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

Phase 2TerminatedNCT00216151

Hoosier Cancer Research Network3 enrolled

Overview

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

OUTLINE: This is a multi-center study. * Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed. Performance status: ECOG performance status 0-3 (KPS 30 - 100) Life expectancy: 12 months Hematopoietic: * Hb \>10 g/dl within 14 days prior to registration Hepatic: * Not specified Renal: * Serum creatinine \< 2 mg/dl within 14 days prior to registration Cardiovascular: * Not specified Pulmonary: * Not specified

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Elkhart Clinic

Elkhart, Indiana, United States

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, United States

Arnett Cancer Care

Lafayette, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Providence Medical Group

Terre Haute, Indiana, United States

AP&S Clinic

Terre Haute, Indiana, United States

Outcomes

Primary Outcomes

· To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.

Time frame: 18 months

Secondary Outcomes

· To examine the effect of intravenous zoledronic acid at the above schedule on percent change in bone mineral density of the total hip and femur.

Time frame: 18 months