Clinical Trials

A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

Location:

Trial status:

Closed

Why is this study being done?

The study was originally planned to have two phases. Phase II, the dose expansion phase, was not conducted.

Who is eligible to participate?

Inclusion Criteria:

1. Relapsed or refractory multiple myeloma patients requiring treatment with a non-bortezomib-containing regimen (prior treatment with bortezomib is acceptable)

• The diagnosis of symptomatic multiple myeloma (International Myeloma Working Group)

2. Patients with multiple myeloma who do not have measurable serum M-protein or measurable urine M-protein must have measurable increased concentrations of free light chains (using FreeLite™)

3. At least one prior SRE defined as one of the following:

- Pathologic fracture

- Spinal cord compression

- Requirement for either radiation or surgery to bone due to:

- Pain

- Prevention of imminent fracture

- Stabilization of a fracture

4. Current or planned treatment with zoledronic acid

5. Ambulatory patients aged 18 years or older

6. Adequate organ function

Exclusion Criteria:

1. Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone.

2. Current active dental problems including

- Ongoing infection of the teeth or jawbone (maxilla or mandibula)

- Current exposed bone in the mouth

- Dental or fixture trauma

- Current or previous osteonecrosis of the jaw

- Slow healing after dental procedures

- Recent (within 6 weeks) or planned dental or jaw surgery during the study (extraction, implants)

3. Patients who are allergic to/ intolerant of bisphosphonate therapy

4. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled diarrhea) that could cause unacceptable safety risks or compromise compliance with the protocol

5. Other clinically significant heart disease (e.g. symptomatic congestive heart failure, uncontrolled arrhythmia, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)

Other protocol-defined inclusion/exclusion criteria may apply

Last updated: 02/15/2013

NCT ID:

NCT00741377