Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
NCT01337752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2020-12-17
Summary
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.
Conditions
- Multiple Myeloma
- Renal Insufficiency
Interventions
- DRUG
-
BHQ880
- DRUG
-
BHQ880 Placebo
Intravenous infusion
- DRUG
-
intravenous injection
- DRUG
-
Oral
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- United States
- Spain
- United Kingdom
Study Locations
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