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Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma

Phase 4
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma

Inclusion Criteria:

- Confirmed diagnosis of multiple myeloma

- Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been
initiated for osteolytic lesion, bone fracture, spinal compression or osteopenia due
to multiple myeloma

- Stable renal function

Exclusion Criteria:

- Known sensitivity to bisphosphonates

- Receiving investigational drugs considered not safe for co-administration or have
significant effect on bone turnover

- Current active dental problems

- Had bone marrow transplant or blood stem cell transplant within 2 months before study
entry or planned transplant within 2 months following enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Proportion of patients with ≥1 SRE at the end of one year on study.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

April 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • zoledronic acid
  • skeletal complications
  • bone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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Center for Cancer & Blood Disorders Bethesda, Maryland  20817
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Blood and Cancer Center of East Texas Tyler, Texas  75701
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