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Completed

NCT Number: NCT05511428

Home Based Daratumumab Administration for Patients With Multiple Myeloma

This clinical trial tests the treatment effect of home based daratumumab administration in treating patients with multiple myeloma. Darzalex Faspro is a combination of two drugs (daratumumab and hyaluronidase) used to treat adults with multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Standard medical care requires Darzalex-Faspro treatment be administered during visits to the cancer center. Receiving medication in the home setting, may decrease cost and burden of care in patients with multiple myeloma.

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Key information

Conditions

Plasma Cell Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

PRIMARY OBJECTIVE:

I. Evaluate treatment burden (using the Cancer Treatment Satisfaction Questionnaire [CTSQ]).

SECONDARY OBJECTIVES:

I. Determine adherence to home delivery of daratumumab and hyaluronidase-fihj (darzalex faspro).

II. Evaluate quality of life (using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-30]) based on site of care (home versus [vs.] infusion center).

III. Evaluate financial burden (using the COST survey) based on site of care (home vs. infusion center).

IV. Evaluate Safety of home administration of darzalex-faspro. V. Evaluate barriers to home administration.

EXPLORATORY OBJECTIVES:

I. Evaluate patient perceptions of home administration of anti-neoplastic therapy.

II. Evaluate opportunity cost based on site of care (home vs. infusion center) (using the Oncology Opportunity Cost Assessment Tool [OOCAT] survey).

OUTLINE:

Patients receive daratumumab and hyaluronidase-fihj subcutaneously (SC) over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, aged greater than 18 years of age
  • Has a diagnosis of Multiple Myeloma
  • Is on the monthly phase of daratumumab (either intravenous [IV] or subcutaneous [SubQ]) based regimen (every 4 weeks) (either monotherapy or in combination with oral agents)
  • Is willing to receive daratumumab subcutaneous injections
  • Lives within the range of Jefferson Home Infusion Services
  • Patients are willing to allow home infusion company visit them and administer Darzalex-Faspro in the home
  • Women of reproductive potential must use highly effective contraception
  • Men of reproductive potential must use highly effective contraception
  • Absolute neutrophil count (ANC) > 1,000
  • Platelet count > 50,000
  • Aspartate aminotransferase (AST) / alanine transaminase (ALT) < 2.5 times upper limit of normal (ULN)
  • Bilirubin < 2 times ULN
  • Creatinine clearance (CrCl) >= 20 mL/min for single agent subcutaneous (SC) daratumumab. For combination studies: with lenalidomide >= 30 mL/min
  • English speaking

Exclusion criteria

  • Receiving daratumumab for an indication other than multiple myeloma
  • Receiving daratumumab in combination with other IV or subcutaneous therapy
  • Pregnancy or lactation
  • Known allergic reactions to components of the study product(s)
  • Uncontrolled human immunodeficiency virus (HIV)
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]) who are not on hepatitis B prophylaxis. Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive and not on Hep B prophylaxis will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV deoxyribonucleic acid (DNA) by PCR
  • Patients with reactivation of hepatitis B will be excluded
  • Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy)
  • Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is < 50% of predicted normal
  • Moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate
  • Clinically significant cardiac disease, including:
  • Myocardial infarction within 6 months before randomization, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)
  • Uncontrolled cardiac arrhythmia
  • Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Fridericia's formula > 470 msec
  • Non-English Speaking

Treatment and study plan

Daratumumab and Hyaluronidase-fihj

Drug

Given SC

Other names: DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab with rHuPH20, Daratumumab-rHuPH20, Daratumumab/Hyaluronidase-fihj, Daratumumab/rHuPH20 Co-formulation, Darzalex Faspro, Darzalex/rHuPH20, HuMax-CD38-rHuPH20, Recombinant Human Hyaluronidase Mixed with Daratumumab

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

interview

Other

Ancillary studies

Primary outcomes

  1. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1

    Time frame: At Visit 1,Baseline

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  2. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2

    Time frame: At Visit 2, Day29

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  3. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3

    Time frame: At Visit 3, Day 57

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  4. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4

    Time frame: At Visit 4, Day 85

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  5. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5

    Time frame: At Visit 5, Day 113

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  6. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6

    Time frame: At Visit 6, Day 141

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  7. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7

    Time frame: At Visit 7, Day 169

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

  8. Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8

    Time frame: At Visit 8, Day 197

    Treatment satisfaction was assessed using the Satisfaction with Therapy (SWT) subscale of the Cancer Treatment Satisfaction Questionnaire (CTSQ). The Cancer Therapy Satisfaction Questionnaire (CTSQ) measures a patient's satisfaction with cancer treatment across several domains. The SWT score ranges from 0 to 100, where a higher score represents a better outcome, indicating greater satisfaction or fewer issues. Results are represented as the mean SWT score and the standard deviation (SD) at each specified cycle.

