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A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

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 CenterIndianapolis, Indiana  46202-5265
Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Providence Medical GroupTerre Haute, Indiana  47802
Elkhart ClinicElkhart, Indiana  46515
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
AP&S ClinicTerre Haute, Indiana  47804