NCT00216151

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

September 12, 2005

Last Update Submit

April 28, 2011

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaBisphosphonates

Outcome Measures

Primary Outcomes (1)

  • · 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.

    18 months

Secondary Outcomes (1)

  • · 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.

    18 months

Study Arms (2)

A

ACTIVE COMPARATOR

Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.

Drug: Zoledronic Acid

B

NO INTERVENTION

Patients will be randomly assigned by study number to observation only.

Interventions

Zoledronic AcidDRUG

Zoledronic Acid 4mg, every three months

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Quality Cancer Center (MCGOP)

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Attaya Suvannasankha, M.D.

    Hoosier Oncology Group, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

US(8)