Dose-Escalation Study of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

February 3, 2026 updated by: Genentech, Inc.

An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cevostamab (BFCR4350A) in Patients With Relapsed or Refractory Multiple Myeloma

This is a phase I, multicenter, open-label, dose-escalation study of cevostamab administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3022
        • Peter MacCallum Cancer Center
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • University of Calgary Cumming School of Medicine
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Spain
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
    • Navarre
      • Pamplona/iruña, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Hospital - Arizona
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • New York, New York, United States, 10128
        • Mount Sinai Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology - Nashville
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
  • Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved to Grade < or = 2
  • Measurable disease defined by laboratory test results
  • Female participants of childbearing age must agree to remain abstinent or use reliable contraceptive methods during the treatment period, and at least 5 months after last dose of study drug. Women must refrain from breastfeeding during the same period.
  • Male participants must agree to refrain from donating sperm, to abstain or use a condom during the treatment period, and for at least 2 months after the last dose of tocilizumab (if applicable).

Exclusion Criteria:

  • Inability to comply with protocol-mandated hospitalization and activities restrictions
  • Pregnant or breastfeeding, or planning to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of of tocilizumab (if applicable)
  • Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks before first infusion
  • Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first infusion
  • Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 12 weeks before first cevostamab infusion
  • Known treatment-related, immune-mediated adverse events associated with prior immunotherapeutic agents
  • Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first cevostamab infusion
  • Autologous stem cell transplantation (SCT) within 100 days prior to first infusion
  • Prior allogeneic SCT or solid organ transplantation
  • Absolute plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells
  • History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Patients with known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
  • Patients with lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Current or past history of central nervous system (CNS) disease, or CNS involvement by MM
  • Significant cardiovascular disease that may limit a patient's ability to adequately respond to a CRS event
  • Symptomatic active pulmonary disease requiring supplemental oxygen
  • Within 14 days prior to first cevostamab infusion: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks prior to first infusion
  • Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
  • Known or suspected chronic active EBV infection, acute or chronic hepatitis C virus (HCV) infection
  • Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
  • Recent major surgery within 4 weeks prior to first infusion
  • Human Immunodeficiency Virus (HIV) positive
  • Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment
  • Administration of a live, attenuated vaccine within 4 weeks before first cevostamab infusion or anticipation that such a live attenuated vaccine will be required during the study
  • Received systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment <=10 mg/day prednisone or equivalent within 2 weeks prior to first dose of cevostamab and, if applicable, tocilizumab premedication prior to first dose of cevostamab
  • History of illicit drug or alcohol abuse within 12 months prior to screening
  • Any medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Single Step Dose Escalation for Cevostamab
Study drug will be administered intravenously on a 21-day cycle. The step-up dose will be given on Cycle 1 Day 1 and the target dose will be given on C1D8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm B: Double Step Dose Escalation for Cevostamab
In Cycle 1, participants will receive 2 step-up doses and a target dose. The step-up dose will be given on Cycle 1 Day 1 and C1D8. The target dose will be given on C1D15. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm C: Single Step Dose Expansion for Cevostamab
The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm D: Double Step Dose Expansion for Cevostamab
The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm E: Expansion Phase for Tocilizumab Pretreatment
All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Drug: Tocilizumab
Tocilizumab will be administered as premedication during Cycle 1.
Other Names:
  • Actemra/RoActemra
Experimental: Arm F: Single Step Dose Expansion for Cevostamab
The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm G: Double Step Dose Expansion for Cevostamab
The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm H: Triple Step Dose Escalation for Cevostamab
In Cycle 1, participants will receive 3 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 2-4, 8, and 9-11. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm I: Triple Step Dose Expansion for Cevostamab
The triple step dose expansion stage of the study may use the dosing and assessment schedule from the triple step dose escalation arm in Cycle 1, based on data from Arm H.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Experimental: Arm J: Expansion Phase for Tocilizumab Pretreatment
All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797
Drug: Tocilizumab
Tocilizumab will be administered as premedication during Cycle 1.
Other Names:
  • Actemra/RoActemra
Experimental: Arm K: Compressed Double Step Dose Expansion for Cevostamab
In Cycle 1, participants will receive 2 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 4, and 8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.
Drug: Cevostamab
Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Other Names:
  • BFCR4350A; RO7187797

