NCT05511428 · REGISTRY CONDITION SEARCH

Home Based Daratumumab Administration for Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2025-11-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Financial Toxicity

→

outcome · POSTED

Number of Adverse Events During Home Administration

→

outcome · POSTED

Number of Adverse Events During Infusion Center Administration

→

outcome · POSTED

Number of Patients Reporting Barriers to Home Administration At Cycle 3

→

outcome · POSTED

Number of Patients Reporting Barriers to Home Administration At Cycle 4

→

outcome · POSTED

Number of Patients Reporting Barriers to Home Administration At Cycle 5

→

outcome · POSTED

Number of Patients Reporting Barriers to Home Administration At Cycle 6

→

outcome · POSTED

Patient Perceptions of Home Based Anti-neoplastic Therapy

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

outcome · POSTED

Opportunity Cost

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive daratumumab and hyaluronidase-fihj 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.
intervention Names
Drug: Daratumumab and Hyaluronidase-fihj
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Interview
label
Treatment (daratumumab and hyaluronidase-fihj)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (daratumumab and hyaluronidase-fihj)
description
Given SC
name
Daratumumab and Hyaluronidase-fihj
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
type
DRUG
arm Group Labels
Treatment (daratumumab and hyaluronidase-fihj)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER
arm Group Labels
Treatment (daratumumab and hyaluronidase-fihj)
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER
arm Group Labels
Treatment (daratumumab and hyaluronidase-fihj)
description
Ancillary studies
name
Interview
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 20
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Patient perceptions of home based anti-neoplastic therapy will be measured through semi-structured interviews.
measure
Patient Perceptions of Home Based Anti-neoplastic Therapy
time Frame
Cycle 3 through Cycle 6, days 57-169
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 1, Baseline
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 2, Day 29
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 3, Day 57
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 4, Day 85
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 5, Day 113
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 6, Day 141
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 7, Day 169
description
Opportunity cost will be measured through the Oncology Opportunity Cost Assessment Tool (OOCAT) survey.
measure
Opportunity Cost
time Frame
At Visit 8, Day 197

primary Outcomes

description
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.
measure
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1
time Frame
At Visit 1,Baseline
description
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.
measure
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2
time Frame
At Visit 2, Day29
description
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.
measure
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
description
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.
measure
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
description
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.
measure
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
description
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.
measure
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
description
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.
measure
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
description
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.
measure
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

secondary Outcomes

description
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).
measure
Number of Participants With Medication Adherence in Home Setting During Cycle 3
time Frame
At Visit 3,Day 57
description
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).
measure
Number of Participants With Medication Adherence in Home Setting During Cycle 4
time Frame
At Visit 4,Day 85
description
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).
measure
Number of Participants With Medication Adherence in Home Setting During Cycle 5
time Frame
At Visit 5,Day 113
description
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).
measure
Number of Participants With Medication Adherence in Home Setting During Cycle 6
time Frame
At Visit 6,Day 141
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1
time Frame
At Visit 1, Baseline
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2
time Frame
At Visit 2, Day 29
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3
time Frame
At Visit 3, Day 57
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4
time Frame
At Visit 4, Day 85
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5
time Frame
At Visit 5, Day 113
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6
time Frame
At Visit 6, Day 141
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7
time Frame
At Visit 7, Day 169
description
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.
measure
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8
time Frame
At Visit 8, Day 197

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-f5aca352bcf145ac042a
requested nct id
NCT05511428
primary nct id
NCT05511428
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
56218248278441103729e61e38a0cc0cf40cffcf41ed5770b2e08fa5515963d7
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-f5aca352bcf145ac042a
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT05511428
occurrences
context exact
NCT05511428
end
11
exact text
NCT05511428
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/369/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
9208728bfe64a1998e7c29f0e74fa8ee5013033558e6d971c9f0afa40d8aa71d
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice