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

This study has been terminated.
(Study terminated due to low patient enrollment.)
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00216151
First received: September 12, 2005
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Zoledronic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • · 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • · 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 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
Drug: Zoledronic Acid
Zoledronic Acid 4mg, every three months
No Intervention: B
Patients will be randomly assigned by study number to observation only.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216151

Locations
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
AP&S Clinic
Terre Haute, Indiana, United States, 47804
Providence Medical Group
Terre Haute, Indiana, United States, 47802
Sponsors and Collaborators
Hoosier Cancer Research Network
Novartis Pharmaceuticals
Walther Cancer Institute
Investigators
Study Chair: Attaya Suvannasankha, M.D. Hoosier Oncology Group, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Attaya Suvannasankha, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00216151     History of Changes
Other Study ID Numbers: HOG MM02-35
Study First Received: September 12, 2005
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hoosier Cancer Research Network:
Multiple Myeloma
Bisphosphonates

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014