Multiple MyelomaPhase 1/2NCT05422027
Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma
A Phase 1/2 study testing Selinexor, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Xia Zhongjun at 4 sites in China.
Trial summary
This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose… 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?
- Selinexor, Bortezomib and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesChina
- Study dates
- 25 Jul 2022to 31 Dec 2025
- Phase
- Phase 1/2
- 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
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Willing and able to written informed consent (ICF) .
- Age ≥ 18 years.
- Newly diagnosed multiple myeloma as defined by IMWG(Rajkumar, Dimopoulos et al. 2014) , measurable disease as defined IMWG 2016 criteria(Table 5) (Kumar, Paiva et al.2016), and meet at least one of the following criteria:
- Serum M-protein (SPEP) ≥ 5 g/L, If the MM type is IgA/IgD, that can be substituted by IgA/IgD quantitative level.
- 24 hours-Urinary M-protein excretion ≥ 0.2 g (200 mg)
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- Serum FLC ≥ 100 mg/L with abnormal FLC ratio ( FLC Normal ratio:0.26 to 1.65)
- According to mSMART 3.0 definition for high risk multiple myeloma:
- High Risk genetic Abnormalities t(4;14) , t(14;16) , t(14;20) , Del 17p, p53 mutation, Gain 1q
- R-ISS Stage 3
- High Plasma Cell S-phase
- GEP: High risk signature
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. ECOG PS 3 allowed, if caused by myeloma.
- Patients must have received no prior chemotherapy for multiple myeloma. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Patients must have received no prior steroid treatment for myeloma with the exception of a maximum of 14 days of treatment for symptom control.
- Adequate hepatic function: total bilirubin < 1.5× upper limit of normal (ULN) (for patients with Gilbert's syndrome, a total bilirubin of < 3× ULN is required), AST < 2× ULN, and ALT < 2× ULN.
- Adequate renal function: estimated creatinine clearance ≥ 30 mL/min (calculated using the formula of Cockroft-Gault).
- Adequate hematopoietic function within 7 days prior to C1D1 and met the following criteria: White blood cell (WBC) count ≥1.5×109/L, Absolute neutrophil count (ANC)≥1.0×109/L, Hemoglobin (HB) ≥85g/L and Platelet count (PLT) ≥75×109/L (patients whom <50% of bone marrow nucleated cells are plasma cells) or PLT ≥ 50×109/L (patients whom ≥ 50% of bone marrow nucleated cells are plasma cells).
- Patients could not receive hematopoietic growth factor treatment within 2 weeks prior to screening, These growth factors include Erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), Granulocyte macrophages-colony stimulating factor (GM-CSF), Platelet agonist, etc (Eltrombopag, Thrombopoietin (TPO), Interleukin-11).
- Patients receive transfusions of blood products:
- At least 2 weeks elapsed between the screening hemoglobin assessment and the last red blood cell infusion,
- And at least 1 week elapsed between the screening platelet assessment and the last platelet infusion.
- Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.
- Female patients of childbearing potential must meet below two criteria:
- must agree to use effective contraception methods since signature in ICF, throughout the study and for 3 months following the last dose of study treatment.
- must have a negative serum pregnancy test at screening. Note: A woman is considered of childbearing potential following menarche and until becoming postmenopausal (defined as no menstrual period for a minimum of 12 months) or permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy). A woman who is taking oral contraceptive or using intrauterine device is considered of childbearing potential.
- Male patients (including those who have received vasectomy) must use a condom if sexually active with a female of child-bearing potential throughout the study and for 3 months following the last dose of study treatment.
Who cannot join
- Patients who meet any of the following criteria will not be enrolled:
- Plasma cell leukemia.
- Documented active amyloidosis.
- Involvement of the central nervous system(CNS) by Multiple myeloma.
- Prior exposure to a SINE compound, including ATG-010.
- Currently, whether or not the patient is on medication, > Grade 2 peripheral neuropathy or ≥ Grade ≥ 2 painful neuropathy at baseline.
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- Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide, and Selinexor (ATG-010) .
- Active, unstable cardiovascular function, as indicated by the presence of:
- Symptomatic ischemia, or
- Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or
- Congestive heart failure of New York Heart Association Class ≥3 or known left ventricular ejection fraction <40%, or
- Myocardial infarction within 6 months prior to C1D1.
- Known positive serology for HIV or HIV seropositivity.
- Known active hepatitis A, B, or C infection; eg. positive for HCV RNA or HBV-DNA.
- Women who are pregnant or nursing.
- Life expectancy of less than 6 months.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Has any concurrent diseases or complications that is likely to interfere with the study procedures.
- Patients unwilling or unable to comply with the protocol.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510000
Liye Zhong, Ph.D
- Recruiting
Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,
Guangzhou, Guangdong, 510060
Zhong-jun Xia, Ph.D, +86 020-87342439, xiazhj@sysucc.org.cn
Zhong-jun Xia, M.D.
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Xiuju Wang, Ph.D
Xiuju Wang, Ph.D
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Yongqiang Wei, PhD
Yongqiang Wei, PhD
About this study
Official title: Selinexor(ATG-010) Plus Bortezomib, Lenalidomide and Dexamethasone (XVRd) in High Risk Newly Diagnosed Multiple Myeloma
This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.The enrollment period for this study is expected to be approximately 12 months.
The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Read the detailed description
This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma. Approximately 3-42 patients will be enrolled in the study. In dose escalation phase, patients with high-risk NDMM will be treated with VRd standard regimen (bortezomib 1.3mg/m2 SC on day1,4,8,11, lenalidomide 25 mg on day 1-14 and dexamethasone 40mg on day 1,8,15 in a 21-day cycle) plus escalating doses of selinexor 40 mg or 60 mg on days 1, 8, and 15 of each cycle in a 3+3 design. The primary objective of the dose escalation study is to determine the safety, tolerability,and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability. All of the patients will receive 12 cycles of XVRd , and subjects can choose maintenance treatment with XR after 12 cycles of XVRd.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.
The enrollment period for this study is expected to be approximately 12 months. The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
- Conditions
- Multiple Myeloma
- Being tested
- Selinexor, Bortezomib, Lenalidomide, Dexamethasone
- Keywords
- Selinexor, ATG-010, Newly Diagnosed, High Risk
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called ATG-010, Xpovio
Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
Selinexor dose escalation: 40, 60mg respectively on day 1,8,15 for 21 days cycles
BortezomibDrug
Also called Velcade
The investigators gave patients subcutaneous bortezomib 1.3mg/sqm on days 1, 8,15 of a 21- day cycle.
standard bortezomib-lenalidomide-dexamethasone
LenalidomideDrug
Also called Revlimid
The investigators gave patients oral lenalidomide 25mg on days 1 to 14 of a 21-day cycle.
standard bortezomib-lenalidomide-dexamethasone
DexamethasoneDrug
Also called Dexamethasone Acetate
The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 of a 21-day cycle.
standard bortezomib-lenalidomide-dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Selinexor-VRd（XVRd） | Experimental | bortezomib SC 1.3mg/sqm on day 1,4,8,11, lenalidomide oral 25 mg on day 1-14, and dexamethasone 40mg on day 1,8,15 in a 21-day cycle; Selinexor dose escalation: 40，60mg respectively on day 1,8,15 for 21-days cycles. Then Selinexor will be given at the recommended dose level on phase II. Receives: Drug: Selinexor; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Maximum Tolerated Dose (MTD)
The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern.
Measured: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ;
Dose Escalation: Recommended Phase 2 Does (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.
Measured: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ;
Dose Expansion: MRD negative remission
MRD negative remission (<10-5) as defined by IMWG consensus
Measured: At any time up to 12 months after XVRD treatment
Secondary outcomes (7)
complete response (CR)
complete response (CR) and stringent complete response (sCR)
Measured: Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a VGPR, CR or PR (up to 12 cycles)
Overall Survival (OS)
Occurrence of death regardless of cause
Measured: 12 months
Progression-Free Survival (PFS)
Duration from start of study treatment to PD or death (regardless of cause), whichever comes first
Measured: 12 months
Duration of Response (DOR)
Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first
Measured: 12 months
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR=ORR+Minor Response [MR])
Measured: 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR=CBR+Stable Disease[SD; for a minimum of 12 weeks])
Measured: 12 months
Number of Participants with Adverse Events
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measured: From first dose of study drug administration to end of treatment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start25 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xia Zhongjun
- Sponsor type
- University, hospital or other
- Collaborators
- Antengene Corporation
- Responsible party
- Sponsor-investigator, Xia Zhongjun, Sun Yat-sen University
- Investigators
- Zhongjun Xia, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422027
- Sponsor's protocol ID
- ATG-010-IIT-MM-005
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD results are used for publication,and can be shared with other investigators and sponsors
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selinexor(ATG-010) Plus Bortezomib, Lenalidomide and Dexamethasone (XVRd) in High Risk Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05422027
- Acronym / sponsor ID
- ATG-010-IIT-MM-005
- Conditions
- Multiple Myeloma
- Keywords
- Selinexor, ATG-010, Newly Diagnosed, High Risk
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Xia ZhongjunUniversity, hospital or other
- Collaborators
- Antengene Corporation
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 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 a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.The enrollment period for this study is expected to be approximately 12 months.