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 8 years
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Up to approximately 8 years
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time Frame: Up to approximately 8 years
Dose-Limiting Toxicities (DLTs) will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), except for Cytokine release syndrome (CRS), which will be graded according to the American Society of Transplantation and Cellular Therapy (ASTCT) Consensus Grading for Cytokine Release Syndrome.
Up to approximately 8 years
Arms E and J Only: Incidence and Severity of Cytokine-release Syndrome (CRS) Following Tocilizumab Premedication Followed by Treatment with Cevostamab
Time Frame: Up to approximately 8 years
Cytokine release syndrome was recorded as an AE that generally occurs >30 minutes after the start of Cevostamab administration and at any time afterward in a given cycle.
Up to approximately 8 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve (AUC) of Cevostamab
Time Frame: Up to approximately 8 years
Defined as the total exposure of study drug.
Up to approximately 8 years
AUC of Tocilizumab
Time Frame: Up to approximately 8 years
Defined as the total exposure of study drug.
Up to approximately 8 years
Maximum Observed Serum Concentration (Cmax) of Cevostamab
Time Frame: Up to approximately 8 years
Defined as the maximum observed serum concentration of study drug.
Up to approximately 8 years
Cmax of Tocilizumab
Time Frame: Up to approximately 8 years
Defined as the maximum observed serum concentration of study drug.
Up to approximately 8 years
Minimum Observed Serum Concentration (Cmin) of Cevostamab
Time Frame: Up to approximately 8 years
Defined as the minimum observed serum concentration of study drug.
Up to approximately 8 years
Cmin of Tocilizumab
Time Frame: Up to approximately 8 years
Defined as the minimum observed serum concentration of study drug.
Up to approximately 8 years
Clearance (CL) of Cevostamab
Time Frame: Up to approximately 8 years
Defined as the volume of plasma cleared of the drug per unit time.
Up to approximately 8 years
CL of Tocilizumab
Time Frame: Up to approximately 8 years
Defined as the volume of plasma cleared of the drug per unit time.
Up to approximately 8 years
Volume of Distribution at Steady State (Vdss) of Cevostamab
Time Frame: Up to approximately 8 years
Defined as the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.
Up to approximately 8 years
Vdss of Tocilizumab
Time Frame: Up to approximately 8 years
Defined as the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.
Up to approximately 8 years
Serum Concentration of Cevostamab
Time Frame: Up to approximately 8 years
Up to approximately 8 years
Serum Concentration of Tocilizumab
Time Frame: Up to approximately 8 years
Up to approximately 8 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 8 years

ORR is defined as percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) .

sCR is defined as CR (as defined below), plus: Normal FLC ratio and absence of clonal cells in bone marrow (BM) by immunohistochemistry (kappa/lambda ratio </=4:1 or >/=1:2 for kappa and lambda participants, respectively after counting >/=100 plasma cells).

CR is defined as no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine, disappearance of any soft tissue plasmacytomas, and </= 5% plasma cells in BM.

VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >/=90% reduction in serum M-protein plus urine M-protein level <100 milligrams (mg)/24 hr.

PR is defined as >/= 50% reduction of serum M-protein and reduction in 24-hour urine M-protein by >/= 90% or to < 200 mg/24 hours.
Up to approximately 8 years
Duration of Response
Time Frame: Up to approximately 8 years
Time from first occurrence of ORR (defined previously) to disease progression (PD) or death from any cause. PD: increase of >/=25% from lowest response value in one of the following: serum M-protein (absolute increase >/=0.5 grams per deciliter (g/dL); serum M-protein increase >/=1g/dL, if lowest M component was >/=5g/dL; urine M-protein (absolute increase >/=200 mg/24 hours); no measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); no measurable serum and urine M-protein levels and no measurable disease by FLC: BM plasma cell % irrespective of baseline status (absolute % >/=10%); new lesion(s) >/=50% increase from lowest point in sum of the products of diameters of > 1 lesion, or >/=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis; >/=50% increase in circulating plasma cells (minimum 200 cells per microliter) if only measure of disease.
Up to approximately 8 years
Change from Baseline in the Presence Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 8 years
To evaluate the immune response to the study drug.
Up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO39775
  • 2018-001041-13 (EudraCT Number)
  • 2022-502053-34-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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