Multiple MyelomaPhase 2NCT00216151
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
A Phase 2 study testing Zoledronic Acid in people with Multiple Myeloma, run by Hoosier Cancer Research Network at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Zoledronic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2005to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Elkhart Clinic
Elkhart, Indiana, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Arnett Cancer Care
Lafayette, Indiana, 47904
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Providence Medical Group
Terre Haute, Indiana, 47802
AP&S Clinic
Terre Haute, Indiana, 47804
About this study
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
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
Read the 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
- Conditions
- Multiple Myeloma
- Being tested
- Zoledronic Acid
- Keywords
- Multiple Myeloma, Bisphosphonates
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Zoledronic Acid 4mg, every three months
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months. Receives: Drug: Zoledronic Acid |
| B | No intervention | Patients will be randomly assigned by study number to observation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
· 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.
Measured: 18 months
Secondary outcomes (1)
· 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Study terminated due to low patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Walther Cancer Institute
- Investigators
- Attaya Suvannasankha, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216151
- Sponsor's protocol ID
- HOG MM02-35
- Status last verified
- Apr 2011
- First submitted
- 12 Sep 2005
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00216151
- Acronym / sponsor ID
- HOG MM02-35
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bisphosphonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low patient enrollment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Walther Cancer Institute
- Study start
- Jun 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Zoledronic AcidPatients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months. |
| B | No intervention | –Patients will be randomly assigned by study number to observation only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidZoledronic Acid 4mg, every three months | Drug | A |
Primary outcome
· 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
1 secondary outcome
· 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
Results and safety
The study was stopped early (reason given: Study terminated due to low patient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attaya Suvannasankha, M.D. study chair
Hoosier Oncology Group, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic Acid in people with Multiple Myeloma, run by Hoosier Cancer Research Network at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to low patient enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.