Overview

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

Status:
Completed

Trial end date:
2013-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Bortezomib
Dexamethasone

Criteria

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