Multiple MyelomaPhase 2NCT00577642
Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
A Phase 2 study testing Zoledronic acid in people with Multiple Myeloma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men or women 18 years of age or older
- Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
- MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
- ECOG Performance Status of 0-2
Who cannot join
- MM patients on active anti-MM therapy (maintenance regimens allowed)
- Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
- Relapsed, refractory or progressive disease
- Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
- Hypersensitivity or any contraindication to a single dose of zoledronic acid
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates
The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.
Read the detailed description
- Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures.
- Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests.
- After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.
- Conditions
- Multiple Myeloma
- Being tested
- Zoledronic acid
- Keywords
- aminobisphosphonates
- 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
Also called Zometa
4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm biomarker study after a single dose of zoledronic acid Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr
Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, American Society of Clinical Oncology
- Responsible party
- Principal investigator, Noopur Raje, Massachusetts General Hospital
- Investigators
- Noopur Raje, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577642
- Sponsor's protocol ID
- 07-144
- Other IDs
- ASCO CDA
- Status last verified
- Jan 2017
- First submitted
- 18 Dec 2007
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Patel CG, Yee AJ, Scullen TA, Nemani N, Santo L, Richardson PG, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Raje NS. Biomarkers of bone remodeling in multiple myeloma patients to tailor bisphosphonate therapy. Clin Cancer Res. 2014 Aug 1;20(15):3955-61. doi: 10.1158/1078-0432.CCR-14-0434. Epub 2014 Jun 23.
PubMed 24958808
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bone Marker Assessment of Multiple Myeloma Patients Treated With AminoBisphosphonates
- ClinicalTrials.gov ID
- NCT00577642
- Acronym / sponsor ID
- 07-144
- Conditions
- Multiple Myeloma
- Keywords
- aminobisphosphonates
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Dana-Farber Cancer Institute, American Society of Clinical Oncology
- Study start
- Oct 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 10 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.
Detailed description
- Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures.
- Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests.
- After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Zoledronic acidSingle arm biomarker study after a single dose of zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women 18 years of age or older
- Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
- MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
- ECOG Performance Status of 0-2
Key exclusion criteria (5 listed)
- MM patients on active anti-MM therapy (maintenance regimens allowed)
- Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
- Relapsed, refractory or progressive disease
- Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
- Hypersensitivity or any contraindication to a single dose of zoledronic acid
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 acidAlso: Zometa4mg IV over at least 15 minutes or corrected for creatinine clearance x 1 | Drug | Single arm |
Primary outcome
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr
Time frame: 6 months
Number of participants with urinary NTX levels less than or equal to 50 nmol/mmol creatinine (Cr) for the duration of study followup, following a single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1). Dose administration was followed by Aminobisphosphonates (aBP) treatment cessation during study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24958808Patel CG, Yee AJ, Scullen TA, Nemani N, Santo L, Richardson PG, Laubach JP, Ghobrial IM, Schlossman RL, Munshi NC, Anderson KC, Raje NS. Biomarkers of bone remodeling in multiple myeloma patients to tailor bisphosphonate therapy. Clin Cancer Res. 2014 Aug 1;20(15):3955-61. doi: 10.1158/1078-0432.CCR-14-0434. Epub 2014 Jun 23.
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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.
Noopur Raje, MD principal investigator
Massachusetts General Hospital
1 site 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 Massachusetts General Hospital at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 10 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Urinary NTX Levels Less Than or Equal to 50nmol/mmol Cr (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00577642, which also lists 1 linked publication.
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 10 Mar 2017.