The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Detailed description
This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma. Approximately 3-42 patients will be enrolled in the study. In dose escalation phase, patients with high-risk NDMM will be treated with VRd standard regimen (bortezomib 1.3mg/m2 SC on day1,4,8,11, lenalidomide 25 mg on day 1-14 and dexamethasone 40mg on day 1,8,15 in a 21-day cycle) plus escalating doses of selinexor 40 mg or 60 mg on days 1, 8, and 15 of each cycle in a 3+3 design. The primary objective of the dose escalation study is to determine the safety, tolerability,and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability. All of the patients will receive 12 cycles of XVRd , and subjects can choose maintenance treatment with XR after 12 cycles of XVRd.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.
The enrollment period for this study is expected to be approximately 12 months. The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor-VRd（XVRd） | Experimental | Drug: Selinexor, Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasonebortezomib SC 1.3mg/sqm on day 1,4,8,11, lenalidomide oral 25 mg on day 1-14, and dexamethasone 40mg on day 1,8,15 in a 21-day cycle; Selinexor dose escalation: 40，60mg respectively on day 1,8,15 for 21-days cycles. Then Selinexor will be given at the recommended dose level on phase II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- Male patients (including those who have received vasectomy) must use a condom if sexually active with a female of child-bearing potential throughout the study and for 3 months following the last dose of study treatment.
Key exclusion criteria (21 listed)
- Patients who meet any of the following criteria will not be enrolled:
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 |
|---|---|---|
| SelinexorAlso: ATG-010, XpovioSelinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor dose escalation: 40, 60mg respectively on day 1,8,15 for 21 days cycles | Drug | Selinexor-VRd（XVRd） |
| BortezomibAlso: VelcadeThe investigators gave patients subcutaneous bortezomib 1.3mg/sqm on days 1, 8,15 of a 21- day cycle. standard bortezomib-lenalidomide-dexamethasone | Drug | Selinexor-VRd（XVRd） |
| LenalidomideAlso: RevlimidThe investigators gave patients oral lenalidomide 25mg on days 1 to 14 of a 21-day cycle. standard bortezomib-lenalidomide-dexamethasone | Drug | Selinexor-VRd（XVRd） |
| DexamethasoneAlso: Dexamethasone AcetateThe investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 of a 21-day cycle. standard bortezomib-lenalidomide-dexamethasone | Drug | Selinexor-VRd（XVRd） |
Primary outcome
Dose Escalation: Maximum Tolerated Dose (MTD)
Time frame: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ;
The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern.
Dose Escalation: Recommended Phase 2 Does (RP2D)
Time frame: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ;
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.
Dose Expansion: MRD negative remission
Time frame: At any time up to 12 months after XVRD treatment
MRD negative remission (<10-5) as defined by IMWG consensus
7 secondary outcomes
complete response (CR)
Time frame: Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a VGPR, CR or PR (up to 12 cycles)
Overall Survival (OS)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Duration of Response (DOR)
Time frame: 12 months
Clinical Benefit Rate (CBR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Number of Participants with Adverse Events
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Yes. All IPD results are used for publication,and can be shared with other investigators and sponsors
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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.
Zhongjun Xia, Ph.D principal investigator
Sun Yat-sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selinexor, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Xia Zhongjun at 4 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 26 inclusion and 21 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongjun Xia, Ph.D (+86-020-87342438, xiazhj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Maximum Tolerated Dose (MTD) (time frame: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ;). The study lists 3 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 Jun 2024.