Multiple MyelomaPhase 2NCT06910124
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
A Phase 2 study testing Linvoseltamab and Lenalidomide in people with Multiple Myeloma, run by Dickran Kazandjian, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will: 1. Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Linvoseltamab 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 2 Dec 2032
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) documented initially prior to any treatment (Kumar et al., 2016).
- Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38).
- Documentation of receiving induction therapy with or without high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and receiving lenalidomide maintenance therapy ≤ 12 months.
- Cohort 1: at the time of assessment, the patient's current response is a partial response (PR), very good partial response (VGPR), or complete response (CR) but MRD+ by the FDA-cleared next-generation sequencing (NGS) Adaptive clonoseq assay.
- Cohort 2: at the time of assessment, the patient has a relapse from their initial complete response (CR) (<CR response are ineligible) post induction but do not meet criteria for IMWG progression (eg, patients who no longer meet criteria for CR but whose M-protein is ≤ 0.5 g/dL and/or immunofixation has turned positive, and/or have converted to MRD+ by the FDA-cleared NGS Adaptive clonoseq assay).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 3 (Appendix A)
Show all 16Show fewer
- Adequate organ function
- Absolute neutrophil count (ANC) ≥ 1000/microlitre (unless patient has ethnic neutropenia)
- Platelets ≥ 50,000/microlitre
- Hemoglobin ≥ 8 g/dL (transfusions permitted)
- Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 X ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) ≤ 3 X ULN
- Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or calculated estimated glomerular filtration rate (eGFR)/creatinine clearance (CrCl) (by Chronic Kidney Disease Epidemiology Collaboration, Modification of Diet in Renal Disease, or Cockcroft-Gault) ≥ 15 mL/min/1.73 m2
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 90 days following the last dose of study treatment.
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- Willing and able to comply with clinic visits and study-related procedures.
Who cannot join
- Patients who have received prior systemic therapies for Multiple Myeloma (MM) other than initial IMiD/PI/anti CD38/HDM-ASCT-based combination therapy.
- Treatment with corticosteroids for MM or other indications is permitted.
- Prior radiation therapy and surgery is permitted.
- Patients who are receiving any other investigational agents unless deemed not to interfere with the study by the Principal Investigator (PI).
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy.
Show all 23Show fewer
- Patient has any of the following:
- a. Human immunodeficiency virus (HIV)-positive with 1 or more of the following: i. History of acquired immune deficiency syndrome (AIDS)-defining conditions Cluster of differentiation 4 count < 350 cells/mm3 ii. Detectable viral load during screening or within 6 months prior to screening iii. Not receiving highly active anti-retroviral therapy iv. Had a change in antiretroviral therapy within 6 months of the start of screening v. Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the PI
- b. Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV) DNA positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-Hepatitis-C] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. Exception: Patients with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
- Active hepatitis C (HCV) infection as measured by positive HCV-ribonucleic acid (RNA) testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.
- Female patient refuses to discontinue breastfeeding her infant during study treatment or within 3 months after receiving the last dose of study treatment.
- Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤ 3 months prior to study enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities
- Unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina)
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, venous thromboembolic disease, hemorrhage, pulmonary fibrosis, pneumonitis, active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing, or psychiatric illness/social situations within 2 weeks that would limit compliance with study requirements.
- History of neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment are excluded unless deemed clinically not significant risk by the PI.
- Active malignancy other than MM requiring treatment in the past 6 months. Malignancies treated within the past 6 months that are considered cured with minimal risk of recurrence are allowed.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
- Patients with impaired decision-making capacity will not be enrolled on this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Dickran Kazandjian, MD, 305-243-5001, dkazandjian@miami.edu
Dickran Kazandjian, MD
About this study
Official title: Alpe d'Huez Study: A Parallel Two-Cohort Study of Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
The purpose of this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will:
- Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-.
- Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status.
- Increase the length of time that participants' disease responds to treatment.
The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
- Conditions
- Multiple Myeloma
- Being tested
- Linvoseltamab, Lenalidomide
- Keywords
- Newly Diagnosed 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.
