Multiple MyelomaPhase 1NCT06799026
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Elranatamab, GM-CSF and DC/MM Fusion Vaccine in people with Multiple Myeloma and Relapse Multiple Myeloma, run by David Avigan at 2 sites in United States.
Trial summary
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapse Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Elranatamab, GM-CSF and DC/MM Fusion Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2025to 1 Sep 2030
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an established diagnosis of multiple myeloma
- Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy
- Participants must have at least 3 prior lines of therapy
- Participants must be ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Participants must have > 20% plasma cells in the bone marrow core or aspirate differential <30 days prior to enrollment.
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- ANC > 1K/uL; Platelets > 50 K/uL without transfusional support
- Participants must have adequate organ function as defined below:
- Total bilirubin ≤1.5 x institutional upper limit of normal
- AST ≤ 3 x institutional upper limit of normal
- ALT ≤ 3 x institutional upper limit of normal
- Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
- The effects of DC/MM fusion vaccine on the developing human fetus are unknown. For this reason, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier methods of birth control or abstinence) prior to study enrollment and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of treatment.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Patients who are receiving any other investigational agents.
- Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- Patients with Plasma Cell Leukemia
- Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
- Active and clinically significant autoimmune or inflammatory disorder requiring active treatment
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- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Note: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non- invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
- Female patients who are pregnant (positive β-HCG) or breastfeeding
- Prior organ transplant requiring immunosuppressive therapy.
- Patients who previously received PD-1 antibody and have experienced toxicities resulting in treatment discontinuation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Eligibility Criteria Prior to Vaccination with DC/MM fusions
- Resolution of all elranatamab related ≥ grade 3 or higher toxicities to grade 1 or baseline. Isolated laboratory abnormalities that are not considered to be clinically significant are not exclusionary.
- Successful production of at least 2 vaccines with a minimum of 1 x 106 fusion cells per vaccine
- Absence of disease progression following 2 cycles of elranatamab therapy
- ECOG performance status ≤ 2
- Participants must have adequate organ function as defined below:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal
- AST ≤ 3 x institutional upper limit of normal
- ALT ≤ 3 x institutional upper limit of normal
- ANC > 1K/uL; Platelets > 50 K/uL without transfusional support
- Creatinine clearance ≥ 40 mL/min for participants with creatinine levels above institutional normal
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
Emma Logan, MSN, 617667-9920 ext. Logan, eklogan@bidmc.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
David Avigan, MD
About this study
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).
The names of the study drugs and vaccine involved in this study are:
- DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)
- Elranatamab (a type of T-cell engager antibody)
Read the detailed description
This is a phase 1 study to evaluate the feasibility, safety, clinical and immune effects of DC/MM fusion vaccine in combination with Elranatamab in participants with relapsed/refractory multiple myeloma. The DC/MM fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. This vaccine is individualized for each participant using dendritic cells (type of immune cells) from each participant. GM-CSF contains a substance that helps make more white blood cells. This medication is being used to possibly increase the effectiveness of the DC/MM fusion vaccine.
The U.S. Food and Drug Administration (FDA) has not approved DC/MM fusion vaccine as a treatment for Relapsed or Refractory Multiple Myeloma.
The FDA has not approved GM-CSF as a treatment for Relapsed or Refractory Multiple Myeloma.
The FDA has approved elranatamab as a treatment option for Relapsed or Refractory Multiple Myeloma.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, study drug subcutaneous (under the skin) injections, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and bone marrow biopsies and aspirations (or collections).
Participants will receive study treatment for up to 12 cycles (28-day cycles) and will be followed for up to 5 years.
It is expected that about 25 people will take part in this research study.
Pfizer is funding this research study by providing one of the study drugs, Elranatamab.
- Being tested
- Elranatamab, GM-CSF, DC/MM Fusion Vaccine
- Keywords
- MM, Multiple Myeloma, Relapse Multiple Myeloma, Refractory 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.
ElranatamabDrug
Also called PF-06863135, Elranatamab-bcmm, Elrexfio
Bispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol.
GM-CSFBiological
Also called Granulocyte-Macrophage Colony-Stimulating Factor
Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol.
DC/MM Fusion VaccineBiological
Also called Dendritic Cell/Tumor Fusion Vaccine
Dendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab + DC/MM Vaccine + GM-CSF | Experimental | * Baseline visit and assessments
* Leukapheresis
* Cycle 1 (28-day cycle):
--Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily
* Cycle 2 (28-day cycle):
--Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily
* Cycles 3 through 5 (28-day cycles):
* Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine
* Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily
* Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered)
* Cycle 6 (28-day cycle):
* Bone marrow biopsy/aspiration on Cycles 6, 9, and 12
* Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily
* Cycle 7 through 12 (28-day cycles):
* Cycle 7 Day 1 only: Bone marrow biopsy/aspiration
* Days 1 and 15: Predetermined dose of Elranatamab 1x daily
* After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6
* 6 month follow up visit
* Long term follow up 5 years Receives: Drug: Elranatamab; Biological: GM-CSF; Biological: DC/MM Fusion Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of DC/MM Vaccine
Feasibility is defined as number of patients who successfully get vaccine
Measured: 1 Year
Grade 3-4 Non-hematologic Rate
Grade 3-4 non-hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 non-hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Measured: 1 Year
Grade 3-4 hematologic Rate
Grade 3-4 hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Measured: 1 Year
Secondary outcomes (4)
Median Overall Survival (OS)
Overall survival based on the Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
Measured: 18 months
Median Progression Free Survival (PFS)
PFS based on Kaplan Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation.
