Status:
COMPLETED
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma Bone Disease
Eligibility:
All Genders
18-78 years
Phase:
PHASE1
Brief Summary
This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT)...
Detailed Description
The study was originally planned to have two phases. Phase II, the dose expansion phase, was not conducted.
Eligibility Criteria
Inclusion
- 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)
- 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™)
- 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
- Current or planned treatment with zoledronic acid
- Ambulatory patients aged 18 years or older
- Adequate organ function
Exclusion
- Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone.
- 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)
- Patients who are allergic to/ intolerant of bisphosphonate therapy
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00741377
Start Date
January 1 2009
End Date
December 1 2011
Last Update
February 18 2013
Active Locations (9)
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1
Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, United States, 85259
2
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
3
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(2)
Boston, Massachusetts, United States, 02115
4
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (11)
Houston, Texas, United States, 77030-4009