Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates.

This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoosier Cancer Research Network
• Collaborators: Novartis Pharmaceuticals; Walther Cancer Institute
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:

• Presence of bone marrow clonal plasma cells (more than 10%)

• Presence of an M-protein in serum and/or urine (no concentration specified)

• Serum calcium < 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey

• No symptoms of hyperviscosity, amyloidosis or recurrent infection

• Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration

• Negative pregnancy test

Exclusion Criteria:

• No previous treatment with bisphosphonates

• No disorders of the parathyroid or thyroid glands

• No current breastfeeding

• No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason < grade 7 prostate cancers