Refractory Multiple MyelomaPhase 2NCT03731832
Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing MLN9708, Pomalidomide 4 MG Oral Capsule and Dexamethasone in people with Refractory Multiple Myeloma, run by GWT-TUD GmbH at 11 sites in Germany.
Trial summary
The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma
- What is being tested?
- MLN9708, Pomalidomide 4 MG Oral Capsule and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesGermany
- Study dates
- 20 Sep 2018to 22 Apr 2024
- Phase
- Phase 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
- Male or female patients ≥ 18 years of age at the time of signing the informed consent form
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study has been obtained prior to any study related assessments/ procedures being conducted
- Patients with relapsed or refractory, histologically confirmed multiple myeloma
- Patients must have received at least two but not more than four prior anti-myeloma regimens including lenalidomide and bortezomib and have demonstrated disease progression on the last therapy
- Prior treatments must have included both lenalidomide and bortezomib: at least two consecutive cycles of lenalidomide and bortezomib (alone or in combination) and adequate prior alkylator exposure. This is either as part of a stem cell transplant or at least 6 consecutive cycles of an alkylator-based therapy.
- Patients must have failed bortezomib and lenalidomide therapy: progression within 60 days; PR or better with progression within 6 month and/or bortezomib intolerant after ≥ 2 cycles and achieving ≤ MR
Show all 32Show fewer
- Relapsed from or refractory to at least one regimen (induction, autologous stem cell transplantation (or allogenic stem cell transplantation) and consolidation/maintenance are considered one "regimen")
- Measurable levels of serum and/or urine M-protein: serum M-protein ≥ 5 g/L and/or urine M-protein ≥ 200 mg/24h or serum free light chain (sFLC) concentration of > 100 mg/L of the involved FLC, provided sFLC ratio is abnormal (sFLC K/λ ratio (< 0.26 or > 1.65)
- Life expectancy ≥ 3 months
- ECOG performance status of 0, 1, or 2
- Patients must be able to adhere to the study visit schedule and other protocol requirements
- All women and men must acknowledge to have understood the hazards and necessary precautions associated with the use of pomalidomide and ixazomib
- All subjects must agree in writing to strictly adhere to the Pomalidomide Pregnancy Prevention Plan as given in Appendix C
- Females of childbearing potential (FCBP) must:
- Understand the potential teratogenic risk to the unborn child
- Agree to utilize two reliable forms of contraception simultaneously without interruption for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 90 days after study treatment discontinuation
- Be capable of complying with effective contraceptive measures
- Be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
- Understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
- Understand the need and accept to undergo pregnancy testing based on the frequency outlined in this protocol
- Females must agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation
- Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 90 days following discontinuation from this study, even if he has undergone a successful vasectomy
- Males must also agree to refrain from donating semen or sperm while on the study drugs and for 90 days after discontinuation from this study treatment
- Subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment
- Subjects must agree not to share medication
- Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) 1 x 109/L
- Platelet count 75 x 109/L for patients in whom < 50% of bone marrow nucleated cells are plasma cells
- Platelet count ≥ 30 x 109/L for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells. (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment)
- Total bilirubin 1.5 the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 ULN
- Calculated creatinine clearance 30 mL/min
Who cannot join
- Concomitant cancer chemo- or radiotherapy (except for local radiation therapy for preexisting lytic lesions)
- Treatment with any investigational product within 60 days prior to first administration of pomalidomide and ixazomib
- Patients eligible for autologous and / or allogeneic stem cell transplantation
- Abnormal/inadequate organ or bone marrow function as defined below (any single parameter to fulfill condition): ANC < 1 x 109/L
- Hemoglobin < 8.0 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted)
- Platelet count < 75 x 109/L for patients in whom < 50% of bone marrow nucleated cells are plasma cells
Show all 24Show fewer
- Platelet count < 30 x 109/L for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- Estimated GFR (MDRD) < 45 ml/min
- AST/ALT > 3 x upper limit of normal (ULN)
- Serum (total) bilirubin > 1.5 x ULN
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L); or free ionized calcium > 6.5 mg/dL (> 1.6 mmol/L)
- Serum creatinine > 1.5 x ULN
- Prior pomalidomide based therapy
- Prior ixazomib based therapy
- Baseline peripheral neuropathy > Grade 1 on clinical examination within 14 days before enrollment
- Active HIV, hepatitis B (including patients who are tested Anti-HBc-positive and / or HBsAg-positive) or hepatitis C infection after serologic testing
- Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
- Known hypersensitivity to pomalidomide and its analogues in general and/or to ixazomib and its analogues or to any other component of study drugs
- Prior malignancy excluding adequately treated with curative intent basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer without any evidence of residual disease or requiring anti-cancer treatment < 2 years prior to initiating study treatment
