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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022029-13 | EudraCT Number |
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This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHQ880 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHQ880 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A | at 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values | From start of study until disease progression | |
| Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma |
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Inclusion Criteria:
Confirmed diagnosis of SMM with high-risk for progression to multiple myeloma
No previous or current anti-myeloma therapies
Patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 1
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | United States | ||
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| Label | URL |
|---|---|
| Results for CBHQ880A2204 from the Novartis Clinical Trials website | View source |
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| Throughout the study until disease progression |
| Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers | Throughout the study until disease progression |
| Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT | 6 months and 12 months |
| H. Lee Moffitt Cancer Center & Research Institute SC - 3 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) | Atlanta | Georgia | 30322 | United States |
| Indiana University Indiana Univ | Indianapolis | Indiana | 46202 | United States |
| Dana Farber Cancer Institute DFCI (2) | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine Dept. of WUSTL | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center Multiple Myeloma Division | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai School of Medicine Mt Sinai | New York | New York | 10029 | United States |
| Duke University Medical Center Duke SC | Durham | North Carolina | 27710 | United States |
| Fred Hutchinson Cancer Research Center Fred Hutchinson | Seattle | Washington | 98109 | United States |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| ID | Term |
|---|---|
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C557618 | BHQ880 |
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