Secondary outcomes

  1. Number of Participants With Medication Adherence in Home Setting During Cycle 3

    Time frame: At Visit 3,Day 57

    Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).

  2. Number of Participants With Medication Adherence in Home Setting During Cycle 4

    Time frame: At Visit 4,Day 85

    Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).

  3. Number of Participants With Medication Adherence in Home Setting During Cycle 5

    Time frame: At Visit 5,Day 113

    Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).

  4. Number of Participants With Medication Adherence in Home Setting During Cycle 6

    Time frame: At Visit 6,Day 141

    Adherence is defined as completing administration of medication in the home setting during cycles 3-6. Adherence will be measured for each dose given and failure would occur if the participant needs to go to the infusion center for administration for whatever reason. Based on previous studies of home based administration adherence rates over 75% would be needed to meet criteria for feasibility. The adherence at the home setting cycles will be analyzed in repeated measures logistic regression model with a random effect of patient and the fixed effect of the delivery mode (home vs. infusion center).

  5. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1

    Time frame: At Visit 1, Baseline

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  6. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2

    Time frame: At Visit 2, Day 29

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  7. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3

    Time frame: At Visit 3, Day 57

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  8. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4

    Time frame: At Visit 4, Day 85

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  9. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5

    Time frame: At Visit 5, Day 113

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  10. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6

    Time frame: At Visit 6, Day 141

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  11. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7

    Time frame: At Visit 7, Day 169

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  12. Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8

    Time frame: At Visit 8, Day 197

    Global Health Status was assessed using the Global Health Status/QoL subscale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30). Scores range from 0-100, with higher scores indicating better global health status and quality of life. Results represent the mean Global Health Status/QoL score and standard deviation (SD) for each arm at the specified cycle.

  13. Financial Toxicity

    Time frame: At Visit 1, Baseline

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  14. Financial Toxicity

    Time frame: At Visit 2, Day 29

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  15. Financial Toxicity

    Time frame: At Visit 3, Day 57

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  16. Financial Toxicity

    Time frame: At Visit 4, Day 85

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  17. Financial Toxicity

    Time frame: At Visit 5, Day 113

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  18. Financial Toxicity

    Time frame: At Visit 6, Day 141

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  19. Financial Toxicity

    Time frame: At Visit 7, Day 169

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  20. Financial Toxicity

    Time frame: At Visit 8, Day 197

    Financial toxicity will be measured using the COST survey. FACIT-COST (v2) score (range: 0-44). A lower score indicates higher financial toxicity, while a higher score implies better financial well-being.

  21. Number of Adverse Events During Home Administration

    Time frame: Cycle 3 through Cycle 6, days 57-169

    Safety will be evaluated through collection of adverse events. Total number of adverse events occurring more than 1% of the time that occured during cycle 3-6, when Darzalex-Faspro was administered at home.

  22. Number of Adverse Events During Infusion Center Administration

    Time frame: Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197

    Safety will be evaluated through collection of adverse events. Total number of adverse events that occurred more than 1% of the time during cycles 1, 2, 7, and 8 when Darzalex-Faspro was administered at the infusion center.

  23. Number of Patients Reporting Barriers to Home Administration At Cycle 3

    Time frame: At Visit 3, Day 57

    Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 3. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.

  24. Number of Patients Reporting Barriers to Home Administration At Cycle 4

    Time frame: At Visit 4, Day 85

    Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 4. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.

  25. Number of Patients Reporting Barriers to Home Administration At Cycle 5

    Time frame: At Visit 5, Day 113

    Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 5. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.

  26. Number of Patients Reporting Barriers to Home Administration At Cycle 6

    Time frame: At Visit 6, Day 141

    Barriers to receiving home administration were assessed using binary (yes/no) questionnaire administered at Cycle 6. Participants were asked whether they experienced any barriers to home infusion, including delays in treatment related to delivery of medication, arrival time of the infusion nurse, issues related to storage of medication, issues related to administration of the medication. The outcome reflects the total number of participants who responded, "yes" to any barriers to home based therapy, based on binary (yes/no) questionnaire.

Other outcomes

  1. Patient Perceptions of Home Based Anti-neoplastic Therapy

    Time frame: Cycle 3 through Cycle 6, days 57-169

    Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.

  2. Opportunity Cost

    Time frame: At Visit 1, Baseline

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  3. Opportunity Cost

    Time frame: At Visit 2, Day 29

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  4. Opportunity Cost

    Time frame: At Visit 3, Day 57

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  5. Opportunity Cost

    Time frame: At Visit 4, Day 85

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  6. Opportunity Cost

    Time frame: At Visit 5, Day 113

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  7. Opportunity Cost

    Time frame: At Visit 6, Day 141

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  8. Opportunity Cost

    Time frame: At Visit 7, Day 169

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

  9. Opportunity Cost

    Time frame: At Visit 8, Day 197

    Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2022
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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