- Patients with congestive heart failure NYHA Class III and IV, cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter, bundle brunch block) or other signs and symptoms of relevant cardiovascular disease
- Pregnant women, nursing mothers, lactating women, and women of childbearing potential as well as male subjects who are unwilling to adhere to the guidelines of the treatment-specific pregnancy prevention program
- Unwilling or unable to follow protocol requirements
- Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of the study drugs including difficulty swallowing
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg
Aschaffenburg, 63739
Sozialstiftung Bamberg / Klinik am Bruderwald, Zentrum für Innere Medizin, Med. Klinik V, Hämatologie und internistische Onkologie
Bamberg, 96049
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, 60590
Universitätsklinikum Jena / Klinik für Innere Medizin II, Abteilung für Hämatologie und internistische Onkologie
Jena, 07747
Universitätsklinikum Magdeburg A.Ö.R / Klinik für Hämatologie und Onkologie
Magdeburg, 39120
Klinikum rechts der Isar der TU München / III. Med. Klinik und Poliklinik
Munich, Bavaria, 81675
Universitätsklinikum Münster / Medizinische Klinik A
Münster, 48149
Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212
Universitätsklinikum Ulm / Klinik für Innere Medizin III
Ulm, 89081
Universitätsklinikum Würzburg
Würzburg, 97080
About this study
Official title: Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma
The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.
Read the detailed description
The study is designed as an open-label, non-randomized, multicenter study to investigate the clinical activity of pomalidomide administered once daily in combination with oral ixazomib and dexamethasone (PId) until disease progression according to IMWG criteria.
Patients with clinical relapse (any one of the following: deterioration of renal function, hypercalcemia, newly developing osteolytic lesions and/or soft tissue plasmacytomas) will go off study and receive further treatment according to their treating physician. Patients with isolated biochemical relapse with an increase of serum M-protein of ≥ 25% (absolute increase in serum must be ≥ 5 g/L) and/or urine M-protein (absolute increase in urine must be ≥ 200 mg/24h) or in the difference between involved and uninvolved FLC levels (provided, the absolute increase is > 100 mg/L) without further signs or symptoms will proceed to the intensification phase (PICd).
The intensification phase (PICd) will last until further disease progression. In case of significant haematological and non-haematological toxicities, dose adjustments and/or interruption of the study drugs may be necessary.
Response assessments will be performed every four weeks by evaluation of serum and 24 hour urine specimens. "Progressive disease" (PD) will require a consecutive confirmatory measurement.
- Conditions
- Refractory Multiple Myeloma
- Being tested
- MLN9708, Pomalidomide 4 MG Oral Capsule, Dexamethasone, Cyclophosphamide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN9708Drug
Also called Ixazomib 4.0 mg
Study drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle
Pomalidomide 4 MG Oral CapsuleDrug
Study drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle.
DexamethasoneDrug
Dexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule.
CyclophosphamideDrug
Cyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| PId | Experimental | Treatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression. Receives: Drug: MLN9708; Drug: Pomalidomide 4 MG Oral Capsule; Drug: Dexamethasone |
| PICd | Experimental | Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. Receives: Drug: MLN9708; Drug: Pomalidomide 4 MG Oral Capsule; Drug: Dexamethasone; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response rate (PId) according to the IMWG criteria.
Overall response rate at PId
Measured: 1 year throughout study completion
Secondary outcomes (6)
Disease control rate
Disease control rate in patients receiving PId (at least SD)
Measured: 1 year throughout study completion
Overall response rate
Overall response rate (PR or better) for patients intensified with PICd
Measured: 1 year throughout study completion
Disease control rate in patients intensified with PICd (at least SD)
Disease control rate in patients intensified with PICd (at least SD)
Measured: 1 year throughout study completion
Progression-free survival (PFS)
Progression-free survival (PFS) for patients receiving PId and for patients receiving PICd
Measured: 1 year throughout study completion
Overall survival (OS)
Overall survival (OS)
Measured: 1 year throughout study completion
Subsequent anti-myeloma regimens (including best response)
Best response during induction by PId
Measured: 1 year throughout study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start20 Sep 2018
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All patients receive PId. Patients showing a biochemical relapse receive PICd afterwards, while patients showing a clinical relapse go off study.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Knop, Prof., Principal investigator, Universitätsklinikum Würzburg / Medizinische Klinik und Poliklinik II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731832
- Sponsor's protocol ID
- DSMM XV
- Status last verified
- Sep 2025
- First submitted
- 1 Oct 2018
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03731832
- Acronym / sponsor ID
- DSMM XV
- Conditions
- Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 6 Nov 2018 (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 study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.
