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

September 12, 2005
April 28, 2011
June 2005
March 2007   (final data collection date for primary outcome 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
· 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.
Complete list of historical versions of study NCT00216151 on ClinicalTrials.gov Archive Site
· 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 ]
· 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.
Not Provided
Not Provided
 
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Multiple Myeloma
Drug: Zoledronic Acid
Zoledronic Acid 4mg, every three months
  • Active Comparator: A
    Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
    Intervention: Drug: Zoledronic Acid
  • No Intervention: B
    Patients will be randomly assigned by study number to observation only.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00216151
HOG MM02-35
Yes
Attaya Suvannasankha, M.D., Hoosier Oncology Group
Hoosier Cancer Research Network
  • Novartis Pharmaceuticals
  • Walther Cancer Institute
Study Chair: Attaya Suvannasankha, M.D. Hoosier Oncology Group, LLC
Hoosier Cancer Research Network
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP