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| ID | Type | Description | Link |
|---|---|---|---|
| SCIO-469MMY2002 (B006) |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | SCIO-469 two 30-mg capsules three times daily |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCIO-469 | Drug | two 30-mg capsules three times daily |
| |
| SCIO-469 and bortezomib |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria. | Baseline to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first response and time to best response | Baseline, Wks 6,12,18,24, Day 198 | |
| Size and number of lytic bone lesions were summarized. | Baseline, Wks 6,12,18,24, Day 198 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scios, Inc. Clinical Trial | Scios, Inc. | Study Director |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C499748 | SCIO-469 |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Drug |
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 |
|
| Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale. |
| Baseline, Wks 6,12,18,24, Day 198 |
| Performance status was evaluated by Karnofsky scale. | Baseline, Wks 6,12,18,24, Day 198 |
| Bone disease was monitored by assessing various biomarkers. | Baseline, Wks 6,12,18,24, Day 198 |
| Number of patients with disease progression | Wks 6,12,18,24, Day 198 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |