Multiple MyelomaNCT04678089
Evaluation of Clinical Treatment of Multiple Myeloma Based on Multi-omics
An observational study of Multiple Myeloma and Bortezomib, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Bortezomib
- What is being tested?
- Bortezomib
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2019to Dec 2023
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality. The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. There is no distinction between age, gender and nationality.
Who may be able to join
- exposure group:
- Patients diagnosed with multiple myeloma.
- Patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results.
- healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.
Who cannot join
- Patients without complete clinical information.
- Patients with malignant epidemic diseases.
- Patients with alcohol abuse or special dietary habit .
- Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.
- Patients with a history of gastrointestinal operation.
- Patients with severe renal insufficiency without regular dialysis.
- Patients with other possibilities who has severe liver or kidney function injury without intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Study of Clinical Treatment of Multiple Myeloma Based on Analytical Omics
With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy.
In this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. It is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. If the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. Investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.
- Conditions
- Multiple Myeloma, Bortezomib
- Being tested
- Bortezomib
- Keywords
- Genomics, Metabonomics, therapeutic drug monitoring
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called PS-341, VELCADE
Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc
| Study group | Role | What they receive |
|---|---|---|
| Health group | The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. Also，we need some healthy volunteers. Healthy volunteers refer to people without serious physical disease, immune disease and family history of mental illness.There is no distinction between age, gender and nationality. | |
| Multiple Myeloma group | In the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment toxicities:neuritis
Measured: From registration to December,2022
Confirmed responses: Strictly Complete response, sCR
Measured: From registration to December,2022
Confirmed responses: Complete response, CR
Measured: From registration to December,2022
Confirmed responses: Very good partial response, VGPR
Measured: From registration to December,2022
Confirmed responses: Partial response, PR
Measured: From registration to December,2022
Confirmed responses: Minimal remission, MR
Measured: From registration to December,2022
Confirmed responses: Stable disease, SD
Measured: From registration to December,2022
Progressive disease, PD
Measured: From registration to December,2022
Secondary outcomes (2)
Progression-free survival
Measured: From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022
Overall survival
Measured: From registration to death due to any cause, assessed up to December,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start16 May 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by Beijing Chao Yang 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lihong Liu, Beijing Chao Yang Hospital
- Investigators
- Lihong Liu, Doctor, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678089
- Sponsor's protocol ID
- 2020-9-23-7
- Status last verified
- Apr 2022
- First submitted
- 19 Nov 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Study of Clinical Treatment of Multiple Myeloma Based on Analytical Omics
- ClinicalTrials.gov ID
- NCT04678089
- Acronym / sponsor ID
- 2020-9-23-7
- Conditions
- Multiple Myeloma, Bortezomib
- Keywords
- Genomics, Metabonomics, therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Dec 2020 (actual)
- 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.
With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy.
In this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. It is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. If the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. Investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health group | – | –The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. Also，we need some healthy volunteers. Healthy volunteers refer to people without serious physical disease, immune disease and family history of mental illness.There is no distinction between age, gender and nationality. |
| Multiple Myeloma group | – | Drug: BortezomibIn the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality. The healthy control group mainly collected patients with other chronic diseases or blood tumors who did not meet the exclusion criteria and were not diagnosed with multiple myeloma. There is no distinction between age, gender and nationality.
Key inclusion criteria (4 listed)
- exposure group:
- healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.
Key exclusion criteria (7 listed)
- Patients without complete clinical information.
- Patients with malignant epidemic diseases.
- Patients with alcohol abuse or special dietary habit .
- Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.
- Patients with a history of gastrointestinal operation.
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 |
|---|---|---|
| BortezomibAlso: PS-341, VELCADEObjective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc | Drug | Multiple Myeloma group |
Primary outcome
Treatment toxicities:neuritis
Time frame: From registration to December,2022
Confirmed responses: Strictly Complete response, sCR
Time frame: From registration to December,2022
Confirmed responses: Complete response, CR
Time frame: From registration to December,2022
Confirmed responses: Very good partial response, VGPR
Time frame: From registration to December,2022
Confirmed responses: Partial response, PR
Time frame: From registration to December,2022
Confirmed responses: Minimal remission, MR
Time frame: From registration to December,2022
Confirmed responses: Stable disease, SD
Time frame: From registration to December,2022
Progressive disease, PD
Time frame: From registration to December,2022
2 secondary outcomes
Progression-free survival
Time frame: From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022
Overall survival
Time frame: From registration to death due to any cause, assessed up to December,2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
Lihong Liu, Doctor principal investigator
Beijing Chao Yang Hospital
1 site 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 and Bortezomib, run by Beijing Chao Yang Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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 China. 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?
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?
Treatment toxicities:neuritis (time frame: From registration to December,2022). The study lists 8 primary outcomes in all. 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 28 Apr 2022.