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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010875-26 | EudraCT Number |
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The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHQ880 + bortezomib and dexamethasone | Experimental |
| |
| BHQ880 Placebo + bortezomib and dexamethasone | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHQ880 | Drug |
| ||
| BHQ880 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone | Time to first SRE from randomization | 18-month median time to first SRE assumed for the placebo arm |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone | Number of patients with adverse events/serious adverse events, abnormal clinical laboratory values, and the assessment of immunogenicity | From screening through month 17 |
| Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| University Chicago Hospital Dept. of Univ of Chicago (2) | Chicago | Illinois | 60637 | United States | ||
| Medical Oncology Associates, PS |
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| Label | URL |
|---|---|
| Results for CBHQ880A2203 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C557618 | BHQ880 |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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Intravenous infusion |
|
| bortezomib | Drug | intravenous injection |
|
| dexamethasone | Drug | Oral |
|
Determine the pharmacokinetic parameters for BHQ880 and bortezomib (Cmax, Tmax, AUC0-tlast, t1/2, and accumulation ratio of BHQ880). |
| At screening and weeks 1, 2, 4, 7, 10, 11, 13, 16, 25 and 34 |
| Evaluate the effect of BHQ880 on bone metabolism | 1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), from randomization to 12 and 18 months; 2) Change in bone strength, measured by quantitative computed tomography (qCT), from randomization to 3 and 6 months | At screening and at months 3, 6, 12, and 18 |
| Determine the antimyeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone. | 1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880 | From the first dose of study medication through month 17 |
| Spokane |
| Washington |
| 99208 |
| United States |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Madrid | 28006 | Spain |
| Novartis Investigative Site | Bournemouth | BH7 7DW | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Oxford | OX3 7LJ | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| 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 |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |