Multiple MyelomaNCT06497738
A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
An observational study of Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University at 6 sites in China.
Trial summary
The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 112 participants
- Where
- 6 sitesChina
- Study dates
- 1 May 2024to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 1. Age ≥ 65 years old 2. Newly diagnosed Multiple myeloma patients
Who may be able to join
- Age ≥ 65 years old
- Newly diagnosed Multiple myeloma patients with measurable disease. Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria：Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or SLiM. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT. SLiM: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies.
- Measurable disease: Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
- Expected survival more than 3 months
- No active infectious disease
- Be able to understand the characteristics of the disease, voluntarily join this study protocol for treatment and follow-up
- Have signed informed consent. Informed consent was obtained from the patients themselves or their immediate family members.
Who cannot join
- Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases.
- Peripheral neuropathy or neuropathic pain(except extramedullary disease compression) Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
- Plasma cell leukemia, non-bone-related extramedullary lesions
- Severe thrombotic events before treatment
- The presence of grade 2 or higher peripheral neuropathy before treatment
- Liver dysfunction (alanine aminotransferase and aspartate aminotransferase ≥ 2.5 times the upper limit of normal value)
Show all 14Show fewer
- Total bilirubin ≥ 1.5 times the upper limit of normal value
- Major surgery within 30 days before enrollment
- Epilepsy, dementia and other mental abnormalities requiring drug treatment and cannot understand or follow the study protocol
- According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness that may interfere with the participation in this clinical study
- Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results
- Patients who are receiving other experimental drug treatment
- Lactating or pregnant women
- The investigator believes that the participant is not suitable for enrollment
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213000
Xuzhang Lu, luxuzhang2008@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Yuanyuan Jin, 025-68306091, 827508088@qq.com
- Recruiting
Nanjing First People's Hospital
Nanjing, Jiangsu, 21000
Xuezhong Zhang, zxuezhong1968@sina.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Hongming Huang, HHMing2008@163.com
- Recruiting
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Jianfeng Zhu, zhjf248825755@sina.com
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu, 224006
Yuexin Cheng, ycyycyx68@163.com
About this study
Official title: A Prospective, Multi-center, Open-label, Cohort Study to Compare Daratumumab-Lenalidomide-Dexamethasone (DRd) With Modified Bortezomib-Lenalidomide-Dexamethasone (VRd-lite) in Elderly Newly Diagnosed Multiple Myeloma
The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma.
Read the detailed description
This is a prospective, open-label, multicentered cohort study. This study will evaluate elderly participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. All the eligible participants can be free to choose to receive either daratumumab lenalidomide and dexamethasone (DRd) or modified bortezomib lenalidomide and dexamethasone (VRd-lite). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (Cycle 7 to 8). Bortezomib will be administered subcutaneously 1.3 mg/m^2 weekly of each 28-day cycle for Cycles 1-8. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 20 mg twice a week for both treatment arms. Participants in both treatment arms will continue at least lenalidomide maintenance until disease progression or unacceptable toxicity.The primary endpoint will be progression-free survival (PFS) and percentage of participants with Negative Minimal Residual Disease (MRD). Participant safety will be assessed throughout the 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 |
|---|---|---|
| Daratumumab + lenalidomide + dexamethasone | Drug: Daratumumab Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks. The total induction cycle is 8. Drug: Lenalidomide Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 21 of each 28-day cycle. Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant>75, dexamethasone will be reduced to 10mg twice a week. Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive daratumumab combined with lenalidomide until progression. | |
| Modified Bortezomib+Lenalidomide+dexamethasone | Drug: Bortezomib Bortezomib 1.3 mg/m^2 will be administered by subcutaneous(SC) injection injection weekly on Days 1, 8, 15, 22 of each 21-day cycle for Cycles 1-8. Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant>75, dexamethasone will be reduced to 10mg twice a week. Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive bortezomib combined with lenalidomide until progression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as the duration from date of enrollment to either progression disease(PD) or death, whichever comes first. International Myeloma Working Group (IMWG) criteria for PD: Increase of 25 percentage (%) from lowest response value in any one of following: Serum M-component (absolute increase must be >= 0.5 g/dL) Urine M-component (absolute increase must be >=200 mg/24 hours), participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain(FLC) levels (absolute increase must be >10 mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell(PC)% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Measured: From enrollment to either disease progression or death whichever occurs first (approximately 5 years, or 8 years if the adaptive approach is decided at the interim)
MRD Negative Rate
Percentage of participants who have achieved MRD negative status will be assessed. MRD negativity will be evaluated as a potential surrogate for PFS and overall survival (OS) in multiple myeloma treatment.
Measured: First time reached VGPR, then12,18,24 Months and every 6 months
Secondary outcomes (5)
Very Good Partial Response (VGPR) or Better Rate
VGPR or better rate is defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours); CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.
Measured: Approximately 5 years
Overall Response Rate
ORR is defined as the percentage of participants who achieve partial response (PR) or better responses prior to subsequent anti-myeloma therapy in accordance with IMWG criteria, during or after the study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90 % or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
Measured: Up to the end of the study (approximately 5 years)
Duration of Response(DOR)
DOR is calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD, as defined in the IMWG evaluation before the start of any subsequent anti-myeloma therapy.
