Plasma Cell MyelomaPhase 1/2NCT03417284

Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation

A Phase 1/2 study testing Autologous Hematopoietic Stem Cell Transplantation, Filgrastim-sndz and Melphalan Hydrochloride in people with Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Plasma Cell Myeloma
What is being tested?: Autologous Hematopoietic Stem Cell Transplantation, Filgrastim-sndz and Melphalan Hydrochloride
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 9 Oct 2019to 18 Jul 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR
Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis [serum protein electrophoresis (SPEP)] and immunofixation (serum immunofixation electrophoresis [SIFE]) and the absence of Bence Jones protein in the urine [urine protein electrophoresis (UPEP)] defined by use of conventional electrophoresis and immunofixation [urine immunofixation electrophoresis (UIFE) techniques]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan.
Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
Karnofsky performance score 70% or higher.
Left ventricular ejection fraction at rest > 40% within 3 months of registration.
Bilirubin < 2 x the upper limit of normal (except patients with Gilbert syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed)

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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x the upper limit of normal.
Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation.
Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50% of predicted value (corrected for hemoglobin) within 3 months of registration.
All female and male subjects of reproductive potential must consent to the use of effective contraceptive methods as advised by the study doctor during treatment.
Signed informed consent form.

Who cannot join

Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients seropositive for the human immunodeficiency virus (HIV).
Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Patients participating in an investigational new drug protocol within 14 days before enrollment.
Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding.
Prior hematopoietic cell transplantation allogeneic or autologous (A prior autologous HCT will be allowed as long as it was part of tandem transplantation).
Prior organ transplant requiring immunosuppressive therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the optimal dose and schedule of melphalan for injection (melphalan hydrochloride [Evomela]) prior to autologous hematopoietic stem cell transplantation (auto-HCT) for multiple myeloma (MM).

II. To collect the pharmacokinetic data and compare the exposure-response evaluations between the 2 infusion schedules.

SECONDARY OBJECTIVES:

To determine the incidence of treatment related mortality (TRM) at day 90 after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.

II. To determine the rate of minimal residual disease (MRD) negative complete response (CR) rate at day 90 after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.

III. To determine the progression-free survival (PFS) after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.

OUTLINE: This is a phase I, dose escalation study of melphalan hydrochloride followed by a phase II study.

PREPARATIVE REGIMEN: Participants are randomized to 1 of 2 groups.

GROUP 1: Participants receive melphalan hydrochloride intravenously (IV) over 30-60 minutes on day -2.

GROUP 2: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.

TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.

POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz subcutaneously (SC) once daily (QD) starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an absolute neutrophil count (ANC) of 0.5 x 10^9/L.

After completion of study treatment, participants are followed up at 3 months, every 3 months for 1 year, and then annually for 1 year.

Conditions: Plasma Cell Myeloma
Being tested: Autologous Hematopoietic Stem Cell Transplantation, Filgrastim-sndz, Melphalan Hydrochloride
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called AHSCT, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous
Undergo HSCT
Filgrastim-sndzBiological
Also called Filgrastim Biosimilar Filgrastim-sndz, Zarxio
Given SC
Melphalan HydrochlorideDrug
Also called Alkeran, Alkerana, Evomela
Given IV

Study groups in NCT03417284
Study group	Role	What they receive
Group 1 (melphalan hydrochloride, HSCT, filgrastim)	Experimental	PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L. Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Filgrastim-sndz; Drug: Melphalan Hydrochloride
Group 2 (melphalan hydrochloride, HSCT, filgrastim)	Experimental	PREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L. Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Filgrastim-sndz; Drug: Melphalan Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.
Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
Measured: Within 30 days after the start of infusion

Secondary outcomes (3)

Progression-free Survival (PFS)
Number of participants that are still alive and disease free one year post autologous transplant.
Measured: From the date of Evomela injection up to 1 year
Treatment Related Mortality (TRM).
Number of participants expired from non-disease relapse within 90 days post transplant
Measured: At day 90 post-transplant
Number of Participants That Have Achieved Complete Response (CR).
Number of participants that have achieved Complete response (CR). Complete response definition is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.
Measured: At 90 days post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201918 Jul 2024

First posted31 Jan 2018
Study start9 Oct 2019
Primary completion18 Jul 2024
Study completion18 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417284
Sponsor's protocol ID: 2017-0399
Other IDs: NCI-2018-00906, 2017-0399
Status last verified: Jul 2024
First submitted: 24 Jan 2018
Last updated: 1 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bashir Q, Thall PF, Kawedia J, Xu X, Knape CG, Delgado R, Nieto Y, Saini NY, Aljawai YM, Srour SA, Ramdial JL, Hosing C, Popat UR, Oran B, Kebriaei P, Ahmed S, Pasvolsky O, Patel KK, Thomas SK, Gaballa MR, Ye JC, Orlowski RZ, Champlin RE, Shpall EJ, Qazilbash MH. Phase I/II Trial of Evomela for Autologous Transplant in Myeloma: Schedule Optimization and Matched Comparison with MEL200. Blood Adv. 2026 Jul 31:bloodadvances.2026020293. doi: 10.1182/bloodadvances.2026020293. Online ahead of print.
PubMed 42537695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Plasma Cell Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT03417284
Acronym / sponsor ID: 2017-0399
Conditions: Plasma Cell Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 9 Oct 2019 (actual)
Primary completion: 18 Jul 2024 (actual)
Study completion: 18 Jul 2024 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 1 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the optimal dose and schedule of melphalan for injection (melphalan hydrochloride [Evomela]) prior to autologous hematopoietic stem cell transplantation (auto-HCT) for multiple myeloma (MM).

