Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency
Completed · Phase 2 · Has a placebo group
Conditions studied: Multiple Myeloma, Renal Insufficiency
In brief
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.
Key facts
- Study ID
- NCT01337752
- Run by
- Novartis Pharmaceuticals
- People needed
- 9
- Starts
- 2012-01-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2020-12-17
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of multiple myeloma
- Life expectancy of more than 6 months in the absence of intervention
- Must not have received previous or be receiving current antimyeloma therapies
- Renal insufficiency
- Recovered from the effects of any prior surgery or radiotherapy
You may not qualify if…
- Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4 months of study entry
- Paget's disease of bone or uncorrected hyperparathyroidism
- Impaired cardiac function
- Known HIV, known active hepatitis B, or known or suspected hepatitis C infection
- Pregnant or nursing (lactating) women,
- Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- University Chicago Hospital Dept. of Univ of Chicago (2) — Chicago, Illinois, United States
- Medical Oncology Associates, PS — Spokane, Washington, United States
- Novartis Investigative Site — Valencia, Valencia, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Bournemouth, United Kingdom
- Novartis Investigative Site — Manchester, United Kingdom
- Novartis Investigative Site — Oxford, United Kingdom
- Novartis Investigative Site — Southampton, United Kingdom
Full record on ClinicalTrials.gov
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