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The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib consolidation | Experimental | Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | 1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease response | Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT. | At 6 and 12 months after ASCT consolidated by bortezomib therapy |
| Number of patients with adverse events | The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT | Up to 8 months after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| assess effect of bortezomib consolidation on bone health | Summary of changes from baseline, after cycle 1,2 and 3 of bortezomib treatment and at the end of treatment for markers of bone formation and resorption | At 1, 2, 3 and 9 months after start of treatment |
| assess the effect of bortezomib consolidation on Minimal Residue Disease status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwee Yong | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London | London | United Kingdom |
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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 |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| At 6 and 12 months post ASCT |
| determine progression free survival | At 2 years post ASCT |
| evaluate the quality of life for patients receiving bortezomib consolidation | Up to 8 months after treatment start |
| 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 |