Detailed description
The study is designed as an open-label, non-randomized, multicenter study to investigate the clinical activity of pomalidomide administered once daily in combination with oral ixazomib and dexamethasone (PId) until disease progression according to IMWG criteria.
Patients with clinical relapse (any one of the following: deterioration of renal function, hypercalcemia, newly developing osteolytic lesions and/or soft tissue plasmacytomas) will go off study and receive further treatment according to their treating physician. Patients with isolated biochemical relapse with an increase of serum M-protein of ≥ 25% (absolute increase in serum must be ≥ 5 g/L) and/or urine M-protein (absolute increase in urine must be ≥ 200 mg/24h) or in the difference between involved and uninvolved FLC levels (provided, the absolute increase is > 100 mg/L) without further signs or symptoms will proceed to the intensification phase (PICd).
The intensification phase (PICd) will last until further disease progression. In case of significant haematological and non-haematological toxicities, dose adjustments and/or interruption of the study drugs may be necessary.
Response assessments will be performed every four weeks by evaluation of serum and 24 hour urine specimens. "Progressive disease" (PD) will require a consecutive confirmatory measurement.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients receive PId. Patients showing a biochemical relapse receive PICd afterwards, while patients showing a clinical relapse go off study.
| Arm | Type | Receives |
|---|---|---|
| PId | Experimental | Drug: MLN9708, Drug: Pomalidomide 4 MG Oral Capsule, Drug: DexamethasoneTreatment of eligible patients with combination of Pomalidomide, Ixazomib, Dexamethasone for all patients until disease progression. |
| PICd | Experimental | Drug: MLN9708, Drug: Pomalidomide 4 MG Oral Capsule, Drug: Dexamethasone, Drug: CyclophosphamideTreatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Male or female patients ≥ 18 years of age at the time of signing the informed consent form
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study has been obtained prior to any study related assessments/ procedures being conducted
- Patients with relapsed or refractory, histologically confirmed multiple myeloma
- Patients must have received at least two but not more than four prior anti-myeloma regimens including lenalidomide and bortezomib and have demonstrated disease progression on the last therapy
- Prior treatments must have included both lenalidomide and bortezomib: at least two consecutive cycles of lenalidomide and bortezomib (alone or in combination) and adequate prior alkylator exposure. This is either as part of a stem cell transplant or at least 6 consecutive cycles of an alkylator-based therapy.
Key exclusion criteria (24 listed)
- Concomitant cancer chemo- or radiotherapy (except for local radiation therapy for preexisting lytic lesions)
- Treatment with any investigational product within 60 days prior to first administration of pomalidomide and ixazomib
- Patients eligible for autologous and / or allogeneic stem cell transplantation
- Abnormal/inadequate organ or bone marrow function as defined below (any single parameter to fulfill condition): ANC < 1 x 109/L
- Hemoglobin < 8.0 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted)
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 |
|---|---|---|
| MLN9708Also: Ixazomib 4.0 mgStudy drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle | Drug | PICd, PId |
| Pomalidomide 4 MG Oral CapsuleStudy drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle. | Drug | PICd, PId |
| DexamethasoneDexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule. | Drug | PICd, PId |
| CyclophosphamideCyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle. | Drug | PICd |
Primary outcome
Overall Response rate (PId) according to the IMWG criteria.
Time frame: 1 year throughout study completion
Overall response rate at PId
6 secondary outcomes
Disease control rate
Time frame: 1 year throughout study completion
Overall response rate
Time frame: 1 year throughout study completion
Disease control rate in patients intensified with PICd (at least SD)
Time frame: 1 year throughout study completion
Progression-free survival (PFS)
Time frame: 1 year throughout study completion
Overall survival (OS)
Time frame: 1 year throughout study completion
Subsequent anti-myeloma regimens (including best response)
Time frame: 1 year throughout study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Stefan Knop, Prof. principal investigator
Universitätsklinikum Würzburg / Medizinische Klinik und Poliklinik II
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLN9708, Pomalidomide 4 MG Oral Capsule and Dexamethasone in people with Refractory Multiple Myeloma, run by GWT-TUD GmbH at 11 sites in Germany.
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 32 inclusion and 24 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: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (PId) according to the IMWG criteria. (time frame: 1 year throughout study completion). 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 2025.