Newly Diagnosed Multiple MyelomaNCT05561049
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma
An observational study of Newly Diagnosed Multiple Myeloma, run by The First Affiliated Hospital of Soochow University.
Trial summary
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 1. newly diagnosed MM; 2. age over 18 years, male or female; 3. glomerular filtration rate (eGFR) < 40 mL/min 4. patients who completed at least one course of treatment were included in the safety observation; 5. Patients who completed at least 2 courses of treatment were included in the efficacy observation;
Who may be able to join
- newly diagnosed multiple myeloma;
- age over 18 years, male or female;
- glomerular filtration rate (eGFR) < 40 mL/min
- Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
- patients who completed at least one course of treatment were included in the safety observation;
- Patients who completed at least 2 courses of treatment were included in the efficacy observation;
Who cannot join
- acute and chronic renal insufficiency not caused by myeloma;
- are receiving any other investigational drug or investigational medical device;
- Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
- patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;
About this study
Official title: Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone RegimensDrug
Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
What is being measured
The primary outcome is the main question the study is designed to answer.
Very good partial response (VGPR) rate
Measured: 28 days after consolidation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561049
- Sponsor's protocol ID
- D-VTD-MM07
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT05561049
- Acronym / sponsor ID
- D-VTD-MM07
- Conditions
- Newly Diagnosed Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 Sep 2022 (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.
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. newly diagnosed MM; 2. age over 18 years, male or female; 3. glomerular filtration rate (eGFR) < 40 mL/min 4. patients who completed at least one course of treatment were included in the safety observation; 5. Patients who completed at least 2 courses of treatment were included in the efficacy observation;
Key inclusion criteria (6 listed)
- newly diagnosed multiple myeloma;
- age over 18 years, male or female;
- glomerular filtration rate (eGFR) < 40 mL/min
- Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
- patients who completed at least one course of treatment were included in the safety observation;
Key exclusion criteria (4 listed)
- acute and chronic renal insufficiency not caused by myeloma;
- are receiving any other investigational drug or investigational medical device;
- Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
- patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;
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 |
|---|---|---|
| Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone RegimensDaratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens | Drug | – |
Primary outcome
Very good partial response (VGPR) rate
Time frame: 28 days after consolidation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Multiple Myeloma, run by The First Affiliated Hospital of Soochow University.
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 6 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Very good partial response (VGPR) rate (time frame: 28 days after consolidation therapy). 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 30 Sep 2022.