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A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event


Phase 1
18 Years
78 Years
Not Enrolling
Both
Multiple Myeloma Bone Disease

Thank you

Trial Information

A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to first SRE and change in bone markers for bone resorption and formation

Outcome Time Frame:

9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and std anti-myeloma therapy

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBHQ880A2102

NCT ID:

NCT00741377

Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

  • Multiple Myeloma Bone Disease
  • Multiple myeloma
  • bone disease
  • antibody
  • Bone Diseases
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (11)Houston, Texas  77030-4009
Mayo Clinic - Arizona Cancer Clinical Research UnitScottsdale, Arizona  85259
Dana Farber Cancer Institute Deptof DanaFarberCancerInst(2)Boston, Massachusetts  02115
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(4)San Antonio, Texas  78229