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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Hoosier Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma focused on measuring Multiple Myeloma, Bisphosphonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Elkhart Clinic
  • Oncology Hematology Associates of SW Indiana
  • Indiana University Cancer Center
  • Quality Cancer Center (MCGOP)
  • Arnett Cancer Care
  • Northern Indiana Cancer Research Consortium
  • Providence Medical Group
  • AP&S Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

A

B

Arm Description

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

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

Outcomes

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.

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.

Full Information

First Posted
September 12, 2005
Last Updated
April 28, 2011
Sponsor
Hoosier Cancer Research Network
Collaborators
Novartis Pharmaceuticals, Walther Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00216151
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to low patient enrollment.
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoosier Cancer Research Network
Collaborators
Novartis Pharmaceuticals, Walther Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Bisphosphonates

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
Arm Title
B
Arm Type
No Intervention
Arm Description
Patients will be randomly assigned by study number to observation only.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Intervention Description
Zoledronic Acid 4mg, every three months
Primary Outcome Measure Information:
Title
· 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 Outcome Measure Information:
Title
· 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Attaya Suvannasankha, M.D.
Organizational Affiliation
Hoosier Oncology Group, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Elkhart Clinic
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Quality Cancer Center (MCGOP)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Arnett Cancer Care
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Providence Medical Group
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
AP&S Clinic
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hoosieroncologygroup.org/
Description
Hoosier Oncology Group Home Page

Learn more about this trial

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

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