Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease, Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Nephrology / Urology, Oncology
Healthy:	No
Age Range:	55 - Any
Updated:	3/30/2013
Start Date:	January 2012
End Date:	February 2015
Contact:	Novartis Pharmaceuticals
Phone:	+1(800)340-6843

A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency

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.

Inclusion Criteria:

1. Confirmed diagnosis of multiple myeloma

2. Life expectancy of more than 6 months in the absence of intervention

3. Must not have received previous or be receiving current antimyeloma therapies

4. Renal insufficiency

5. Recovered from the effects of any prior surgery or radiotherapy

Exclusion Criteria:

1. Prior IV bisphosphonate therapy at any time or oral bisphosphonate therapy within 4
months of study entry

2. Paget's disease of bone or uncorrected hyperparathyroidism

3. Impaired cardiac function

4. Known HIV, known active hepatitis B, or known or suspected hepatitis C infection

5. Pregnant or nursing (lactating) women,

6. Women of child-bearing potential, UNLESS agreeable to using 2 birth control methods

Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital

Columbus, Ohio 43210

from

Columbus, OH