A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
18 Years
N/A
Both
Multiple Myeloma
Trial Information
A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
ยท 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.
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Attaya Suvannasankha, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, LLC
Authority:
United States: Institutional Review Board
Study ID:
HOG MM02-35
NCT ID:
NCT00216151
Start Date:
June 2005
Completion Date:
March 2007
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Bisphosphonates
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Arnett Cancer Care | Lafayette, Indiana 47904 |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
| Providence Medical Group | Terre Haute, Indiana 47802 |
| Elkhart Clinic | Elkhart, Indiana 46515 |
| Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
| AP&S Clinic | Terre Haute, Indiana 47804 |
