Clinical trial NCT00216151: Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
Official title: A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Bisphosphonates
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Walther Cancer Institute
First posted: 2005-09-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: · 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.
timeFrame: 18 months
Secondary outcomes:
measure: · 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.
timeFrame: 18 months
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Elkhart Clinic
state: Indiana
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Quality Cancer Center (MCGOP)
state: Indiana
city: Lafayette
country: United States
facility: Arnett Cancer Care
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: Terre Haute
country: United States
facility: AP&S Clinic
state: Indiana
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Attaya Suvannasankha, M.D.
role: STUDY_CHAIR
References: