Multiple MyelomaNCT02212262
Role of Osteocytes in Myeloma Bone Disease
An observational study of Multiple Myeloma, run by Attaya Suvannasankha at 2 sites in United States.
Trial summary
Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2014to 5 Feb 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample
Who may be able to join
- Age > 18 years but ≤ 95 years at the time of consent
- Subjects must be English-speaking
- Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
- Have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
- Have no known liver or kidney disorders
Who cannot join
- Pregnant females will be excluded from the study.
- Subjects allergic to xylocaine will be excluded.
- Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
- History of bleeding disorders.
- Subjects deemed incompetent by treating physician
- Institutionalized, mentally disabled subjects
- Subjects who are prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
VA Roudebush Medical Center
Indianapolis, Indiana, 46202
About this study
Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Treatments need to block centrally important, multifunctional pathways. The investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase due to FGF23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of FGF23 excess, such as chronic kidney disease (Shimada \& Fukamoto, 2012), and could be used in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has adverse effects, but neutralization of FGF23 excess may be practical, or in the future, suppression of excess FGF23 biosynthesis by osteocytes.
The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Patients | Patients with multiple myeloma will undergo a blood draw and a bone marrow aspirate. Extra bone marrow will be taken for study purposes only. | |
| Healthy subjects | Healthy subjects and multiple myeloma patients will undergo a blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular interactions between multiple myeloma and osteocytes
To determine FGF23 and heparanase, Dkk1 and plasma klotho levels increase in patients with newly diagnosed and relapsed myeloma compared to healthy controls.
Measured: Up to 4 years
Secondary outcomes (2)
Multiple Myeloma osteocytes and tumor staging
To correlate the FGF23, heparanase, Dkk1 and plasma klotho to tumor staging
Measured: Up to 4 years
Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption
To correlate the FGF23, heparanase, Dkk1 and plasma klotho to extent of bone resorption using serum type I collagen fragments ICTP and CTX
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study start7 Oct 2014
- Primary completion5 Feb 2022
- Study completion5 Feb 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attaya Suvannasankha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Attaya Suvannasankha, Indiana University
- Investigators
- Attaya Suvannasankha, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212262
- Sponsor's protocol ID
- IUCRO-0498
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2014
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Osteocytes in Myeloma Bone Disease
- ClinicalTrials.gov ID
- NCT02212262
- Acronym / sponsor ID
- IUCRO-0498
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Attaya SuvannasankhaUniversity, hospital or other
- Study start
- 7 Oct 2014 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 5 Feb 2022 (actual)
- First posted
- 8 Aug 2014 (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.
Progress in the treatment of myeloma and myeloma bone disease has substantially increased overall survival, but relapse is inevitable and better treatment is needed. The bone microenvironment is tremendously complex, so that targeting single interactions between tumor and bone is unlikely to be effective. Treatments need to block centrally important, multifunctional pathways. The investigators data point to a central role of the osteocyte to induce heparanase, a multifunctional mediator of myeloma bone disease. Increased heparanase due to FGF23 may make systemic inhibitors of heparanase less effective in bone than elsewhere. FGF23 neutralizing antibodies have been developed for non-cancer conditions of FGF23 excess, such as chronic kidney disease (Shimada \& Fukamoto, 2012), and could be used in MM alone or in combination with heparanase inhibitors. Complete neutralization of FGF23 has adverse effects, but neutralization of FGF23 excess may be practical, or in the future, suppression of excess FGF23 biosynthesis by osteocytes.
The investigators hope to determine serum FGF23 and heparanase, Dkk1 and plasma klotho levels in patients with newly diagnosed and relapsed myeloma compared to healthy controls with this exploratory study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Patients | – | –Patients with multiple myeloma will undergo a blood draw and a bone marrow aspirate. Extra bone marrow will be taken for study purposes only. |
| Healthy subjects | – | –Healthy subjects and multiple myeloma patients will undergo a blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology Clinics at Indiana University Roudebuch VA Medical Center Community sample
Key inclusion criteria (5 listed)
- Age > 18 years but ≤ 95 years at the time of consent
- Subjects must be English-speaking
- Must voluntarily sign the most current informed consent and HIPAA documents prior to study participation.
- Have no prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers can also be enrolled as healthy volunteers.
- Have no known liver or kidney disorders
Key exclusion criteria (7 listed)
- Pregnant females will be excluded from the study.
- Subjects allergic to xylocaine will be excluded.
- Subjects with an acute illness (Ex. upper respiratory infection, viral illness) in the past seven days will be excluded.
- History of bleeding disorders.
- Subjects deemed incompetent by treating physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular interactions between multiple myeloma and osteocytes
Time frame: Up to 4 years
To determine FGF23 and heparanase, Dkk1 and plasma klotho levels increase in patients with newly diagnosed and relapsed myeloma compared to healthy controls.
2 secondary outcomes
Multiple Myeloma osteocytes and tumor staging
Time frame: Up to 4 years
Multiple Myeloma osteocytes and Type I collagen fragments on bone resorption
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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. principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Attaya Suvannasankha at 2 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 5 inclusion and 7 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Molecular interactions between multiple myeloma and osteocytes (time frame: Up to 4 years). 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 8 Sep 2023.