II. To collect the pharmacokinetic data and compare the exposure-response evaluations between the 2 infusion schedules.

SECONDARY OBJECTIVES:

To determine the incidence of treatment related mortality (TRM) at day 90 after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.

III. To determine the progression-free survival (PFS) after auto-HCT in newly diagnosed myeloma patients treated on different schedules and doses of Evomela.

OUTLINE: This is a phase I, dose escalation study of melphalan hydrochloride followed by a phase II study.

PREPARATIVE REGIMEN: Participants are randomized to 1 of 2 groups.

GROUP 1: Participants receive melphalan hydrochloride intravenously (IV) over 30-60 minutes on day -2.

GROUP 2: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2.

TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.

After completion of study treatment, participants are followed up at 3 months, every 3 months for 1 year, and then annually for 1 year.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 (melphalan hydrochloride, HSCT, filgrastim)	Experimental	Procedure: Autologous Hematopoietic Stem Cell Transplantation, Biological: Filgrastim-sndz, Drug: Melphalan HydrochloridePREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 30-60 minutes on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.
Group 2 (melphalan hydrochloride, HSCT, filgrastim)	Experimental	Procedure: Autologous Hematopoietic Stem Cell Transplantation, Biological: Filgrastim-sndz, Drug: Melphalan HydrochloridePREPARATIVE REGIMEN: Participants receive melphalan hydrochloride IV over 8-9 hours on day -2. TRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes. POST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10^9/L.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR
Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis [serum protein electrophoresis (SPEP)] and immunofixation (serum immunofixation electrophoresis [SIFE]) and the absence of Bence Jones protein in the urine [urine protein electrophoresis (UPEP)] defined by use of conventional electrophoresis and immunofixation [urine immunofixation electrophoresis (UIFE) techniques]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan.
Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
Karnofsky performance score 70% or higher.
Left ventricular ejection fraction at rest > 40% within 3 months of registration.

Key exclusion criteria (7 listed)

Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients seropositive for the human immunodeficiency virus (HIV).
Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Patients participating in an investigational new drug protocol within 14 days before enrollment.
Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding.

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
Autologous Hematopoietic Stem Cell TransplantationAlso: AHSCT, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation, Stem Cell Transplantation, AutologousUndergo HSCT	Procedure or surgery	Group 1 (melphalan hydrochloride, HSCT, filgrastim), Group 2 (melphalan hydrochloride, HSCT, filgrastim)
Filgrastim-sndzAlso: Filgrastim Biosimilar Filgrastim-sndz, ZarxioGiven SC	Biological	Group 1 (melphalan hydrochloride, HSCT, filgrastim), Group 2 (melphalan hydrochloride, HSCT, filgrastim)
Melphalan HydrochlorideAlso: Alkeran, Alkerana, EvomelaGiven IV	Drug	Group 1 (melphalan hydrochloride, HSCT, filgrastim), Group 2 (melphalan hydrochloride, HSCT, filgrastim)

Primary outcome

Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.
Time frame: Within 30 days after the start of infusion
Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.

3 secondary outcomes

Progression-free Survival (PFS)
Time frame: From the date of Evomela injection up to 1 year
Treatment Related Mortality (TRM).
Time frame: At day 90 post-transplant
Number of Participants That Have Achieved Complete Response (CR).
Time frame: At 90 days post-transplant

Results and safety

Results posted to the registry on 1 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group1_Dose 1 200mgm2	4	3
Group 1_Dose 2 225mgm2	27	27
Group 2_Dose 1 200mgm2	4	3
Group 2_Dose 225mgm2	27	27

Primary outcome: Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.

Time frame: Within 30 days after the start of infusion. Count of participants. Unit: Participants

Measure	Group1_Dose 1 200mgm2 n = 4	Group 1_Dose 2 225mgm2 n = 27	Group 2_Dose 1 200mgm2 n = 4	Group 2_Dose 225mgm2 n = 27
Grade 4 Mucositis	0	0	0	0
Grade 4 non-hematologic or non-infectious toxicity	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to one year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group1_Dose 1 200mgm2	0 of 4 (0%)	3 of 4 (75%)	1 of 4
Group 1_Dose 2 225mgm2	0 of 27 (0%)	27 of 27 (100%)	0 of 27
Group 2_Dose 1 200mgm2	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Group 2_Dose 225mgm2	0 of 27 (0%)	27 of 27 (100%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42537695Bashir Q, Thall PF, Kawedia J, Xu X, Knape CG, Delgado R, Nieto Y, Saini NY, Aljawai YM, Srour SA, Ramdial JL, Hosing C, Popat UR, Oran B, Kebriaei P, Ahmed S, Pasvolsky O, Patel KK, Thomas SK, Gaballa MR, Ye JC, Orlowski RZ, Champlin RE, Shpall EJ, Qazilbash MH. Phase I/II Trial of Evomela for Autologous Transplant in Myeloma: Schedule Optimization and Matched Comparison with MEL200. Blood Adv. 2026 Jul 31:bloodadvances.2026020293. doi: 10.1182/bloodadvances.2026020293. Online ahead of print.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Plasma Cell 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)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Qaiser Bashir principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 7 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 1 May 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Optimal Dose and Schedule of Evomela Prior to Autologous Transplant. (time frame: Within 30 days after the start of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03417284, which also lists 1 linked publication.

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 1 May 2025.