LinvoseltamabBiological
Participants will receive Linvoseltamab intravenously (IV) according to the following schedule and regimen, for up to 24 cycles, each cycle lasting 28 days:
- Cycle 1 Day 1: 5mg
- Cycle 1 Day 8: 25mg
- Cycle 1 Days 15, 22: 100mg
- Cycles 2 and 3, Days 1, 8, 15, 22: 100mg
- Cycles 3 and 6, Days 1 and 15: 100mg
- Cycles 7 through 24: 100mg
LenalidomideDrug
Participants will take 10mg of Lenalidomide maintenance therapy standard of care by mouth daily from days 1 through 21 of each 28 day cycle of Linvoseltamab therapy. Lenalidomide therapy will begin on Cycle 2 Day 1 of Linvoseltamab therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Linvoseltamab Treatment Group | Experimental | Participants in this group are currently receiving lenalidomide maintenance therapy for ≤12 months will have linvoseltamab added to the lenalidomide maintenance therapy and receive treatment with the combination for up to 24 cycles.
Total participation duration is up to 4.5 years Receives: Biological: Linvoseltamab; Drug: Lenalidomide |
| Cohort 2 - Lenalidomide Treatment Group | Experimental | Participants in this group are currently receiving lenalidomide maintenance therapy but have relapsed disease within 12 months of starting maintenance will have Linvoseltamab added to lenalidomide maintenance and receive treatment with the combination for up to 24 cycles.
Total participation duration is up to 4.5 years Receives: Biological: Linvoseltamab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Residual Disease Negative Conversion Rate
The number of patients who experience MRD negativity (10^-5 sensitivity by 12 cycles of linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients.
MRD negativity rate (<10^-5) by 12 cycles of linvoseltamab
Measured: 12 months
Secondary outcomes (8)
Minimum Residual Disease Negative Conversion Rate
The number of patients who experience MRD negativity (10^-5 sensitivity) by 6 months of Linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients.
Measured: 6 months
Sustained MRD Negativity Rate
The sustained rate of MRD-negativity, at a sensitivity of <10^-5, among participants will be reported. The duration of time in months measured from the first time the participant achieves an MRD-negative bone marrow (BM) biopsy result until the time the participant has relapsed from MRD-negativity objectively documented with an MRD-positive BM result.
Measured: Up to 2 years
Overall Response Rate
The number of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response or minimal response (MR) to study therapy. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Measured: Up to 12 months
Best Overall Response (BOR)
The best overall response is defined as the best response by the percentage of participants recorded from start of study therapy until the completion of 12 cycles of study therapy. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Measured: Up to 12 months
Duration of Response (DOR)
Duration of response is defined as the elapsed time in months from the time the criteria are met for achieving partial response (PR) or better until the time of progressive disease (PD) is objectively documented. Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Measured: Up to 4.5 years
Progression-Free Survival (PFS)
PFS is defined as the elapsed time in months from the start of study therapy until first documented progressive disease (PD). Multiple myeloma (MM) response assessments will be made in accordance with modified International Myeloma Working Group (IMWG) 2016 response criteria.
Measured: Up to 4.5 years
Overall Survival (OS)
Overall survival (OS) is defined as the elapsed time in months from start of study therapy to death or censoring at last known time point that participant was known to be alive (may be based on clinic visit or phone call, etc.)
Measured: Up to 4.5 years
Number of Participants Experiencing Treatment-related Adverse Events
The number of participants experiencing all Grade and Grade ≥3 treatment-related adverse events will be recorded. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, per physician discretion.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start2 Dec 2025
- Primary completion2 Dec 2032 (estimated)
- Study completion2 Dec 2032 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dickran Kazandjian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Dickran Kazandjian, MD, University of Miami
- Investigators
- Dickran Kazandjian, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910124
- Sponsor's protocol ID
- 20241138
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpe d'Huez Study: A Parallel Two-Cohort Study of Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
- ClinicalTrials.gov ID
- NCT06910124
- Acronym / sponsor ID
- 20241138
- Conditions
- Multiple Myeloma
- Keywords
- Newly Diagnosed Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dickran Kazandjian, MDUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 2 Dec 2032 (estimated)
- Study completion
- 2 Dec 2032 (estimated)
- First posted
- 4 Apr 2025 (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 this study is to determine whether giving linvoseltamab with lenalidomide during maintenance treatment to participants with multiple myeloma will:
- Get rid of any residual multiple myeloma cells in participants' bodies which is known as minimal residual disease negative (MRD-) status. For participants that start the study with residual multiple myeloma cells in participants' bodies: to determine how long you remain MRD-.
