Trial Outcomes & Findings for Home Based Daratumumab Administration for Patients With Multiple Myeloma (NCT NCT05511428)

Last Updated: 2025-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

At Visit 1,Baseline

Results posted on

2025-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (daratumumab and hyaluronidase-fihj) 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (daratumumab and hyaluronidase-fihj) 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

Home Based Daratumumab Administration for Patients With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Daratumumab and Hyaluronidase-fihj) n=20 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Age, Categorical <=18 years	0 Participants n=68 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=68 Participants
Age, Categorical >=65 years	11 Participants n=68 Participants
Sex: Female, Male Female	10 Participants n=68 Participants
Sex: Female, Male Male	10 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	10 Participants n=68 Participants
Race (NIH/OMB) White	10 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants

PRIMARY outcome

Timeframe: At Visit 1,Baseline

Population: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 19 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 1	87.2 scores on a scale (0-100) Standard Deviation 10.5

PRIMARY outcome

Timeframe: At Visit 2, Day29

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 2	87.4 scores on a scale (0-100) Standard Deviation 7.9

PRIMARY outcome

Timeframe: At Visit 3, Day 57

Population: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 18 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=18 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 3	89.3 scores on a scale (0-100) Standard Deviation 10.2

PRIMARY outcome

Timeframe: At Visit 4, Day 85

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 4	86.1 scores on a scale (0-100) Standard Deviation 10.3

PRIMARY outcome

Timeframe: At Visit 5, Day 113

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 5	88.2 scores on a scale (0-100) Standard Deviation 9.5

PRIMARY outcome

Timeframe: At Visit 6, Day 141

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=18 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 6	85.7 scores on a scale (0-100) Standard Deviation 14.1

PRIMARY outcome

Timeframe: At Visit 7, Day 169

Population: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=16 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 7	89.7 scores on a scale (0-100) Standard Deviation 11.8

PRIMARY outcome

Timeframe: At Visit 8, Day 197

Population: Although 20 participants were enrolled in the study, not all participants completed the CTSQ at each time point. As a result, only the 17 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=17 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Treatment Satisfaction Will be Measured Using the SWT Score From the Cancer Treatment Satisfaction Questionnaire (CTSQ) - Cycle 8	90.1 scores on a scale (0-100) Standard Deviation 12.7

SECONDARY outcome

Timeframe: At Visit 3,Day 57

Population: Participants who received at least one dose in the home setting during cycle 3.

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).

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Participants With Medication Adherence in Home Setting During Cycle 3	19 Participants

SECONDARY outcome

Timeframe: At Visit 4,Day 85

Population: Participants who received at least one dose in the home setting during cycle 4.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Participants With Medication Adherence in Home Setting During Cycle 4	19 Participants

SECONDARY outcome

Timeframe: At Visit 5,Day 113

Population: Participants who received at least one dose in the home setting during cycle 5.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Participants With Medication Adherence in Home Setting During Cycle 5	19 Participants

SECONDARY outcome

Timeframe: At Visit 6,Day 141

Population: Participants who received at least one dose in the home setting during cycle 6.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Participants With Medication Adherence in Home Setting During Cycle 6	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=20 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 1	64.2 scores on a scale (0-100) Standard Deviation 21.3

SECONDARY outcome

Timeframe: At Visit 2, Day 29

Population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 19 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 2	69.3 scores on a scale (0-100) Standard Deviation 17.4

SECONDARY outcome

Timeframe: At Visit 3, Day 57

Population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 18 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=18 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 3	64.4 scores on a scale (0-100) Standard Deviation 15.9

SECONDARY outcome

Timeframe: At Visit 4, Day 85

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 4	65.8 scores on a scale (0-100) Standard Deviation 19.6

SECONDARY outcome

Timeframe: At Visit 5, Day 113

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 5	57.5 scores on a scale (0-100) Standard Deviation 18.4

SECONDARY outcome

Timeframe: At Visit 6, Day 141

Population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 17 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=17 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 6	69.1 scores on a scale (0-100) Standard Deviation 20.8

SECONDARY outcome

Timeframe: At Visit 7, Day 169

Population: Although 20 participants were enrolled in the study, not all participants completed the EORTC QLQ-30 at each time point. As a result, only the 16 participants who provided complete and analyzable responses were included in the analysis for this outcome.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=16 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 7	69.3 scores on a scale (0-100) Standard Deviation 18.4

SECONDARY outcome

Timeframe: At Visit 8, Day 197

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=17 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Global Health Status/Quality of Life Score (EORTC QLQ-30) At Cycle 8	62.3 scores on a scale (0-100) Standard Deviation 18.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	27.0 scores on a scale (0-44) Standard Deviation 7.8

SECONDARY outcome

Timeframe: At Visit 2, Day 29

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	28.5 scores on a scale (0-44) Standard Deviation 9.9

SECONDARY outcome

Timeframe: At Visit 3, Day 57

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=18 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	24.8 scores on a scale (0-44) Standard Deviation 9.7

SECONDARY outcome

Timeframe: At Visit 4, Day 85

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	28 scores on a scale (0-44) Standard Deviation 9.2

SECONDARY outcome

Timeframe: At Visit 5, Day 113

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	26.8 scores on a scale (0-44) Standard Deviation 10.4

