High Risk Newly Diagnosed Multiple MyelomaPhase 2NCT07053436
Horizon Two: HR NDMM (MMRC-100)
A Phase 2 study testing Bispecific Monoclonal Antibody and Triplet Therapy and Monoclonal Antibody with Stem Cell Transplant in people with High Risk Newly Diagnosed Multiple Myeloma, run by Multiple Myeloma Research Consortium at 12 sites in United States.
Trial summary
The Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk newly diagnosed multiple myeloma patients using an integrated and patient-centric clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Newly Diagnosed Multiple Myeloma
- What is being tested?
- Bispecific Monoclonal Antibody and Triplet Therapy and Monoclonal Antibody with Stem Cell Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 12 sitesUnited States
- Study dates
- 30 Apr 2026to 12 Oct 2035
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate by giving written informed consent
- -≥18 years of age
- Symptomatic and transplant eligible newly diagnosed multiple myeloma histologically confirmed per IMWG criteria that is high-risk as defined by at least one of the following:
- Del(17p) (CCF ≥ 20%, by analyses conducted on CD138-positive/purified cells) and/or TP53 mutation assessed by NGS
- One of these translocations-t(4;14) or t(14;16) or t(14;20)-co-occurring with +1q and/or del(1p32)
- Monoallelic del(1p32) along with +1q, or biallelic del(1p32)
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- High β2M (≥5.5 mg/dL) with normal creatinine (<1.2 mg/dL)
- Presence of extra-medullary disease non-contiguous with bone at diagnosis (by PET-CT or Whole Body MRI)
- Primary plasma cell leukemia (circulating plasma cells > 5% at diagnosis)
- No more than 2 cycles of NCCN listed induction therapy for multiple myeloma
- Measurable disease, per IMWG criteria, at time of diagnosis defined as one of the following:
- Serum M-protein at diagnosis ≥ 0.5g/dL (0.3 g/dL or above if IgA subtype)
- Urine M-protein ≥ 200 mg/24hours
- Serum free light chain difference > 100 mg/L
- Plasmacytoma ≥ 2cm
- Bone marrow involvement ≥ 30%
- ECOG performance status of 0-2
- Adequate organ function, as indicated by the following laboratory values:
- Adequate hematological function, defined as ANC ≥ 1000/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥ 8 g/dL (transfusion and/or growth factor support is allowed for hematologic parameters as long as the investigator deems the patient otherwise fit for screening)
- Adequate hepatic function, defined as total bilirubin level ≤ 1.5 x institutional upper limit of normal (IULN) except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 x IULN is required), AST ≤ 2.5 x IULN, and ALT ≤ 2.5 x IULN
- Adequate renal function, defined as calculated creatinine clearance ≥ 30 mL/min per institutional standard (assessment method should be recorded, measured or C-G acceptable)
- Persons of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of trial medication). Non-childbearing potential for a person assigned as female at birth is defined as 1 of the following:
- --≥ 45 years of age and has not had menses for >1 year
- Amenorrheic for > 2 years without a hysterectomy and/or oophorectomy and follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
- Status is post-hysterectomy, -oophorectomy, or -tubal ligation
- Persons of childbearing potential must be willing to use highly effective contraceptive measures during sexual contact with a person assigned as male at birth starting with the Screening visit through 90 days after last dose of trial medication.
- --Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
- Persons assigned as male at birth with a partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of trial medication is received. Persons assigned as male at birth with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
- --Note: Abstinence is acceptable if this is the established and preferred contraception method for the participant.
- Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. To be eligible for this trial, participants should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
- Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of the investigational arms are eligible for this trial.
- Known HIV infection and on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated.
- History of hepatitis C virus (HCV) infection must have been treated and cured. For patients with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Willing and able to comply with the requirements of the protocol.
Who cannot join
- Major concurrent illness or organ dysfunction including but not limited to the following:
- POEMS syndrome
- Symptomatic major organ involvement AL amyloidosis
- History of allergy or known hypersensitivity to any of the trial therapies or any of their excipients, or contraindication to any of the trial therapies as outlined in the local prescribing information (e.g., United States Prescribing Information [USPI])
- Complete spinal cord compression or CNS involvement
- Known leptomeningeal disease
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- Allogeneic tissue/solid organ transplant recipients with chronic GVHD requiring steroid equivalent dose of > 20 mg prednisone
- Active infection requiring treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- Legally incapacitated or has limited legal capacity
- Persons who are pregnant or breastfeeding
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30017
Bryan Burton, 404-727-7631, bryan.james.burton@emory.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Kiana Mahdaviani, 617-667-7000, kmahdavi@bidmc.harvard.edu
- Recruiting
UNC
Chapel Hill, North Carolina, 27599
Courtney Kelly, 919-962-8335, courtney_kelly@med.unc.edu
- Recruiting
Atrium Levine Cancer institute
Charlotte, North Carolina, 28203
tiffany Drennan, 800-821-1535, Tiffany.Drennan@atriumhealth.org
- Recruiting
UChicago Medicine
Chicago, Illinois, 60637
Joanna Pagacz, 1-888-824-0200, joanna.pagacz@bsd.uchicago.edu
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Christy Houde, 800-527-6266, houdec@karmanos.org
- Recruiting
City of Hope
Duarte, California, 91010
Ann Morales, 877-503-2656, amamanee@coh.org
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Austin Windsor, 877-836-6662, awindsor@tnonc.com
- Recruiting
Mt. Sinai School of Medicine
New York, New York, 10029
Anna Blangiardo, 1-800-637-4624, anna.blangiardo@mssm.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Laura Guttentag, guttenl@mskcc.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Jessica Haug, 507-266-7890, Haug.Jessica@mayo.edu
- Recruiting
Washington University Medical Center
St Louis, Missouri, 63130
Alexander Craig, craiga@wustl.edu
About this study
Official title: MMRC Horizon Two: A Phase II Randomized Adaptive Platform Trial Integrating Novel Therapies in High-Risk-Newly Diagnosed Multiple Myeloma (MMRC-100)
The Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk newly diagnosed multiple myeloma patients using an integrated and patient-centric clinical research platform that enables longitudinal learning and sharing of knowledge and investigates multiple novel therapeutic strategies within one trial platform.
Read the detailed description
The master protocol has broad scope and substantial flexibility, allowing each investigational arm within the platform to have its own design. The master protocol specifies general principles but the analysis plan for each investigational arm will be specified in its appendix. Details outlined in each investigational arm's appendix will include any co-primary endpoints (if applicable), the comparator arm, sample size and justification, inclusion of a safety run-in (if required), and any potential adaptations within the appendix. Accrual to an investigational arm will terminate in accord with its appendix.
As an adaptive platform trial, MMRC Horizon Two will evaluate multiple investigational arms against common controls. It is expected that the common controls may vary over time as standard of care therapy evolves. An initial common control arm will be specified in the control arm appendix. Changes in the common controls will be made through amendments to this appendix.
All patients will be randomized to an arm in the study. The default for the platform will be equal randomization to all arms that a patient is eligible. However, when there are more than two investigational arms and response adaptive randomization is deemed beneficial, it may be implemented in the trial.
Participants will be on study for 5 years from the date of randomization, inclusive of treatment and follow-up periods. Specifics on treatment duration and duration of follow up will be included in the respective arm appendix.
- Being tested
- Bispecific Monoclonal Antibody and Triplet Therapy, Monoclonal Antibody with Stem Cell Transplant
- Keywords
- Horizon, Horizon Two, MMRC, HR NDMM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispecific Monoclonal Antibody and Triplet TherapyDrug
Also called Linvoseltamab
Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy
Monoclonal Antibody with Stem Cell TransplantDrug
Also called Isatuximab
Isatuximab-KRd with Autologous Stem Cell Transplant
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Isa-KRd with Autologous Stem Cell Transplant | Active comparator | Appendix A to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Isa-KRd with Autologous Stem Cell Transplant in Patients with High Risk Newly Diagnosed Multiple Myeloma Receives: Drug: Monoclonal Antibody with Stem Cell Transplant |
| Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy | Experimental | Appendix B to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma Receives: Drug: Bispecific Monoclonal Antibody and Triplet Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained measurable residual disease (MRD) negativity
Sustained MRD negativity is defined as MRD negativity at a minimum threshold of one myeloma cell in one hundred thousand nucleated bone marrow cells at MRD assessments
Measured: 2 years post randomization
Progression Free Survival
PFS is defined as time from randomization to disease progression or death from any cause. Participants who have not progressed or died are censored at the date last known progression-free.
Measured: through study completion, roughly 5 years
Secondary outcomes (7)
Objective response rate (ORR)
ORR is defined as the percentage of people who have achieved a partial response (PR) or better according to the IMWG criteria within the defined period of time on trial.
Measured: 2 years
Best overall response
Best overall response (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], Partial Response [PR], Stable Disease [SD], Progressive Disease [PD]) by International Myeloma Working Group Response Criteria.
Measured: 2 years
Two-year progression free survival rate
Two-year progression free survival rate is defined as the proportion of participants alive and progression-free 24 months after randomization.
Measured: 24 months after randomization
Overall survival (OS)
OS is defined as the time from randomization to death. Alive participants are censored at the date last known alive.
Measured: through study completion, average of 5 years
Duration of response (DoR)
DoR is defined as time from the first observation of a confirmed response [Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR)] to first documentation of disease progression or death. Participants who have not progressed or died are censored at the date last known progression-free. The start date for DoR is the date the response was first observed, not the date of confirmation.
Measured: 2 years
12-month measurable residual disease (MRD) negativity
12-month MRD negativity is defined as MRD negativity at a minimum threshold of one myeloma cell in one hundred thousand nucleated bone marrow cells at MRD assessment at disease restaging 1 (12 months±3 months from randomization). Measured using ClonoSEQ's standardized, commercial, next generation sequencing assay (preferred) or commercial multi-color flow cytometry.
Measured: 12 months from randomization
Frequency and intensity of (serious) adverse events (S)AEs
Assessed by NCI CTCAE version 5.0, including a focus on hematologic clinical laboratory abnormalities and changes.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Apr 2026
- Primary completion1 Oct 2035 (estimated)
- Study completion12 Oct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Newly Diagnosed 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive Platform
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multiple Myeloma Research Consortium
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hearn Jay Cho, MD, PhD, Principal investigator, Multiple Myeloma Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053436
- Sponsor's protocol ID
- MMRC-100
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMRC Horizon Two: A Phase II Randomized Adaptive Platform Trial Integrating Novel Therapies in High-Risk-Newly Diagnosed Multiple Myeloma (MMRC-100)
- ClinicalTrials.gov ID
- NCT07053436
- Acronym / sponsor ID
- MMRC-100
- Keywords
- Horizon, Horizon Two, MMRC, HR NDMM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Multiple Myeloma Research ConsortiumResearch network
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 1 Oct 2035 (estimated)
- Study completion
- 12 Oct 2035 (estimated)
- First posted
- 8 Jul 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 Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk newly diagnosed multiple myeloma patients using an integrated and patient-centric clinical research platform that enables longitudinal learning and sharing of knowledge and investigates multiple novel therapeutic strategies within one trial platform.
Detailed description
The master protocol has broad scope and substantial flexibility, allowing each investigational arm within the platform to have its own design. The master protocol specifies general principles but the analysis plan for each investigational arm will be specified in its appendix. Details outlined in each investigational arm's appendix will include any co-primary endpoints (if applicable), the comparator arm, sample size and justification, inclusion of a safety run-in (if required), and any potential adaptations within the appendix. Accrual to an investigational arm will terminate in accord with its appendix.
As an adaptive platform trial, MMRC Horizon Two will evaluate multiple investigational arms against common controls. It is expected that the common controls may vary over time as standard of care therapy evolves. An initial common control arm will be specified in the control arm appendix. Changes in the common controls will be made through amendments to this appendix.
All patients will be randomized to an arm in the study. The default for the platform will be equal randomization to all arms that a patient is eligible. However, when there are more than two investigational arms and response adaptive randomization is deemed beneficial, it may be implemented in the trial.
Participants will be on study for 5 years from the date of randomization, inclusive of treatment and follow-up periods. Specifics on treatment duration and duration of follow up will be included in the respective arm appendix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adaptive Platform
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Isa-KRd with Autologous Stem Cell Transplant | Active comparator | Drug: Monoclonal Antibody with Stem Cell TransplantAppendix A to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Isa-KRd with Autologous Stem Cell Transplant in Patients with High Risk Newly Diagnosed Multiple Myeloma |
| Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy | Experimental | Drug: Bispecific Monoclonal Antibody and Triplet TherapyAppendix B to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Voluntarily agree to participate by giving written informed consent
- -≥18 years of age
- Symptomatic and transplant eligible newly diagnosed multiple myeloma histologically confirmed per IMWG criteria that is high-risk as defined by at least one of the following:
- No more than 2 cycles of NCCN listed induction therapy for multiple myeloma
- Measurable disease, per IMWG criteria, at time of diagnosis defined as one of the following:
Key exclusion criteria (12 listed)
- Major concurrent illness or organ dysfunction including but not limited to the following:
- History of allergy or known hypersensitivity to any of the trial therapies or any of their excipients, or contraindication to any of the trial therapies as outlined in the local prescribing information (e.g., United States Prescribing Information [USPI])
- Complete spinal cord compression or CNS involvement
- Known leptomeningeal disease
- Allogeneic tissue/solid organ transplant recipients with chronic GVHD requiring steroid equivalent dose of > 20 mg prednisone
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 |
|---|---|---|
| Bispecific Monoclonal Antibody and Triplet TherapyAlso: LinvoseltamabInduction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy | Drug | Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy |
| Monoclonal Antibody with Stem Cell TransplantAlso: IsatuximabIsatuximab-KRd with Autologous Stem Cell Transplant | Drug | Control Arm: Isa-KRd with Autologous Stem Cell Transplant |
Primary outcome
Sustained measurable residual disease (MRD) negativity
Time frame: 2 years post randomization
Sustained MRD negativity is defined as MRD negativity at a minimum threshold of one myeloma cell in one hundred thousand nucleated bone marrow cells at MRD assessments
Progression Free Survival
Time frame: through study completion, roughly 5 years
PFS is defined as time from randomization to disease progression or death from any cause. Participants who have not progressed or died are censored at the date last known progression-free.
7 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Best overall response
Time frame: 2 years
Two-year progression free survival rate
Time frame: 24 months after randomization
Overall survival (OS)
Time frame: through study completion, average of 5 years
Duration of response (DoR)
Time frame: 2 years
12-month measurable residual disease (MRD) negativity
Time frame: 12 months from randomization
Frequency and intensity of (serious) adverse events (S)AEs
Time frame: through study completion, an average of 5 years
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 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for High Risk Newly Diagnosed Multiple Myeloma
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Multiple Myeloma
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Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
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Multiple Myeloma
RecruitingPhase 1
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide for Multiple Myeloma, Newly Diagnosed AL Amyloidosis, and High-risk Smoldering Multiple Myeloma or JNJ-79635322 in Combination With Pomalidomide for Multiple Myeloma
Multiple Myeloma, Smoldering Multiple Myeloma
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Multiple Myeloma (MM)
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.
Hearn Jay Cho, MD, PhD principal investigator
Multiple Myeloma Research Foundation
12 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 Bispecific Monoclonal Antibody and Triplet Therapy and Monoclonal Antibody with Stem Cell Transplant in people with High Risk Newly Diagnosed Multiple Myeloma, run by Multiple Myeloma Research Consortium at 12 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 35 inclusion and 12 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 Jessica Vandermark (2036520457, vandermarkj@themmrf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained measurable residual disease (MRD) negativity (time frame: 2 years post randomization). The study lists 2 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 2 Oct 2026.