Relapsed, Refractory, Multiple MyelomaPhase 1/2NCT04762745
The Efficacy and Safety of Pomalidomide and Bendamustine With Dexamethasone in Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing Pomalidomide, Bendamustine and Dexamethasone in people with Relapsed, Refractory, Multiple Myeloma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To explore the efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed, Refractory, Multiple Myeloma
- What is being tested?
- Pomalidomide, Bendamustine and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Feb 2021to Feb 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-75, no gender limitations.
- Ability of contraception during the experiment, no matter if they have suffered from infertility.
- Relapsed or refractory to prior lenalidomide or/and bortezomib(either in combination or sequential)therapy (i.e. history of progression on therapy or within 60 days after completion)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, life expectancy of more than 6 months.
- Measurable disease:
- Serum M protein > 10 g/L or Urine M protein ≥200 mg/24 hr or Elevated Free Light Chain per International Myeloma Working Group (IMWG) criteria, and abnormal ratio.
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- Absolute neutrophil count (ANC) >1.0 x 109/L or >1.0 x 109/L due to granulocyte/macrophage colony stimulating factor (GCSF and GMCSF), or if >50% marrow involvement, there is no limitations
- Platelet count >50.0 x 109/L or if >50% marrow involvement, there is no limitations.
- Total bilirubin ≤ 2.0mg/dL, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the upper limit of normal.
- Serum creatinine ≤2.0 mg/dL or creatinine clearance ≥60ml/min.
- Agree to take anticoagulant drugs, included but not limited to aspirin.
- Agree to sign the informed consent form.
Who cannot join
- Patients with known sensitivity to pomalidomide or bendamustine or dexamethasone and their accessories.
- Patients with primary systemic amyloidosis or monoclonal gammopathy of undetermined significance or smoldering multiple myeloma.
- Patients with active new thrombosis or disagree to take anticoagulant drugs, included but not limited to aspirin.
- Active treatment or intervention for other malignancy or need active treatment within 4 weeks of starting study treatment. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Central nervous system involvement.
- Systemic treatment with immunodepressants or steroids.
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- Ongoing or active systemic infection, active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure(NT-Pro-BNP≥1800pg/mL), unstable angina, or myocardial infarction within the past 6 months.
- Infection requiring systemic antibiotic therapy or other serious infection.
- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Psychiatric illness/social situation that would limit compliance with study requirements.
- Under other clinical trial procedures.
- Female patients who are lactating or pregnant.
- Other patients not appropriate for the trial in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Please Select, 510060
About this study
Official title: Department of Hematologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China
To explore the efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma
Read the detailed description
The trial has two parts: firstly, to explore the maximum tolerated dosage(MTD) of bendamustine in the combination of pomalidomide and dexamethasone in relapsed or refractory multiple myeloma; secondly, to find out efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma in an expanded cohort.
- Conditions
- Relapsed, Refractory, Multiple Myeloma
- Being tested
- Pomalidomide, Bendamustine, Dexamethasone
- Keywords
- pomalidomide, bendamustine, multiple myeloma
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called Pomalidomide( Anyue®, Chia Tai TIANQING, China)
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
BendamustineDrug
Also called Bendamustine( Leweixin®, Chia Tai TIANQING, China)
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 60mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
DexamethasoneDrug
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
PomalidomideDrug
Also called Pomalidomide( Anyue®, Chia Tai TIANQING, China)
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
BendamustineDrug
Also called Bendamustine( Leweixin®, Chia Tai TIANQING, China)
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
DexamethasoneDrug
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
PomalidomideDrug
Also called Pomalidomide( Anyue®, Chia Tai TIANQING, China)
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
BendamustineDrug
Also called Bendamustine( Leweixin®, Chia Tai TIANQING, China)
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
DexamethasoneDrug
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
PomalidomideDrug
Also called Pomalidomide( Anyue®, Chia Tai TIANQING, China)
Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 8 cycles. Then pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle until progression or intolerable toxicities.
BendamustineDrug
Also called Bendamustine( Leweixin®, Chia Tai TIANQING, China)
Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 8 cycles.
DexamethasoneDrug
Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 8 cycles. Then dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle until progression or intolerable toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Cohort 1 | Experimental | The combination of bendamustine, 60mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). Receives: Drug: Pomalidomide; Drug: Bendamustine; Drug: Dexamethasone |
| Phase I, Cohort 2 | Experimental | The combination of bendamustine, 70mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). Receives: Drug: Pomalidomide; Drug: Bendamustine; Drug: Dexamethasone |
| Phase I, Cohort 3 | Experimental | The combination of bendamustine, 80mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). Receives: Drug: Pomalidomide; Drug: Bendamustine; Drug: Dexamethasone |
| Phase II | Experimental | The combination of MTD dosage of bendamustine with pomalidomide and dexamethasone will be administrated in an expanded relapsed or refractory multiple myeloma cohorts for 8 cycles, then under the combination of pomalidomide and dexamethasone as maintenance therapy until progression or intolerable toxicities. Receives: Drug: Pomalidomide; Drug: Bendamustine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The number of patients achieving partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) after 8 cycles in phase II.
sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h.
PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required.
Measured: At the end of Cycle 8 in Phase II (each cycle is 28 days)
Secondary outcomes (3)
Complete response(CR) and stringent complete response(sCR) rate
The CR and sCR rate after 8 cycles in phase II.
CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Measured: At the end of Cycle 8 in Phase II (each cycle is 28 days)
Progression free survival(PFS)
The time relapsed for patients between initiation of study therapy and either disease progression or death
Measured: Through study completion, up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events during the study period as assessed by CTCAE v4.0
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed, Refractory, Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762745
- Sponsor's protocol ID
- RRMM-01
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Hematologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China
- ClinicalTrials.gov ID
- NCT04762745
- Acronym / sponsor ID
- RRMM-01
- Conditions
- Relapsed, Refractory, Multiple Myeloma
- Keywords
- pomalidomide, bendamustine, multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 21 Feb 2021 (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.
To explore the efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma
Detailed description
The trial has two parts: firstly, to explore the maximum tolerated dosage(MTD) of bendamustine in the combination of pomalidomide and dexamethasone in relapsed or refractory multiple myeloma; secondly, to find out efficacy and safety of pomalidomide and bendamustine with dexamethasone in relapsed or refractory multiple myeloma in an expanded cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I, Cohort 1 | Experimental | Drug: Pomalidomide, Drug: Bendamustine, Drug: DexamethasoneThe combination of bendamustine, 60mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). |
| Phase I, Cohort 2 | Experimental | Drug: Pomalidomide, Drug: Bendamustine, Drug: DexamethasoneThe combination of bendamustine, 70mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). |
| Phase I, Cohort 3 | Experimental | Drug: Pomalidomide, Drug: Bendamustine, Drug: DexamethasoneThe combination of bendamustine, 80mg/m2, with pomalidomide and dexamethasone will be administrated in 6 relapsed or refractory multiple myeloma patients for 1 cycle. If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD). |
| Phase II | Experimental | Drug: Pomalidomide, Drug: Bendamustine, Drug: DexamethasoneThe combination of MTD dosage of bendamustine with pomalidomide and dexamethasone will be administrated in an expanded relapsed or refractory multiple myeloma cohorts for 8 cycles, then under the combination of pomalidomide and dexamethasone as maintenance therapy until progression or intolerable toxicities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age of 18-75, no gender limitations.
- Ability of contraception during the experiment, no matter if they have suffered from infertility.
- Relapsed or refractory to prior lenalidomide or/and bortezomib(either in combination or sequential)therapy (i.e. history of progression on therapy or within 60 days after completion)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, life expectancy of more than 6 months.
- Measurable disease:
Key exclusion criteria (13 listed)
- Patients with known sensitivity to pomalidomide or bendamustine or dexamethasone and their accessories.
- Patients with primary systemic amyloidosis or monoclonal gammopathy of undetermined significance or smoldering multiple myeloma.
- Patients with active new thrombosis or disagree to take anticoagulant drugs, included but not limited to aspirin.
- Active treatment or intervention for other malignancy or need active treatment within 4 weeks of starting study treatment. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Central nervous system involvement.
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 |
|---|---|---|
| PomalidomideAlso: Pomalidomide( Anyue®, Chia Tai TIANQING, China)Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle. | Drug | Phase I, Cohort 1 |
| BendamustineAlso: Bendamustine( Leweixin®, Chia Tai TIANQING, China)Bendamustine( Leweixin®, Chia Tai TIANQING, China), 60mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 1 |
| DexamethasoneDexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 1 |
| PomalidomideAlso: Pomalidomide( Anyue®, Chia Tai TIANQING, China)Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle. | Drug | Phase I, Cohort 2 |
| BendamustineAlso: Bendamustine( Leweixin®, Chia Tai TIANQING, China)Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 2 |
| DexamethasoneDexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 2 |
| PomalidomideAlso: Pomalidomide( Anyue®, Chia Tai TIANQING, China)Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle. | Drug | Phase I, Cohort 3 |
| BendamustineAlso: Bendamustine( Leweixin®, Chia Tai TIANQING, China)Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 3 |
| DexamethasoneDexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle. | Drug | Phase I, Cohort 3 |
| PomalidomideAlso: Pomalidomide( Anyue®, Chia Tai TIANQING, China)Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 8 cycles. Then pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle until progression or intolerable toxicities. | Drug | Phase II |
| BendamustineAlso: Bendamustine( Leweixin®, Chia Tai TIANQING, China)Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 8 cycles. | Drug | Phase II |
| DexamethasoneDexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 8 cycles. Then dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle until progression or intolerable toxicities. | Drug | Phase II |
Primary outcome
Overall response rate
Time frame: At the end of Cycle 8 in Phase II (each cycle is 28 days)
The number of patients achieving partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) after 8 cycles in phase II. sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h. PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required.
3 secondary outcomes
Complete response(CR) and stringent complete response(sCR) rate
Time frame: At the end of Cycle 8 in Phase II (each cycle is 28 days)
Progression free survival(PFS)
Time frame: Through study completion, up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site 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 Pomalidomide, Bendamustine and Dexamethasone in people with Relapsed, Refractory, Multiple Myeloma, run by Sun Yat-sen University 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 12 inclusion and 13 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 21 Feb 2021. 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.
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?
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?
Overall response rate (time frame: At the end of Cycle 8 in Phase II (each cycle is 28 days)). 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 21 Feb 2021.