 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 18 Oct 2010.