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:
Hoosier Oncology Group
Collaborators:
Novartis Pharmaceuticals
Walther Cancer Institute
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT00216151
First received: September 12, 2005
Last updated: April 28, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Oncology Group:
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
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 Oncology Group
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 Oncology Group:
|
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 May 21, 2013