Measured: From initial documentation of response to the date of PD until approximately 5 years
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of the participant's death due to any cause.
Measured: From enrollment until the participant's death from any cause (up to approximately 5 years, or 8 years if the adaptive approach is decided at the interim)
Complete Response (CR) or Better Rate
CR or better rate is defined as the percentage of participants achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (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.
- 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lijuan Chen, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497738
- Sponsor's protocol ID
- DRd
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-label, Cohort Study to Compare Daratumumab-Lenalidomide-Dexamethasone (DRd) With Modified Bortezomib-Lenalidomide-Dexamethasone (VRd-lite) in Elderly Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06497738
- Acronym / sponsor ID
- DRd
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Jul 2024 (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.
The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma.
Detailed description
This is a prospective, open-label, multicentered cohort study. This study will evaluate elderly participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. All the eligible participants can be free to choose to receive either daratumumab lenalidomide and dexamethasone (DRd) or modified bortezomib lenalidomide and dexamethasone (VRd-lite). Daratumumab (16 milligram per kilogram [mg/kg]) will be administered weekly for first 8 weeks (Cycles 1 to 2) of treatment and then every other week for 16 weeks (Cycles 3 to 6), then every 4 weeks (Cycle 7 to 8). Bortezomib will be administered subcutaneously 1.3 mg/m^2 weekly of each 28-day cycle for Cycles 1-8. Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle, and dexamethasone will be administered at a dose of 20 mg twice a week for both treatment arms. Participants in both treatment arms will continue at least lenalidomide maintenance until disease progression or unacceptable toxicity.The primary endpoint will be progression-free survival (PFS) and percentage of participants with Negative Minimal Residual Disease (MRD). Participant safety will be assessed throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daratumumab + lenalidomide + dexamethasone | – | –Drug: Daratumumab Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks. The total induction cycle is 8. Drug: Lenalidomide Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 21 of each 28-day cycle. Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant>75, dexamethasone will be reduced to 10mg twice a week. Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive daratumumab combined with lenalidomide until progression. |
| Modified Bortezomib+Lenalidomide+dexamethasone | – | –Drug: Bortezomib Bortezomib 1.3 mg/m^2 will be administered by subcutaneous(SC) injection injection weekly on Days 1, 8, 15, 22 of each 21-day cycle for Cycles 1-8. Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant>75, dexamethasone will be reduced to 10mg twice a week. Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive bortezomib combined with lenalidomide until progression. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 1. Age ≥ 65 years old 2. Newly diagnosed Multiple myeloma patients
Key inclusion criteria (7 listed)
- Age ≥ 65 years old
- Newly diagnosed Multiple myeloma patients with measurable disease. Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria：Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or SLiM. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT. SLiM: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies.
- Measurable disease: Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200 milligram[mg]/24 hours[hrs]); OR IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR Light chain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
- Expected survival more than 3 months
- No active infectious disease
Key exclusion criteria (14 listed)
- Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases.
- Peripheral neuropathy or neuropathic pain(except extramedullary disease compression) Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
- Plasma cell leukemia, non-bone-related extramedullary lesions
- Severe thrombotic events before treatment
- The presence of grade 2 or higher peripheral neuropathy before treatment
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
Progression-free Survival (PFS)
Time frame: From enrollment to either disease progression or death whichever occurs first (approximately 5 years, or 8 years if the adaptive approach is decided at the interim)
PFS is defined as the duration from date of enrollment to either progression disease(PD) or death, whichever comes first. International Myeloma Working Group (IMWG) criteria for PD: Increase of 25 percentage (%) from lowest response value in any one of following: Serum M-component (absolute increase must be >= 0.5 g/dL) Urine M-component (absolute increase must be >=200 mg/24 hours), participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain(FLC) levels (absolute increase must be >10 mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell(PC)% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
MRD Negative Rate
Time frame: First time reached VGPR, then12,18,24 Months and every 6 months
Percentage of participants who have achieved MRD negative status will be assessed. MRD negativity will be evaluated as a potential surrogate for PFS and overall survival (OS) in multiple myeloma treatment.
5 secondary outcomes
Very Good Partial Response (VGPR) or Better Rate
Time frame: Approximately 5 years
Overall Response Rate
Time frame: Up to the end of the study (approximately 5 years)
Duration of Response(DOR)
Time frame: From initial documentation of response to the date of PD until approximately 5 years
Overall Survival (OS)
Time frame: From enrollment until the participant's death from any cause (up to approximately 5 years, or 8 years if the adaptive approach is decided at the interim)
Complete Response (CR) or Better Rate
Time frame: Approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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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.
Lijuan Chen study chair
The First Affiliated Hospital with Nanjing Medical University
6 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 The First Affiliated Hospital with Nanjing Medical University at 6 sites 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Jin, Doctor (+86-025-68306091, 827508088@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: From enrollment to either disease progression or death whichever occurs first (approximately 5 years, or 8 years if the adaptive approach is decided at the interim)). The study lists 2 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 17 Aug 2025.