Measured: 1 Year
Elranatamab Toxicity Rate
Elranatamab Toxicity Rate is defined as percentage of participants who experienced elranatamab toxicity including cytokine release syndrome, neurotoxicity and infections based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Measured: 1 Year
MRD Negative Disease Rate at 1 Year
MRD Negative Disease Rate at 1 Year is defined as the percentage of participants who are MR- negative after 1 year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start31 Jan 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Avigan
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, David Avigan, Beth Israel Deaconess Medical Center
- Investigators
- David Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799026
- Sponsor's protocol ID
- 24-439
- Status last verified
- May 2026
- First submitted
- 23 Jan 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06799026
- Acronym / sponsor ID
- 24-439
- Keywords
- MM, Multiple Myeloma, Relapse Multiple Myeloma, Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- David AviganUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 29 Jan 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.
This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).
The names of the study drugs and vaccine involved in this study are:
- DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)
- Elranatamab (a type of T-cell engager antibody)
Detailed description
This is a phase 1 study to evaluate the feasibility, safety, clinical and immune effects of DC/MM fusion vaccine in combination with Elranatamab in participants with relapsed/refractory multiple myeloma. The DC/MM fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. This vaccine is individualized for each participant using dendritic cells (type of immune cells) from each participant. GM-CSF contains a substance that helps make more white blood cells. This medication is being used to possibly increase the effectiveness of the DC/MM fusion vaccine.
The U.S. Food and Drug Administration (FDA) has not approved DC/MM fusion vaccine as a treatment for Relapsed or Refractory Multiple Myeloma.
The FDA has not approved GM-CSF as a treatment for Relapsed or Refractory Multiple Myeloma.
The FDA has approved elranatamab as a treatment option for Relapsed or Refractory Multiple Myeloma.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, study drug subcutaneous (under the skin) injections, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, and bone marrow biopsies and aspirations (or collections).
Participants will receive study treatment for up to 12 cycles (28-day cycles) and will be followed for up to 5 years.
It is expected that about 25 people will take part in this research study.
Pfizer is funding this research study by providing one of the study drugs, Elranatamab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab + DC/MM Vaccine + GM-CSF | Experimental | Drug: Elranatamab, Biological: GM-CSF, Biological: DC/MM Fusion Vaccine* Baseline visit and assessments * Leukapheresis * Cycle 1 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 2 (28-day cycle): --Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycles 3 through 5 (28-day cycles): * Bone marrow biopsy/aspiration prior to first DC/MM fusion vaccine * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Day 8: Predetermined doses of DC/MM fusion vaccine 1x daily and GM-CSF 1x daily (GM-CSF for days 9 through 11 are self-administered) * Cycle 6 (28-day cycle): * Bone marrow biopsy/aspiration on Cycles 6, 9, and 12 * Days 1, 8, 15, and 22: Predetermined dose of Elranatamab 1x daily * Cycle 7 through 12 (28-day cycles): * Cycle 7 Day 1 only: Bone marrow biopsy/aspiration * Days 1 and 15: Predetermined dose of Elranatamab 1x daily * After end of treatment, bone marrow biopsy/aspiration at months 1, 3, and 6 * 6 month follow up visit * Long term follow up 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must have an established diagnosis of multiple myeloma
- Participant must have multiple myeloma and have relapsed following or are refractory to proteasome inhibitors, IMiDs and anti-CD38 mAb therapy
- Participants must have at least 3 prior lines of therapy
- Participants must be ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (23 listed)
- Patients who are receiving any other investigational agents.
- Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence- Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
- Patients with Plasma Cell Leukemia
- Because of compromised cellular immunity, patients who have a known human immunodeficiency virus (HIV), active hepatitis C virus (HCV) or active hepatitis B virus (HBV).
- Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| ElranatamabAlso: PF-06863135, Elranatamab-bcmm, ElrexfioBispecific T-cell engager antibody, 1.9 and 1.1 mL vials, via subcutaneous (under the skin) injection per protocol. | Drug | Elranatamab + DC/MM Vaccine + GM-CSF |
| GM-CSFAlso: Granulocyte-Macrophage Colony-Stimulating FactorGranulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous (under the skin) injection per protocol. | Biological | Elranatamab + DC/MM Vaccine + GM-CSF |
| DC/MM Fusion VaccineAlso: Dendritic Cell/Tumor Fusion VaccineDendritic Cell and tumor fusion vaccine, via subcutaneous (under the skin) injection per protocol. | Biological | Elranatamab + DC/MM Vaccine + GM-CSF |
Primary outcome
Administration of DC/MM Vaccine
Time frame: 1 Year
Feasibility is defined as number of patients who successfully get vaccine
Grade 3-4 Non-hematologic Rate
Time frame: 1 Year
Grade 3-4 non-hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 non-hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Grade 3-4 hematologic Rate
Time frame: 1 Year
Grade 3-4 hematologic Rate is defined as the percentage of participants who experienced a maximum grade 3/4 hematologic based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
4 secondary outcomes
Median Overall Survival (OS)
Time frame: 18 months
Median Progression Free Survival (PFS)
Time frame: 1 Year
Elranatamab Toxicity Rate
Time frame: 1 Year
MRD Negative Disease Rate at 1 Year
Time frame: 1 Year
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 7 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
David Avigan, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elranatamab, GM-CSF and DC/MM Fusion Vaccine in people with Multiple Myeloma and Relapse Multiple Myeloma, run by David Avigan at 2 sites 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 14 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 David Avigan, MD (617-667-9920, davigan@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administration of DC/MM Vaccine (time frame: 1 Year). 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 7 May 2026.