SECONDARY outcome

Timeframe: At Visit 6, Day 141

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=17 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	26.6 scores on a scale (0-44) Standard Deviation 10.4

SECONDARY outcome

Timeframe: At Visit 7, Day 169

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=16 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	24.7 scores on a scale (0-44) Standard Deviation 9.6

SECONDARY outcome

Timeframe: At Visit 8, Day 197

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=17 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Financial Toxicity	27.7 scores on a scale (0-44) Standard Deviation 9.0

SECONDARY outcome

Timeframe: Cycle 3 through Cycle 6, days 57-169

Population: All participants who received Darzalex-Faspro during specified cycles.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Adverse Events During Home Administration	69 adverse events

SECONDARY outcome

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

Population: All participants who received Darzalex-Faspro during specified cycles.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Adverse Events During Infusion Center Administration	82 adverse events

SECONDARY outcome

Timeframe: At Visit 3, Day 57

Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Patients Reporting Barriers to Home Administration At Cycle 3	0 Participants

SECONDARY outcome

Timeframe: At Visit 4, Day 85

Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Patients Reporting Barriers to Home Administration At Cycle 4	0 Participants

SECONDARY outcome

Timeframe: At Visit 5, Day 113

Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Patients Reporting Barriers to Home Administration At Cycle 5	0 Participants

SECONDARY outcome

Timeframe: At Visit 6, Day 141

Population: All participants who received Darzalex-Faspro in the home setting during cycles 3-6. No barriers were identified.

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.

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Number of Patients Reporting Barriers to Home Administration At Cycle 6	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Cycle 3 through Cycle 6, days 57-169

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

Outcome measures

Outcome measures
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=19 Participants 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Familiarity	2 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Overall Comfort	3 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Ability to Rest After Treatment	3 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : More Time in the Day for Work/Other Activities	3 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Eliminated Travel Inconveniences	3 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Acceptability of Home Blood Draws	2 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Positive : Satisfaction with Home Infusion Staff	2 Participants
Patient Perceptions of Home Based Anti-neoplastic Therapy Negative : Wait Times	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Visit 1, Baseline

Treatment (daratumumab and hyaluronidase-fihj)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=20 participants at risk 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Infections and infestations Lung infection	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders stomach pain	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.

Other adverse events

Other adverse events
Measure	Treatment (daratumumab and hyaluronidase-fihj) n=20 participants at risk 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. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Metabolism and nutrition disorders Anorexia	5.0% 1/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 5/20 • Number of events 5 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders Arthritis	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders Back Pain	15.0% 3/20 • Number of events 6 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders Bone Pain	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Constipation	20.0% 4/20 • Number of events 4 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 3/20 • Number of events 4 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Metabolism and nutrition disorders Dehydration	10.0% 2/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Dental carriers	5.0% 1/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Diarrhea	30.0% 6/20 • Number of events 8 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Skin and subcutaneous tissue disorders Dry Skin	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Dyspepsia	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Renal and urinary disorders Dysuria	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Ear and labyrinth disorders Ear Pain	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders Edema- limbs	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Reproductive system and breast disorders Erectile dysfunction	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Injury, poisoning and procedural complications Fall	10.0% 2/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders Fatigue	40.0% 8/20 • Number of events 9 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders Fever	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders Flue like symptoms	25.0% 5/20 • Number of events 5 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Injury, poisoning and procedural complications Fracture	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders gastritis	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Gastroesophageal reflux disease	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Gastrointestinal disorders- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Metabolism and nutrition disorders Hypokalemia	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations infections and infestations- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations infusion related reaction (zometa)	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders Injection site reaction	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations Lung infection	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Metabolism and nutrition disorders Metabolism and nutrition disorders- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders mucositis- oral	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders muscle cramp	20.0% 4/20 • Number of events 4 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders muscle weakness- lower limbs	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders myalgia	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders Neck Pain	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
General disorders non-cardiac chest pain	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Oral pain (pain in lower jaw)	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Musculoskeletal and connective tissue disorders pain in extremity	25.0% 5/20 • Number of events 9 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Nervous system disorders Paresthesia	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Peripheral sensory neuropathy	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders Postnasal drip	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Skin and subcutaneous tissue disorders Pruritus	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Skin and subcutaneous tissue disorders Rash Maculopapular	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders rectal ulcer	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations sinusitis	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Skin and subcutaneous tissue disorders Skin and subcutaneous disorders- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Skin and subcutaneous tissue disorders skin hyperpigmentation	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations skin infection	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders stomach pain	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Nervous system disorders syncope	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations upper respiratory infection	25.0% 5/20 • Number of events 5 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Renal and urinary disorders urinary frequency	10.0% 2/20 • Number of events 2 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations urinary tract infection	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Vascular disorders vascular disorders- other	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Infections and infestations viremia	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Eye disorders vision decreased	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Gastrointestinal disorders vomiting	15.0% 3/20 • Number of events 3 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.
Respiratory, thoracic and mediastinal disorders wheezing	5.0% 1/20 • Number of events 1 • The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization.

Additional Information

Adam Binder, MD

Thomas Jefferson University

Phone: 215-955-8874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place