- Increase the length of time that participants' disease is controlled. For participants with relapsed disease, to determine whether participants can re-attain MRD- status.
- Increase the length of time that participants' disease responds to treatment.
The researchers also want to find out the effects that linvoseltamab has on participants and participants' condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Linvoseltamab Treatment Group | Experimental | Biological: Linvoseltamab, Drug: LenalidomideParticipants in this group are currently receiving lenalidomide maintenance therapy for ≤12 months will have linvoseltamab added to the lenalidomide maintenance therapy and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years |
| Cohort 2 - Lenalidomide Treatment Group | Experimental | Biological: Linvoseltamab, Drug: LenalidomideParticipants in this group are currently receiving lenalidomide maintenance therapy but have relapsed disease within 12 months of starting maintenance will have Linvoseltamab added to lenalidomide maintenance and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) documented initially prior to any treatment (Kumar et al., 2016).
- Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of differentiation 38 (anti-CD38).
- Documentation of receiving induction therapy with or without high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and receiving lenalidomide maintenance therapy ≤ 12 months.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 3 (Appendix A)
- Adequate organ function
Key exclusion criteria (23 listed)
- Patients who have received prior systemic therapies for Multiple Myeloma (MM) other than initial IMiD/PI/anti CD38/HDM-ASCT-based combination therapy.
- Patients who are receiving any other investigational agents unless deemed not to interfere with the study by the Principal Investigator (PI).
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy.
- Patient has any of the following:
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 |
|---|---|---|
| LinvoseltamabParticipants will receive Linvoseltamab intravenously (IV) according to the following schedule and regimen, for up to 24 cycles, each cycle lasting 28 days: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 25mg * Cycle 1 Days 15, 22: 100mg * Cycles 2 and 3, Days 1, 8, 15, 22: 100mg * Cycles 3 and 6, Days 1 and 15: 100mg * Cycles 7 through 24: 100mg | Biological | Cohort 1 - Linvoseltamab Treatment Group, Cohort 2 - Lenalidomide Treatment Group |
| LenalidomideParticipants will take 10mg of Lenalidomide maintenance therapy standard of care by mouth daily from days 1 through 21 of each 28 day cycle of Linvoseltamab therapy. Lenalidomide therapy will begin on Cycle 2 Day 1 of Linvoseltamab therapy. | Drug | Cohort 1 - Linvoseltamab Treatment Group, Cohort 2 - Lenalidomide Treatment Group |
Primary outcome
Minimum Residual Disease Negative Conversion Rate
Time frame: 12 months
The number of patients who experience MRD negativity (10^-5 sensitivity by 12 cycles of linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients. MRD negativity rate (<10^-5) by 12 cycles of linvoseltamab
8 secondary outcomes
Minimum Residual Disease Negative Conversion Rate
Time frame: 6 months
Sustained MRD Negativity Rate
Time frame: Up to 2 years
Overall Response Rate
Time frame: Up to 12 months
Best Overall Response (BOR)
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 4.5 years
Progression-Free Survival (PFS)
Time frame: Up to 4.5 years
Overall Survival (OS)
Time frame: Up to 4.5 years
Number of Participants Experiencing Treatment-related Adverse Events
Time frame: Up to 27 months
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 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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
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.
Dickran Kazandjian, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Linvoseltamab and Lenalidomide in people with Multiple Myeloma, run by Dickran Kazandjian, MD at 1 site in United States.
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 16 inclusion and 23 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 8 Jan 2026. 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 United States. 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?
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 Dickran Kazandjian, MD (305-243-5001, dkazandjian@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Residual Disease Negative Conversion Rate (time frame: 12 months). 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 8 Jan 2026.